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ASEAN MedTech Insights
ASEAN MedTech InsightsVietnam's IVD Crackdown: Pure Global on Surviving the New Regulatory Gauntlet.This week on ASEAN MedTech Insights, we're diving into the urgent regulatory crisis hitting the in-vitro diagnostics sector in Vietnam. A new government decree, now in full force, is causing major disruptions for foreign manufacturers who were once comfortable in the market. We uncover why the old rules no longer apply and what specific documentation hurdles are leading to rejected submissions and potential market lockout. Imagine your best-selling diagnostic product being barred from a market of 100 million people overnight. This is the reality facing some IVD companies in Vietnam. We break down the case of a Class C diagnostic device...
2026-01-2901 minTiếp cận Thị trường Toàn cầu cho Thiết bị Y tế
Tiếp cận Thị trường Toàn cầu cho Thiết bị Y tếTiếp Cận Thị Trường ASEAN: Hài Hòa Hóa Quy Định Thiết Bị Y Tế với AMDD & CSDTTrong tập này, chúng ta sẽ tìm hiểu cách các nhà sản xuất thiết bị y tế có thể tiếp cận các thị trường toàn cầu chưa được phục vụ đầy đủ thông qua chiến lược hài hòa hóa quy định. Chúng tôi sẽ phân tích sâu về Chỉ thị Trang thiết bị Y tế của ASEAN (AMDD) và Hồ sơ Kỹ thuật Chung (CSDT), giải thích cách chúng đơn giản hóa quy trình đăng ký, giảm chi phí và đẩy nhanh việc đưa các công nghệ cứu n...
2025-11-1303 minASEAN MedTech Insights
ASEAN MedTech InsightsASEAN MedTech Maze: Pure Global's Guide to Device Registration in Singapore, Malaysia and BeyondThis episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASEAN Common Submission Dossier Template (CSDT) and contrast it with the on-the-ground realities in key markets. We dive into the distinct regulatory pathways of Singapore, known for its efficiency and reliance on reference country approvals, and Malaysia, with its mandatory MeDC@St online portal and Conformity Assessment Body (CAB) verification system. We highlight how these subtle differences can significantly impact a company's timeline and budget. Consider the case of a US-based scaleup with an innovative cardiac monitoring...
2025-10-2101 minASEAN MedTech Insights
ASEAN MedTech InsightsPhilippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEANThis episode of ASEAN MedTech Insights provides a deep dive into the specific regulatory requirements for medical device registration in the Philippines. We unpack the critical role of the FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR) and explain why foreign manufacturers cannot go it alone, detailing the mandatory appointment of a Local Authorized Representative. We explore the entire process, from securing the essential License to Operate (LTO) to navigating the AMDD risk classification system and preparing the ASEAN Common Submission Dossier Template (CSDT). A key focus is on the strategic importance of selecting the right local partner...
2025-10-1602 minMedTech Global Insights
MedTech Global InsightsUnlock Singapore's MedTech Market: Your Expert Guide to HSA Medical Device Registration with Pure GlobalThis episode of MedTech Global Insights delves into the strategic importance and regulatory complexities of the Singaporean medical device market. We explore the Health Sciences Authority (HSA) framework, from device classification and the Common Submission Dossier Template (CSDT) to the critical role of a local Singapore Registrant. Discover how to navigate these challenges effectively. We share a detailed case study of a European IVD manufacturer that struggled with delays and submission errors when trying to enter the Singapore market alone. Learn how they overcame these hurdles with a strategic partner, leveraging existing approvals and advanced AI tools to expedite their...
2025-10-1203 minMedTech Global Insights
MedTech Global InsightsUnlocking the Singapore MedTech Market: Your Expert Guide to HSA Medical Device Approval with Pure GlobalIn this episode of MedTech Global Insights, we explore the lucrative but complex medical device market of Singapore. As a key gateway to the Asia-Pacific region, Singapore offers immense opportunities, but navigating the regulatory landscape set by the Health Sciences Authority (HSA) is a significant challenge for foreign manufacturers. We break down the critical requirements for market entry, from the mandatory appointment of a Singapore Registrant to the intricacies of the ASEAN Common Submission Dossier Template (CSDT). Learn how a strategic approach can not only ensure compliance but also accelerate your time-to-market by leveraging existing international approvals. Consider this common...
2025-10-0803 minการเข้าถึงตลาดเครื่องมือแพทย์ระดับโลก
การเข้าถึงตลาดเครื่องมือแพทย์ระดับโลกปลดล็อกตลาดไทยกับ Pure Global: รับมือการเปลี่ยนแปลงกฎเกณฑ์เครื่องมือแพทย์ตอนนี้นำเสนอภาพรวมการเปลี่ยนแปลงกฎระเบียบเครื่องมือแพทย์ในประเทศไทย จากระบบเดิมสู่การจัดกลุ่มตามความเสี่ยง 4 ระดับตามมาตรฐานสากล เราจะอธิบายว่าการเปลี่ยนแปลงนี้ส่งผลกระทบต่อผู้ผลิตอย่างไร ตั้งแต่การจัดประเภทผลิตภัณฑ์ใหม่ไปจนถึงข้อกำหนดด้านเอกสารในรูปแบบ CSDT และให้ข้อมูลเชิงลึกเพื่อเตรียมความพร้อมในการเข้าสู่ตลาดไทยอย่างราบรื่น - ทำไมประเทศไทยจึงเปลี่ยนระบบการกำกับดูแลเครื่องมือแพทย์? - การจัดกลุ่มเครื่องมือแพทย์ 4 ระดับแบบใหม่แตกต่างจากระบบเดิมอย่างไร? - CSDT คืออะไร และมีความสำคัญต่อการยื่นขออนุญาตอย่างไร? - ผู้ผลิตต้องเตรียมตัวอย่างไรเพื่อรับมือกับการเปลี่ยนแปลงครั้งใหญ่นี้? - การเปลี่ยนแปลงกฎระเบียบนี้ส่งผลดีต่อตลาดเครื่องมือแพทย์ในระยะยาวหรือไม่? - กฎใหม่นี้สอดคล้องกับแนวทางของ ASEAN AMDD อย่างไร? Pure Global นำเสนอโซลูชันที่ปรึกษาด้านกฎระเบียบครบวงจรสำหรับบริษัทเทคโนโลยีการแพทย์ (MedTech) และเครื่องมือแพทย์วินิจฉัยภายนอกร่างกาย (IVD) เราเชี่ยวชาญในการช่วยให้ท่านนำทางกฎระเบียบที่ซับซ้อนของตลาดในเอเชียตะวันออกเฉียงใต้ รวมถึงประเทศไทย ด้วยทีมผู้เชี่ยวชาญในท้องถิ่นและเครื่องมือ AI ขั้นสูง เราสามารถช่วยท่านวางกลยุทธ์การขึ้นทะเบียน จัดทำเอกสาร CSDT และทำหน้าที่เป็นตัวแทนในประเทศ เพื่อให้การเข้าสู่ตลาดของท่านรวดเร็วและเป็นไปตามข้อกำหนดอย่างสมบูรณ์ ติดต่อเราได้ที่ info@pureglobal.com หรือเยี่ยมชมเว็บไซต์ https://pureglobal.com เพื่อเรียนรู้เพิ่มเติมว่าเราจะช่วยธุรกิจของท่านให้เติบโตในตลาดโลกได้อย่างไร
2025-10-0103 minASEAN MedTech Insights
ASEAN MedTech InsightsMastering Vietnam's MedTech Market: A Pure Global Deep Dive into CSDT Technical Files for Decree 98 Success in ASEAN.This episode of ASEAN MedTech Insights provides a practical guide for MedTech manufacturers on preparing a Common Submission Dossier Template (CSDT) for market entry into Vietnam under the stringent Decree No. 98/2021/ND-CP. We dissect the critical components of the technical file, from risk classification and language requirements to the specific nuances of providing clinical evidence for the Vietnamese market. We offer actionable advice and highlight common pitfalls that can lead to costly delays and rejections by the Vietnamese Department of Medical Equipment and Construction (DMEC). This is an essential listen for any regulatory affairs professional or business leader looking to...
2025-09-3002 minMedTech Global Insights
MedTech Global InsightsUnlocking the Gateway to Asia: Why Pure Global is Your Expert Partner for Singapore Medical Device Regulatory Consulting and HSA Approval.Singapore stands as a premier destination for MedTech companies aiming to establish a presence in Asia. However, navigating the stringent and nuanced regulatory landscape of the Health Sciences Authority (HSA) can be a formidable challenge, leading to costly delays and missed opportunities. This episode of MedTech Global Insights explores the specific hurdles of entering the Singaporean market and how Pure Global provides a strategic, technology-driven solution. We delve into their unique combination of in-country expertise and advanced AI tools that transform a complex regulatory process into a streamlined path to market access and regional expansion. Consider this scenario: Your innovative...
2025-09-2903 minASEAN MedTech Insights
ASEAN MedTech InsightsCracking the ASEAN Code: A Pure Global Deep Dive into Clinical Evidence Requirements for MedTech Success in Singapore, Malaysia & VietnamThis episode of ASEAN MedTech Insights dives deep into one of the most critical and often misunderstood aspects of medical device registration in Southeast Asia: the requirements for clinical evidence. We unpack the ASEAN Consultative Committee for Standards and Quality (ACCSQ) guidance document ACCSQ/MDPWG/GL-1, explaining how to build a robust Clinical Evaluation Report (CER) for the Common Submission Dossier Template (CSDT). We explore how manufacturers can leverage existing clinical data from other major markets like the EU and US to support their ASEAN submissions. This episode provides practical, actionable insights to help you avoid common pitfalls, reduce time-to-market...
2025-09-2703 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global Presents: Your Strategic Roadmap to Medical Device Licensing in Indonesia & ASEAN - Demystifying MOH Regulation No. 62 of 2017This episode of ASEAN MedTech Insights provides a deep dive into the essential requirements of Indonesia's Minister of Health Regulation No. 62 of 2017. We break down the critical pillars for medical device registration, including the mandatory appointment of a local license holder, the four-tier risk classification system, and the meticulous documentation required in the CSDT format. We move beyond the legal text to explore the practical realities and strategic challenges that foreign manufacturers face. This is not just a theoretical overview; it's a strategic guide filled with real-world observations to help you successfully navigate the regulatory maze and unlock market access...
2025-09-2603 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global's Guide to Singapore's MedTech Regulations: Unlocking ASEAN Market Access Through Technical SpecificationsIn this episode of ASEAN MedTech Insights, we demystify the core technical specifications required under Singapore's Health Products (Medical Devices) Regulations 2010. We explore why Singapore serves as a crucial launchpad for the broader ASEAN market and break down the specific documentation demands of the Health Sciences Authority (HSA). We delve into the ASEAN Common Submission Dossier Template (CSDT), detailing the critical elements that manufacturers often overlook, from granular device descriptions and material specifications to the rigorous standards for labelling and clinical evidence. This episode is essential listening for any MedTech company planning a Southeast Asian market entry strategy. Case Study...
2025-09-2503 minASEAN MedTech Insights
ASEAN MedTech InsightsCracking the Code of Thai FDA Approval: Pure Global's Expert Insights on Complying with Thailand’s Medical Device Act B.E. 2551 for ASEAN MedTech Innovators.This episode of ASEAN MedTech Insights unpacks the essential steps to comply with Thailand’s Medical Device Act B.E. 2551. We explore the Thai FDA's risk-based classification system, the different registration pathways available to foreign manufacturers, and the critical role of a local authorized representative. Navigating this landscape is challenging. For example, a company with a successful, FDA-approved device might assume a smooth entry into Thailand, only to face unexpected delays and costs. Their submission gets stuck because their technical file isn't in the required ASEAN CSDT format, and key documents haven't been translated into Thai, highlighting how a lack of...
2025-09-2403 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global Presents: Mastering the ASEAN CSDT for MedTech Success in Singapore, Malaysia, and VietnamThis episode of ASEAN MedTech Insights dives deep into the complexities of the ASEAN Common Submission Dossier Template (CSDT). We move beyond the checklist to uncover the unwritten rules and nuanced expectations of regulators in key markets like Malaysia, Vietnam, and Indonesia. Learn why a one-size-fits-all approach fails and how specific, localized details are crucial for a successful medical device registration. We share a case study of a Swiss medical device company whose launch in Southeast Asia was delayed by four months. Their mistake. A single paragraph in their CSDT that vaguely described their software was deemed insufficient by two...
2025-09-2202 minASEAN MedTech Insights
ASEAN MedTech InsightsUnlocking ASEAN MedTech Markets: Pure Global's Deep Dive into the AMDD for Singapore, Thailand, and VietnamIn this episode of ASEAN MedTech Insights, we explore the ambitious ASEAN Medical Device Directive (AMDD). Designed to create a harmonized, single market for medical devices across ten nations, the AMDD promises streamlined access and unified standards. We break down its core requirements, from the four-tier risk classification system to the crucial Common Submission Dossier Template (CSDT). However, the vision of harmonization meets the complex reality of national implementation. We uncover why the AMDD's status as a 'directive' rather than a 'regulation' creates a fragmented landscape where a dossier approved in one country may face significant hurdles in another. This...
2025-09-2103 minASEAN MedTech Insights
ASEAN MedTech InsightsCracking the Code: A Pure Global Guide to SaMD Medical Device Registration in the Philippines for ASEAN MedTech InnovatorsThis episode of ASEAN MedTech Insights provides a deep dive into the specific requirements for registering Software as a Medical Device (SaMD) in the Philippines. We explore the critical steps from risk classification and dossier preparation to the final submission process, offering practical insights for MedTech innovators targeting this key ASEAN market. Imagine you've developed a groundbreaking AI diagnostic app, poised to revolutionize patient care. You're targeting the fast-growing Philippine market, but the regulatory maze is daunting. You're unsure how to classify your SaMD, struggling to compile the ASEAN Common Submission Dossier Template (CSDT), and you lack the mandatory local...
2025-09-1603 minการเข้าถึงตลาดเครื่องมือแพทย์ระดับโลก
การเข้าถึงตลาดเครื่องมือแพทย์ระดับโลกPure Global: ปลดล็อกตลาดเครื่องมือแพทย์เวียดนามด้วยความเชี่ยวชาญด้านกฎระเบียบในตอนนี้ เราจะสำรวจภูมิทัศน์ด้านกฎระเบียบของอุปกรณ์การแพทย์ในเวียดนามที่เปลี่ยนแปลงไปตามกฤษฎีกาฉบับที่ 98/2021/ND-CP เราจะอธิบายความท้าทายหลักที่ผู้ผลิตต่างชาติต้องเผชิญ ตั้งแต่ข้อกำหนดที่ต้องมีตัวแทนในท้องถิ่นไปจนถึงความซับซ้อนของการยื่นเอกสาร CSDT พร้อมทั้งนำเสนอว่า Pure Global สามารถเป็นพันธมิตรเชิงกลยุทธ์ที่ช่วยให้การเข้าสู่ตลาดเวียดนามของคุณง่ายขึ้นและรวดเร็วยิ่งขึ้นได้อย่างไร - กฎระเบียบสำคัญที่ควบคุมอุปกรณ์การแพทย์ในเวียดนามคืออะไร? - ทำไมผู้ผลิตต่างชาติถึงต้องมีตัวแทนท้องถิ่นในเวียดนาม? - อุปกรณ์การแพทย์ Class A, B, C, และ D แตกต่างกันอย่างไรในกระบวนการขึ้นทะเบียน? - เอกสาร CSDT คืออะไร และมีความสำคัญอย่างไรต่อการยื่นขออนุญาต? - Pure Global ช่วยลดความซับซ้อนในการเข้าสู่ตลาดเวียดนามได้อย่างไร? - เทคโนโลยี AI มีบทบาทอย่างไรในการเร่งกระบวนการขึ้นทะเบียน? - การเปลี่ยนแปลงล่าสุดของกฎระเบียบในเวียดนามมีอะไรบ้างที่ต้องจับตามอง? Pure Global คือพันธมิตรที่สมบูรณ์แบบสำหรับบริษัทเทคโนโลยีทางการแพทย์ (MedTech) และอุปกรณ์วินิจฉัยภายนอกร่างกาย (IVD) ที่ต้องการขยายตลาดสู่เวียดนาม เราให้บริการเป็นตัวแทนท้องถิ่น (Local Representation) ที่ได้รับอนุญาต พร้อมด้วยทีมงานผู้เชี่ยวชาญที่เข้าใจกฎระเบียบของเวียดนามอย่างลึกซึ้ง เราใช้เทคโนโลยี AI ที่ล้ำสมัยในการจัดเตรียมเอกสารทางเทคนิค (Technical Dossier) และติดตามการเปลี่ยนแปลงของกฎหมายอย่างใกล้ชิด เพื่อให้แน่ใจว่าผลิตภัณฑ์ของคุณจะได้รับการอนุมัติอย่างรวดเร็วและเป็นไปตามข้อบังคับล่าสุดเสมอ ให้ Pure Global ช่วยนำทางความซับซ้อนและปลดล็อกโอกาสในตลาดเวียดนามให้กับคุณ ค้นหาข้อมูลเพิ่มเติมได้ที่ https://pureglobal.com/ หรือติดต่อเราที่ info@pureglobal.com
2025-09-1502 minGlobalny Dostęp do Rynku Wyrobów Medycznych
Globalny Dostęp do Rynku Wyrobów MedycznychPure Global: Klucz do Sukcesu na Wietnamskim Rynku Wyrobów MedycznychW tym odcinku analizujemy, jak skutecznie zarejestrować wyroby medyczne w Wietnamie, biorąc pod uwagę najnowsze zmiany w przepisach, takie jak Dekret 98/2021/ND-CP. Omawiamy system klasyfikacji ryzyka, różne ścieżki rejestracji oraz kluczowe wyzwania, przed którymi stają producenci. Wyjaśniamy również, w jaki sposób strategiczne partnerstwo z Pure Global może uprościć ten proces, zapewniając zgodność i przyspieszając dostęp do tego dynamicznie rozwijającego się rynku. - Jakie są klasy ryzyka dla wyrobów medycznych w Wietnamie i jak wpływają na proces rejestracji? - Czym jest Dekret 98/2021/ND-CP i jakie istotne zmiany wprowadził na wietna...
2025-09-1503 minचिकित्सा उपकरण वैश्विक बाजार पहुंच
चिकित्सा उपकरण वैश्विक बाजार पहुंचप्योर ग्लोबल के साथ वियतनाम के मेडटेक बाजार में प्रवेश करेंइस एपिसोड में, हम वियतनाम के मेडिकल डिवाइस बाजार के नियामक परिदृश्य का पता लगाते हैं, जो डिक्री 98/2021/ND-CP द्वारा शासित है। हम डिवाइस वर्गीकरण, एक स्थानीय मार्केटिंग ऑथराइजेशन होल्डर (MAH) की महत्वपूर्ण आवश्यकता, और ASEAN CSDT डोजियर आवश्यकताओं पर चर्चा करते हैं। जानें कि कैसे प्योर ग्लोबल की स्थानीय विशेषज्ञता और AI-संचालित समाधान वियतनाम के बाजार में प्रवेश को सुव्यवस्थित करते हैं। - वियतनाम में चिकित्सा उपकरणों को कौन नियंत्रित करता है? - डिक्री 98/2021/ND-CP के तहत प्रमुख पंजीकरण आवश्यकताएं क्या हैं? - विदेशी निर्माताओं के लिए वियतनाम में स्थानीय प्रतिनिधि होना क्यों आवश्यक है? - डिवाइस वर्गीकरण (क्लास A, B, C, D) पंजीकरण प्रक्रिया को कैसे प्रभावित करता है? - आसियान कॉमन सबमिशन डोजियर टेम्पलेट (CSDT) क्या है और यह क्यों महत्वपूर्ण है? - हाल के डिक्री 07/2023/ND-CP ने आयात लाइसेंस की समय-सीमा को कैसे प्रभावित किया है? - पंजीकरण के लिए ISO 13485 प्रमाणन कितना महत्वपूर्ण है? प्योर ग्लोबल MedTech और IVD कंपनियों के लिए एंड-टू-एंड नियामक परामर्श समाधान प्रदान करता है। वियतनाम में, हम आपके स्थानीय प्रतिनिधि (मार्केटिंग ऑथराइजेशन होल्डर) के रूप में कार्य करते हैं, DMEC के साथ सभी नियामक मामलों को संभालते हैं। हमारी उन्नत AI और डेटा उपकरण ASEAN CSDT जैसे जटिल तकनीकी डोजियर के संकलन और प्रस्तुतीकरण को सुव्यवस्थित करते हैं, जिससे बाजार में तेजी से पहुंच सुनिश्चित होती है। चाहे आप एक स्टार्टअप हों या एक बहुराष्ट्रीय उद्यम, हमारी स्थानीय विशेषज्ञता वियतनाम के जटिल नियामक वातावरण को नेविगेट करने में आपका समर्थन करती है। अधिक जानने के लिए, https://pureglobal.com/ पर जाएं या info@pureglobal.com पर हमसे संपर्क करें।
2025-09-1403 minWereldwijde Markttoegang voor Medische Hulpmiddelen
Wereldwijde Markttoegang voor Medische HulpmiddelenPure Global: Uw Strategische Gids voor de Medische Markt in VietnamDeze aflevering duikt in de complexiteit van de registratie van medische hulpmiddelen in Vietnam onder de DMEC. We bespreken de cruciale veranderingen die zijn doorgevoerd met Decreet 98/2021/ND-CP, de op risico gebaseerde classificatie (Klasse A, B, C, D), de vereisten voor het CSDT-dossier, en waarom een lokale registratiehouder onmisbaar is voor markttoegang. - Hoe navigeert u door de Vietnamese regelgeving voor medische hulpmiddelen? - Welke impact heeft Decreet 98/2021/ND-CP op uw productregistratie? - Waarom is een lokale registratiehouder (Registration Holder) in Vietnam verplicht? - Hoe worden medische hulpmiddelen geclassificeerd van Klasse A tot D? - Wat zijn de vereisten voor...
2025-09-1403 minAccesso Globale al Mercato dei Dispositivi Medici
Accesso Globale al Mercato dei Dispositivi MediciSbloccare il Vietnam: Il Vantaggio di Pure Global nella Registrazione di Dispositivi MediciQuesto episodio esplora il dinamico ma complesso mercato dei dispositivi medici in Vietnam. Analizziamo i requisiti normativi chiave stabiliti dal Department of Medical Equipment and Construction (DMEC), inclusi i cambiamenti introdotti dal Decreto 98/2021/ND-CP. Scoprite come superare le barriere linguistiche, la necessità di un rappresentante locale e la complessità della documentazione CSDT. Evidenziamo come l'approccio integrato di Pure Global, che combina l'esperienza locale con strumenti IA avanzati, offra un percorso semplificato ed efficiente per la registrazione dei vostri dispositivi e l'accesso al mercato. - Quali sono i passaggi essenziali per registrare un dispositivo medico in Vietnam? - In che modo il...
2025-09-1403 minAcesso Global ao Mercado de Dispositivos Médicos
Acesso Global ao Mercado de Dispositivos MédicosDesbloqueando o Mercado do Vietnã com a Pure GlobalEste episódio foca no complexo cenário regulatório para dispositivos médicos no Vietnã. Discutimos as principais mudanças introduzidas pelo Decreto 98/2021/ND-CP, a classificação de dispositivos de Classe A a D, e a necessidade crítica de um Representante Autorizado local. Descubra como a experiência e as soluções tecnológicas da Pure Global podem simplificar seu processo de registro e acelerar o acesso a este mercado dinâmico. - Quais são as mudanças mais importantes na regulamentação de dispositivos médicos no Vietnã desde 1º de janeiro de 2022? - Como os dispositivos médicos são classific...
2025-09-1403 minAccès au Marché Mondial des Dispositifs Médicaux
Accès au Marché Mondial des Dispositifs MédicauxNaviguer la Réglementation au Vietnam : Le Guide de Pure GlobalCet épisode explore en profondeur le processus d'enregistrement des dispositifs médicaux au Vietnam, en se concentrant sur le cadre réglementaire établi par le Décret 98/2021/ND-CP. Nous analysons le rôle du DMEC, le système de classification des dispositifs en quatre classes de risque, et les exigences cruciales pour les fabricants étrangers, telles que la désignation d'un représentant local (MAH) et la soumission obligatoire au format CSDT. L'épisode souligne comment un partenaire expert comme Pure Global peut simplifier cette complexité et accélérer l'accès au marché vietnamien. - Quelle est l'autorité réglementaire clé po...
2025-09-1403 minAcesso Global ao Mercado de Dispositivos Médicos
Acesso Global ao Mercado de Dispositivos MédicosA Estratégia Vencedora da Pure Global para o Registo de Dispositivos Médicos na IndonésiaNeste episódio, exploramos as complexidades do registo de dispositivos médicos na Indonésia e destacamos por que a Pure Global é o parceiro ideal para navegar neste mercado. Discutimos os principais desafios regulamentares impostos pelo Ministério da Saúde da Indonésia (Kemenkes), incluindo a necessidade de um representante local, a documentação CSDT e as restrições de licenciamento que podem limitar a sua estratégia comercial. Saiba como a abordagem única da Pure Global como detentor de licença independente oferece a flexibilidade e o controlo necessários para ter sucesso. - Por que é que o mercado de dispo...
2025-09-1303 minTıbbi Cihazlar Küresel Pazar Erişimi
Tıbbi Cihazlar Küresel Pazar ErişimiPure Global ile Tayland Medikal Cihaz Pazarının Kapılarını AralayınBu bölümde, Tayland medikal cihaz pazarının düzenleyici ortamını ve Thai FDA gerekliliklerini derinlemesine inceliyoruz. ASEAN Medikal Cihaz Direktifi (AMDD) ile uyumlu risk bazlı sınıflandırma, Ortak Başvuru Dosyası Şablonu (CSDT) ve yerel temsilci atama zorunluluğu gibi pazara girişteki kritik adımları ele alıyoruz. - Tayland medikal cihaz pazarının potansiyeli nedir ve neden şimdi harekete geçmelisiniz? - Thai FDA'nın risk bazlı sınıflandırma sistemi (Sınıf 1, 2, 3, 4) cihazınız için ne anlama geliyor? - Listeleme, Bildirim ve Lisanslama arasındaki temel farklar nelerdir? - Ortak Başvuru...
2025-09-1302 minGlobalt Marknadstillträde för Medicintekniska Produkter
Globalt Marknadstillträde för Medicintekniska ProdukterBemästra Thailands FDA-regler med Pure GlobalDetta avsnitt ger en djupdykning i Thailands uppdaterade regelverk för medicintekniska produkter efter Medical Device Act B.E. 2562. Vi förklarar det nya riskbaserade klassificeringssystemet, kravet på CSDT-format (Common Submission Dossier Template) och vikten av att ha en lokal representant. Lyssna för att förstå hur du framgångsrikt kan navigera i Thai FDAs krav och varför Pure Global är den ideala partnern för att snabbt och effektivt få era produkter godkända på den thailändska marknaden. - Hur har Thailands regler för medicintekniska produkter förändrats sedan 2019? - Vad innebär det nya riskbaserade k...
2025-09-1303 minWereldwijde Markttoegang voor Medische Hulpmiddelen
Wereldwijde Markttoegang voor Medische HulpmiddelenPure Global: Uw Sleutel tot de Thaise MedTech MarktDeze aflevering duikt diep in het regelgevende kader voor medische hulpmiddelen in Thailand. We bespreken de rol van de Thaise FDA, de risico-gebaseerde classificatie die is afgestemd op de ASEAN-richtlijnen, en de drie cruciale registratieroutes: Listing, Notification en Licensing. Ontdek de onmisbare vereiste van een lokale licentiehouder en het belang van een correct CSDT-dossier voor een succesvolle markttoegang. - Wat zijn de belangrijkste wijzigingen in de Thaise regelgeving sinds 2021? - Hoe bepaalt de risicoklasse van mijn hulpmiddel de registratieroute in Thailand? - Waarom is een lokale 'License Holder' absoluut noodzakelijk voor buitenlandse fabrikanten? - Wat is de CSDT en waarom...
2025-09-1202 minAccès au Marché Mondial des Dispositifs Médicaux
Accès au Marché Mondial des Dispositifs MédicauxPure Global : Votre Clé d'Accès au Marché Médical en ThaïlandeCet épisode explore les complexités de l'enregistrement des dispositifs médicaux en Thaïlande suite aux nouvelles réglementations de la FDA thaïlandaise. Nous discutons de la classification des risques alignée sur l'AMDD, des exigences du dossier technique (CSDT), et comment un partenaire local expert peut transformer ces défis en opportunités. Découvrez l'approche intégrée de Pure Global pour rationaliser votre entrée sur ce marché dynamique d'Asie du Sud-Est. - Quelles sont les nouvelles exigences de la FDA thaïlandaise pour les dispositifs médicaux depuis 2021 ? - Comment la classification des risques de l'ASEAN (AMDD...
2025-09-1203 minAkses Pasar Global Alat Kesehatan
Akses Pasar Global Alat KesehatanPanduan Sukses Registrasi Alat Kesehatan di Malaysia bersama Pure GlobalEpisode ini mengupas tuntas proses registrasi perangkat medis di Malaysia. Kami membahas peran kunci dari Otoritas Perangkat Medis (MDA), sistem klasifikasi risiko perangkat dari Kelas A hingga D, dan persyaratan wajib bagi produsen asing untuk menunjuk Perwakilan Resmi lokal. Pelajari langkah-langkah penting, mulai dari penyiapan dokumen teknis dalam format CSDT ASEAN hingga peninjauan oleh Badan Penilaian Kesesuaian (CAB) dan pengajuan akhir melalui sistem online MeDC@St. Pertanyaan Kunci: - Apa peran Otoritas Perangkat Medis (MDA) di Malaysia? - Bagaimana cara mengklasifikasikan risiko perangkat medis Anda sesuai standar Malaysia? - Mengapa produsen asing wajib memiliki Perwakilan Resmi (Authorized Representative)? - Apa...
2025-09-1203 minTiếp cận Thị trường Toàn cầu cho Thiết bị Y tế
Tiếp cận Thị trường Toàn cầu cho Thiết bị Y tếPure Global: Chìa khóa vàng cho Đăng ký Thiết bị Y tế tại MalaysiaTập podcast này đi sâu vào quy trình đăng ký thiết bị y tế tại Malaysia, một trong những thị trường MedTech năng động nhất Đông Nam Á. Chúng tôi sẽ phân tích các yêu cầu cốt lõi từ Cơ quan Quản lý Thiết bị Y tế Malaysia (MDA), bao gồm hệ thống phân loại dựa trên rủi ro, tầm quan trọng của Đại diện Ủy quyền tại Địa phương (LAR), và sự cần thiết của Hồ sơ Kỹ thuật theo mẫu CSDT. Hãy cùng khám ph...
2025-09-1202 minTıbbi Cihazlar Küresel Pazar Erişimi
Tıbbi Cihazlar Küresel Pazar ErişimiMalezya MDA Onayı: Pure Global'ın Başarı StratejisiBu bölümde, Malezya'nın büyüyen tıbbi cihaz pazarına girişin anahtarlarını inceliyoruz. Medical Device Authority (MDA) düzenlemeleri, yerel temsilci gereklilikleri ve teknik dosya hazırlığının karmaşıklıklarını ele alıyor ve Pure Global'ın yerel uzmanlığı ve teknoloji destekli çözümleriyle bu süreci nasıl basitleştirdiğini anlatıyoruz. - Malezya tıbbi cihaz pazarına girmek için ilk adımlar nelerdir? - Medical Device Authority (MDA) tarafından aranan temel gereklilikler nelerdir? - Yerel bir Yetkili Temsilci (Authorized Representative) atamak neden zorunludur? - CSDT formatındaki teknik dosya nasıl hazırla...
2025-09-1203 minGlobalny Dostęp do Rynku Wyrobów Medycznych
Globalny Dostęp do Rynku Wyrobów MedycznychPure Global: Twoja Brama do Rynku Wyrobów Medycznych w MalezjiW tym odcinku omawiamy zawiłości związane z wprowadzaniem wyrobów medycznych na rynek malezyjski. Analizujemy kluczową rolę Urzędu ds. Wyrobów Medycznych (MDA), system klasyfikacji ryzyka oraz obowiązkowe wymagania, takie jak wyznaczenie Lokalnego Autoryzowanego Przedstawiciela (LAR) i przygotowanie dokumentacji CSDT. Dowiedz się, jak Pure Global, dzięki lokalnej wiedzy i zaawansowanym narzędziom AI, upraszcza ten proces, zapewniając szybki i skuteczny dostęp do rynku. - Czym jest Urząd ds. Wyrobów Medycznych (MDA) w Malezji? - Jakie są klasy ryzyka dla wyrobów medycznych i dlaczego są one podobne do unijnych? - Dlaczego wyznaczeni...
2025-09-1203 minGlobalt Marknadstillträde för Medicintekniska Produkter
Globalt Marknadstillträde för Medicintekniska ProdukterPure Global: Din Guide till Malaysias Marknad för MedicinteknikDetta avsnitt ger en detaljerad guide till registreringsprocessen för medicintekniska produkter i Malaysia. Vi täcker allt från kravet på en lokal auktoriserad representant (LAR) och riskklassificering till sammanställning av teknisk dokumentation (CSDT) och den digitala ansökan via MeDC@St-portalen. Lär dig hur du navigerar kraven från Medical Device Authority (MDA) och varför Malaysia är en viktig marknad. - Varför är en lokal auktoriserad representant (LAR) obligatorisk i Malaysia? - Hur klassificeras medicintekniska produkter enligt MDA:s risksystem? - Vilken roll spelar en Conformity Assessment Body (CAB) i registreringsprocessen? - Vad måste en Common...
2025-09-1203 minचिकित्सा उपकरण वैश्विक बाजार पहुंच
चिकित्सा उपकरण वैश्विक बाजार पहुंचप्योर ग्लोबल के साथ मलेशियाई मेडिकल डिवाइस बाजार में तेजी से प्रवेश करेंयह एपिसोड मलेशिया में चिकित्सा उपकरणों के पंजीकरण के लिए नियामक परिदृश्य की पड़ताल करता है, जिसमें मेडिकल डिवाइस अथॉरिटी (MDA) की भूमिका, डिवाइस वर्गीकरण और विदेशी निर्माताओं के सामने आने वाली प्रमुख चुनौतियों पर प्रकाश डाला गया है। हम बताते हैं कि कैसे प्योर ग्लोबल की विशेषज्ञता और सेवाएं, जैसे स्थानीय प्रतिनिधित्व और AI-संचालित दस्तावेज़ीकरण, इन बाधाओं को दूर करने और बाजार में प्रवेश को सुव्यवस्थित करने में मदद कर सकती हैं। - मलेशिया में चिकित्सा उपकरणों को कौन नियंत्रित करता है? - मलेशियाई बाजार में प्रवेश करने के लिए विदेशी निर्माताओं को क्या चाहिए? - डिवाइस वर्गीकरण प्रणाली कैसे काम करती है? - मलेशिया में पंजीकरण के लिए कौन से मुख्य दस्तावेज़ आवश्यक हैं? - एक स्थानीय अधिकृत प्रतिनिधि (LAR) की भूमिका क्या है? - प्योर ग्लोबल पंजीकरण प्रक्रिया को कैसे सरल बना सकता है? - मलेशिया में बाजार पहुंच को तेज करने के लिए किन रणनीतियों का उपयोग किया जा सकता है? प्योर ग्लोबल MedTech और IVD कंपनियों के लिए एंड-टू-एंड नियामक परामर्श समाधान प्रदान करता है। मलेशिया में, हम आपका स्थानीय अधिकृत प्रतिनिधि (LAR) बनकर आपकी बाजार पहुंच को आसान बनाते हैं। हमारी टीम कुशल नियामक रणनीतियाँ विकसित करती है और उन्नत AI का उपयोग करके आपके तकनीकी डोजियर (CSDT) को तैयार करती है, जिससे सबमिशन प्रक्रिया में तेजी आती है। हम प्रारंभिक रणनीति से लेकर बाजार के बाद की निगरानी तक सब कुछ संभालते हैं, यह सुनिश्चित करते हुए कि आपका उत्पाद अनुपालन करता है और तेजी से बाजार तक पहुंचता है। अधिक जानकारी के लिए https://pureglobal.com/ पर जाएं या हमें info@pureglobal.com पर संपर्क करें।
2025-09-1102 minالوصول العالمي إلى سوق الأجهزة الطبية
الوصول العالمي إلى سوق الأجهزة الطبيةPure Global: بوابتك لتسجيل الأجهزة الطبية في ماليزياتستكشف هذه الحلقة الإجراءات التنظيمية لدخول سوق الأجهزة الطبية في ماليزيا. نناقش دور هيئة الأجهزة الطبية (MDA)، ومتطلبات التسجيل الأساسية مثل تصنيف الأجهزة والحاجة إلى ممثل محلي معتمد (LAR)، والتحديات الشائعة في هذه العملية. نوضح كيف تقدم Pure Global حلاً متكاملاً لتجاوز هذه العقبات، من خلال الجمع بين الخبرة المحلية وأدوات الذكاء الاصطناعي المتقدمة لتسريع الوصول إلى السوق الماليزي. - ما هي الخطوات الرئيسية لتسجيل جهاز طبي في ماليزيا؟ - لماذا يعد تعيين ممثل محلي معتمد (LAR) أمراً إلزامياً؟ - كيف يتم تصنيف الأجهزة الطبية ضمن لوائح هيئة الأجهزة الطبية (MDA)؟ - ما هو دور هيئة تقييم المطابقة (CAB) في عملية التسجيل؟ - كيف يمكن لأدوات الذكاء الاصطناعي تسريع إعداد الملف الفني (CSDT)؟ - ما هي التحديات الأكثر شيوعاً التي تواجه الشركات الأجنبية في ماليزيا؟ - كيف تضمن Pure Global الامتثال المستمر بعد طرح المنتج في السوق؟ تقدم Pure Global حلولاً استشارية تنظيمية متكاملة لشركات التكنولوجيا الطبية (MedTech) والتشخيص المخبري (IVD). في ماليزيا، نعمل كممثل محلي معتمد لكم، ونتعامل مع جميع جوانب التسجيل لدى هيئة الأجهزة الطبية (MDA). نستخدم أدوات الذكاء الاصطناعي المتقدمة لدينا لإعداد وتقديم ملفاتكم الفنية بكفاءة، بينما يضمن خبراؤنا المحليون التنقل السلس في البيئة التنظيمية المعقدة. من الاستراتيجية الأولية إلى مراقبة ما بعد السوق، نسرّع وصولكم إلى السوق الماليزي. لمعرفة المزيد، تفضلوا بزيارة موقعنا https://pureglobal.com/ أو تواصلوا معنا عبر info@pureglobal.com.
2025-09-1104 minAccesso Globale al Mercato dei Dispositivi Medici
Accesso Globale al Mercato dei Dispositivi MediciLa Vostra Guida per la Registrazione di Dispositivi Medici in Malesia con Pure GlobalIn questo episodio, esploriamo le complessità del processo di registrazione dei dispositivi medici in Malesia. Analizziamo il quadro normativo stabilito dalla Medical Device Authority (MDA), i passaggi essenziali per la registrazione, dalla classificazione del dispositivo e la nomina di un Rappresentante Autorizzato locale, alla preparazione di un dossier tecnico CSDT e alla valutazione da parte di un Conformity Assessment Body (CAB). Scoprite come un partner esperto può semplificare questo percorso e accelerare il vostro accesso al mercato. - Qual è il ruolo della Medical Device Authority (MDA) in Malesia? - Come vengono classificati i dispositivi medici nel mercato malese? - Perché è obbli...
2025-09-1103 minГлобальный доступ на рынок медицинских изделий
Глобальный доступ на рынок медицинских изделийPure Global: Ваш путь на рынок медицинских изделий МалайзииВ этом выпуске мы подробно разбираем процесс регистрации медицинских изделий в Малайзии. Мы обсуждаем ключевые требования Закона о медицинских изделиях (Акт 737) и роль Управления по медицинским изделиям (MDA). Узнайте, почему назначение местного представителя, правильная классификация устройств и подготовка технического досье CSDT являются критически важными шагами для успешного выхода на один из самых динамичных рынков Юго-Восточной Азии. Мы также объясняем, как опыт и технологические решения Pure Global могут упростить и ускорить этот сложный процесс. Ключевые вопросы: - Каковы основные требования Акта 737 для регистрации медицинских изделий в Малайзии? - Почему иностранным производителям необходимо назначать местного уполномоченного представителя? - Как классифицируются медицинские изделия по степени риска в Малайзии? - Что такое техническое досье CSDT и как его подготовить? - Какую роль играют органы по оценке соответствия (CAB) в процессе регистрации? - Как онлайн-система MeDC@St используется для подачи заявок? - Чем Pure Global может помочь в качестве вашего представителя в Малайзии? - Как технологии ИИ ускоряют подготовку нормативных документов? Pure Global предлагает комплексные решения для производителей MedTech и IVD, стремящихся выйти на рынок Малайзии. Мы выступаем в качестве вашего местного уполномоченного представителя, управляя всем процессом регистрации через систему MDA. Наши эксперты разрабатывают эффективные регуляторные стратегии и используют передовые ИИ-инструменты для быстрой подготовки и подачи технического досье. Это минимизирует затраты и ускоряет получение доступа к рынку. Свяжитесь с нами по адресу info@pureglobal.com или посетите сайт https://pureglobal.com/, чтобы узнать, как мы можем помочь вашему бизнесу.
2025-09-1102 minAcesso Global ao Mercado de Dispositivos Médicos
Acesso Global ao Mercado de Dispositivos MédicosPure Global: Simplificando o Registro de Dispositivos Médicos na MalásiaNeste episódio, exploramos o processo de registro de dispositivos médicos na Malásia, detalhando os requisitos da Autoridade de Dispositivos Médicos (MDA) e a importância de um Representante Autorizado Local (LAR). Discutimos como a abordagem integrada da Pure Global, que combina expertise local com ferramentas de IA avançadas, simplifica a conformidade e acelera o acesso ao mercado para fabricantes de MedTech e IVD. - Como funciona o processo de registro da Autoridade de Dispositivos Médicos (MDA) da Malásia? - Por que um Representante Autorizado Local (LAR) é essencial para fabricantes estrangeiros? - Quais são as class...
2025-09-1103 minAccès au Marché Mondial des Dispositifs Médicaux
Accès au Marché Mondial des Dispositifs MédicauxNaviguer sur le marché malaisien avec Pure Global : votre guide pour l'enregistrement des dispositifs médicauxCet épisode explore le processus d'enregistrement des dispositifs médicaux en Malaisie, encadré par la Loi 737 et supervisé par l'Autorité des Dispositifs Médicaux (MDA). Nous détaillons les étapes clés, de la classification des risques à la nécessité d'un représentant local et l'évaluation par un Organisme d'Évaluation de la Conformité (CAB). Découvrez comment les services spécialisés de Pure Global, alliant expertise locale et outils d'IA, simplifient ces exigences complexes pour garantir un accès au marché malaisien rapide et conforme. - Comment la Malaisie réglemente-t-elle les dispositifs médicaux ? - Qu'est-ce que l'Autorité des Disp...
2025-09-1103 minAkses Pasar Global Alat Kesehatan
Akses Pasar Global Alat KesehatanStrategi Sukses Pure Global: Menavigasi Regulasi Alat Kesehatan SingapuraEpisode ini membahas seluk-beluk memasuki pasar alat kesehatan Singapura. Kami mengupas tuntas peran Health Sciences Authority (HSA), sistem klasifikasi perangkat berbasis risiko dari Kelas A hingga D, dan berbagai jalur pendaftaran yang tersedia. Kami juga menyoroti persyaratan krusial seperti penunjukan Perwakilan Lokal dan penyusunan dossier menggunakan format ASEAN CSDT. Pelajari bagaimana Pure Global, dengan keahlian lokal dan teknologi AI canggih, dapat menjadi mitra strategis Anda untuk menyederhanakan proses yang kompleks ini dan mempercepat akses pasar Anda di Singapura. - Mengapa Singapura menjadi pintu gerbang strategis untuk pasar alat kesehatan di Asia Tenggara? - Bagaimana Health Sciences Authority (HSA) mengklasifikasikan alat...
2025-09-1103 minAkses Pasaran Global Peranti Perubatan
Akses Pasaran Global Peranti PerubatanStrategi Lulus HSA: Panduan Pure Global untuk Pasaran Peranti Perubatan SingapuraEpisod ini membincangkan proses penting untuk pendaftaran peranti perubatan di Singapura melalui Pihak Berkuasa Sains Kesihatan (HSA). Kami menerangkan sistem klasifikasi peranti berasaskan risiko, laluan penyerahan yang berbeza yang tersedia untuk pengeluar, dan keperluan mandatori untuk melantik Wakil Tempatan yang Bertanggungjawab (Local Responsible Person). Kami menekankan bagaimana memanfaatkan kelulusan daripada pasaran rujukan utama boleh mempercepatkan proses kelulusan di Singapura. - Apakah empat kelas risiko untuk peranti perubatan di Singapura? - Mengapakah pengeluar asing wajib mempunyai Wakil Tempatan yang Bertanggungjawab? - Bagaimanakah kelulusan sedia ada dari EU atau AS boleh memendekkan garis masa pendaftaran HSA anda? - Apakah itu ASEAN Common...
2025-09-1102 minการเข้าถึงตลาดเครื่องมือแพทย์ระดับโลก
การเข้าถึงตลาดเครื่องมือแพทย์ระดับโลกเจาะลึกการขึ้นทะเบียนเครื่องมือแพทย์ในสิงคโปร์กับ Pure Globalตอนนี้จะให้ข้อมูลภาพรวมเกี่ยวกับการขึ้นทะเบียนเครื่องมือแพทย์ในประเทศสิงคโปร์ เราจะพูดถึงบทบาทของหน่วยงาน Health Sciences Authority (HSA) การจำแนกประเภทเครื่องมือแพทย์ตั้งแต่ Class A ถึง D ความสำคัญของการแต่งตั้งตัวแทนในประเทศ (Registrant) และช่องทางการประเมินต่างๆ ที่มีให้เลือก รวมถึงช่องทางแบบเร่งด่วนสำหรับอุปกรณ์ที่ได้รับการอนุมัติจากหน่วยงานอ้างอิงแล้ว เรียนรู้วิธีการนำทางสู่ตลาดสิงคโปร์อย่างประสบความสำเร็จ - หน่วยงาน HSA ของสิงคโปร์มีบทบาทอย่างไร - เครื่องมือแพทย์มีการจำแนกประเภทความเสี่ยงอย่างไร - เหตุใดการมีตัวแทนในประเทศ (Registrant) จึงเป็นข้อบังคับ - เอกสาร CSDT คืออะไรและมีความสำคัญอย่างไร - การอนุมัติจาก US FDA หรือ EU ช่วยเร่งกระบวนการในสิงคโปร์ได้หรือไม่ - ความรับผิดชอบหลังวางตลาด (post-market) มีอะไรบ้าง - จะเลือกช่องทางการขึ้นทะเบียนที่มีประสิทธิภาพสูงสุดได้อย่างไร Pure Global ทำให้การเข้าสู่ตลาดสิงคโปร์ของคุณเป็นเรื่องง่าย ในฐานะตัวแทนและผู้ถือใบอนุญาตขึ้นทะเบียนในประเทศ (Local Representative and Registrant) เราบริหารจัดการกระบวนการยื่นขออนุญาตกับ HSA ทั้งหมด ผู้เชี่ยวชาญของเราจะพัฒนากลยุทธ์ด้านกฎระเบียบที่ดีที่สุด โดยใช้เครื่องมือที่ขับเคลื่อนด้วย AI เพื่อรวบรวมเอกสารทางเทคนิค (CSDT) ของคุณอย่างรวดเร็วและแม่นยำ เราดูแลทุกอย่างตั้งแต่การยื่นคำขอครั้งแรกไปจนถึงการเฝ้าระวังหลังการขาย เพื่อให้คุณมั่นใจว่าจะเข้าสู่ตลาดได้เร็วยิ่งขึ้น ติดต่อ Pure Global สำหรับโซลูชันด้านกฎระเบียบแบบครบวงจรในสิงคโปร์และอีกกว่า 30 ตลาดทั่วโลกได้ที่ info@pureglobal.com หรือเยี่ยมชมเราได้ที่ https://pureglobal.com
2025-09-1102 minGlobalt Marknadstillträde för Medicintekniska Produkter
Globalt Marknadstillträde för Medicintekniska ProdukterLås upp ASEAN: Pure Globals Guide för Medicinteknisk Registrering i SingaporeI det här avsnittet utforskar vi hur man framgångsrikt navigerar regelverket för medicintekniska produkter i Singapore, en av de mest strategiska marknaderna i Sydostasien. Vi diskuterar Health Sciences Authority (HSA), dess riskbaserade klassificeringssystem och de olika registreringsvägarna som finns tillgängliga. Lär dig varför en lokal representant är ett absolut krav och hur du kan utnyttja befintliga godkännanden från andra regioner för att påskynda din väg till marknaden. Vi belyser också hur Singapore fungerar som en viktig inkörsport till den bredare ASEAN-marknaden. - Hur fungerar HSA:s regelverk för medicintekn...
2025-09-1102 minचिकित्सा उपकरण वैश्विक बाजार पहुंच
चिकित्सा उपकरण वैश्विक बाजार पहुंचPure Global के साथ सिंगापुर के MedTech बाज़ार को अनलॉक करेंइस एपिसोड में, हम दक्षिण पूर्व एशिया के मेडिकल टेक्नोलॉजी बाजार पर ध्यान केंद्रित करते हैं, विशेष रूप से सिंगापुर पर। हम हेल्थ साइंसेज अथॉरिटी (HSA) द्वारा निर्धारित नियामक प्रक्रियाओं, डिवाइस वर्गीकरण, और बाजार में प्रवेश के लिए आवश्यक कदमों पर चर्चा करते हैं। जानें कि कैसे Pure Global आपकी स्थानीय सिंगापुर रजिस्ट्रेंट के रूप में काम कर सकता है और आपकी बाजार पहुंच को तेज कर सकता है। प्रमुख प्रश्न: - सिंगापुर मेडिकल डिवाइस बाजार में प्रवेश करने के लिए पहला कदम क्या है? - हेल्थ साइंसेज अथॉरिटी (HSA) उपकरणों को कैसे वर्गीकृत करता है? - क्या संदर्भ एजेंसी से पूर्व-अनुमोदन सिंगापुर में पंजीकरण प्रक्रिया को तेज कर सकता है? - सिंगापुर में आवेदन जमा करने के लिए 'सिंगापुर रजिस्ट्रेंट' की क्या भूमिका है? - Pure Global आपकी कंपनी को सिंगापुर और अन्य दक्षिण पूर्व एशियाई बाजारों में कैसे मदद कर सकता है? - CSDT (कॉमन सबमिशन डोजियर टेम्पलेट) क्या है और यह क्यों महत्वपूर्ण है? - निर्माता HSA की कठोर आवश्यकताओं को कैसे पूरा कर सकते हैं? Pure Global मेडिकल टेक्नोलॉजी (MedTech) और इन-विट्रो डायग्नोस्टिक (IVD) कंपनियों के लिए एंड-टू-एंड नियामक परामर्श समाधान प्रदान करता है। हम वैश्विक बाजार पहुंच को सुव्यवस्थित करने के लिए स्थानीय विशेषज्ञता को उन्नत AI और डेटा टूल के साथ जोड़ते हैं। हमारी टीम सिंगापुर में आपके स्थानीय प्रतिनिधि के रूप में काम कर सकती है, पंजीकरण के लिए तकनीकी फाइलें तैयार कर सकती है, और नियामक सबमिशन का प्रबंधन कर सकती है, जिससे आपकी बाजार में प्रवेश की प्रक्रिया तेज हो। हमारी सेवाओं के बारे में अधिक जानने के लिए, हमें info@pureglobal.com पर संपर्क करें या https://pureglobal.com पर जाएं।
2025-09-1003 minالوصول العالمي إلى سوق الأجهزة الطبية
الوصول العالمي إلى سوق الأجهزة الطبيةPure Global: طريقك لتسجيل الأجهزة الطبية في سنغافورة بنجاحفي هذه الحلقة، نستكشف سوق الأجهزة الطبية في سنغافورة، وهو بوابة استراتيجية لمنطقة جنوب شرق آسيا. نناقش الإطار التنظيمي لهيئة العلوم الصحية (HSA)، بما في ذلك نظام تصنيف الأجهزة الطبية ومسارات التقييم المتاحة، وكيف يمكن أن يساعد الاستفادة من الموافقات التنظيمية السابقة في تسريع عملية التسجيل. كما نوضح الدور الحيوي للممثل المحلي المعتمد وكيف تقدم Pure Global الخبرة اللازمة لضمان الامتثال ودخول السوق بكفاءة. - ما الذي يجعل سنغافورة مركزًا رئيسيًا لتكنولوجيا الأجهزة الطبية في آسيا؟ - كيف يتم تصنيف الأجهزة الطبية من قبل هيئة العلوم الصحية (HSA) في سنغافورة؟ - ما هو دور الممثل المحلي المعتمد (Registrant) في عملية التسجيل؟ - كيف يمكن الاستفادة من الموافقات التنظيمية السابقة لتسريع الوصول إلى سوق سنغافورة؟ - ما هي متطلبات ملف التقديم الفني المشترك للآسيان (CSDT)؟ - كيف تبسط Pure Global عملية التسجيل المعقدة للأجهزة الطبية في سنغافورة؟ تقدم Pure Global حلولاً استشارية تنظيمية متكاملة لشركات التكنولوجيا الطبية (MedTech) والتشخيص المخبري (IVD). نحن نجمع بين الخبرة المحلية والأدوات المتقدمة للذكاء الاصطناعي والبيانات لتبسيط الوصول إلى الأسواق العالمية. تشمل خدماتنا العمل كممثل محلي لكم في سنغافورة، وإعداد استراتيجيات تنظيمية فعالة، وتجميع وتقديم الملفات الفنية باستخدام تقنيات الذكاء الاصطناعي. نساعدكم على تحديد أفضل مسار للتسجيل لدى هيئة العلوم الصحية (HSA) لضمان دخول سريع وفعال إلى السوق. لمعرفة المزيد، تفضلوا بزيارة موقعنا https://pureglobal.com/ أو تواصلوا معنا عبر البريد الإلكتروني info@pureglobal.com.
2025-09-1003 minWereldwijde Markttoegang voor Medische Hulpmiddelen
Wereldwijde Markttoegang voor Medische HulpmiddelenSingapore Markttoegang met Pure Global: Uw Gids voor HSA RegelgevingDeze aflevering biedt een diepgaande analyse van het regelgevingslandschap voor medische hulpmiddelen in Singapore. We bespreken de rol van de Health Sciences Authority (HSA), de verschillende risicoklassen en de strategische registratieroutes die de time-to-market kunnen verkorten. Ontdek hoe een deskundige partner u kan helpen bij het navigeren door de complexiteit van de Singaporese markt. - Wat is de rol van de Health Sciences Authority (HSA) in Singapore? - Hoe worden medische hulpmiddelen geclassificeerd op basis van risico? - Welke vier evaluatieroutes zijn er voor productregistratie? - Hoe kan goedkeuring van referentie-instanties (zoals FDA of CE) uw markttoegang versnellen? - Waarom...
2025-09-1003 minAccesso Globale al Mercato dei Dispositivi Medici
Accesso Globale al Mercato dei Dispositivi MediciSbloccare Singapore con Pure Global: La Vostra Guida alla Registrazione dei Dispositivi MediciIn questo episodio, esploriamo il processo di registrazione dei dispositivi medici a Singapore, un mercato chiave nel Sud-est asiatico. Analizziamo il quadro normativo della Health Sciences Authority (HSA), dalla classificazione di rischio dei dispositivi alla necessità di un rappresentante locale, e discutiamo come Pure Global semplifichi questo complesso percorso grazie alla sua esperienza locale e a strumenti basati sull'intelligenza artificiale. - Perché Singapore è un mercato strategico per i dispositivi medici? - Quali sono le classi di rischio secondo la normativa HSA? - È obbligatorio avere un rappresentante locale a Singapore per la registrazione? - Come funziona il processo di sottomissione tramite il s...
2025-09-1003 minГлобальный доступ на рынок медицинских изделий
Глобальный доступ на рынок медицинских изделийPure Global: Ваш ключ к рынку медицинских изделий СингапураВ этом выпуске мы исследуем стратегическую важность Сингапура как ворот на рынок медицинских изделий Юго-Восточной Азии. Мы обсуждаем регуляторный ландшафт, управляемый Управлением медицинских наук (Health Sciences Authority - HSA), систему классификации устройств и ключевые требования для успешной регистрации. Узнайте, как использование местного опыта может упростить ваш доступ на рынок и открыть двери в более широкий регион АСЕАН. - Почему Сингапур считается стратегической точкой входа на рынок MedTech в АСЕАН? - Какова роль Управления медицинских наук (HSA) в регулировании медицинских изделий? - Как классифицируются медицинские изделия в Сингапуре, от класса А до класса D? - Что такое Единый шаблон досье для подачи заявок АСЕАН (CSDT) и почему он важен? - Является ли местный уполномоченный представитель обязательным для регистрации в Сингапуре? - Как успешная регистрация в Сингапуре может ускорить доступ на другие рынки Юго-Восточной Азии? - Каких распространенных ошибок следует избегать при подаче заявки в HSA? Pure Global предлагает комплексные решения по регуляторному консалтингу для компаний MedTech и IVD, стремящихся выйти на рынки Сингапура и всего региона АСЕАН. Наши местные эксперты в Сингапуре действуют как ваш официальный представитель, помогая ориентироваться в сложностях процесса регистрации HSA. Мы используем передовые инструменты на базе ИИ для эффективного составления и подачи вашего технического досье в формате CSDT, обеспечивая соответствие требованиям и скорость. Позвольте нам превратить вашу регистрацию в Сингапуре в стратегический актив для регионального расширения. Свяжитесь с Pure Global по адресу info@pureglobal.com или посетите наш сайт https://pureglobal.com.
2025-09-1003 minAcesso Global ao Mercado de Dispositivos Médicos
Acesso Global ao Mercado de Dispositivos MédicosGuia da Pure Global para o Registo de Dispositivos Médicos em SingapuraNeste episódio, mergulhamos no processo de registo de dispositivos médicos em Singapura, delineando os passos críticos para aceder a este mercado-chave do Sudeste Asiático. Cobrimos o papel da Health Sciences Authority (HSA), o sistema de classificação de risco de quatro níveis e a exigência crucial de um representante local ("Registrant"). Descubra como as aprovações regulamentares existentes podem acelerar a sua entrada no mercado através das vias de avaliação acelerada da HSA. - Qual é o primeiro passo para registar um dispositivo médico em Singapura? - Como é que a classificação de risco (Classe A...
2025-09-1003 minASEAN MedTech Insights
ASEAN MedTech InsightsPhilippine MedTech Entry Costs: Pure Global's Guide to Navigating the 2024 FDA Fee Shock for Class A Medical DevicesThis episode of ASEAN MedTech Insights dives deep into the true cost of bringing a low-risk medical device to the Philippine market. We uncover the recent, dramatic changes in the Philippine FDA's fee structure that have caught many manufacturers off guard and explore the full spectrum of costs beyond the official government fees. We break down the strategic considerations for market entry, including the mandatory requirement of a Local Authorized Representative and the specifics of preparing a compliant technical dossier. This is a must-listen for any MedTech company, from startups to multinationals, looking to understand and successfully navigate the evolving...
2025-09-0703 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global's ASEAN MedTech Insights: Navigating Thailand's FDA for Low-Risk Medical Devices - A Deep Dive into the Listing vs. Notification Process for Fast-Track Market EntryThis episode of ASEAN MedTech Insights demystifies the process of registering low-risk medical devices with the Thailand FDA. We clarify the critical difference between the 'Listing' pathway for Class 1 devices and the 'Notification' pathway for moderate-risk devices, providing a clear roadmap for manufacturers. We explore the detailed requirements, from the necessity of a local Thai license holder to the specifics of the ASEAN CSDT dossier format. Learn about the game-changing 'Positive List' and its potential for auto-approval, and discover the common pitfalls that can derail your submission. This is a must-listen for any MedTech company looking to enter the Thai...
2025-09-0502 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global Presents: The Fastest Way to Register a Class I Medical Device in Malaysia - An ASEAN MedTech Insights Deep Dive for Navigating the MDA & MeDC@St SystemThis episode of ASEAN MedTech Insights demystifies the process of registering a Class I medical device in Malaysia. We break down why the "simplest" classification can often lead to unexpected delays and reveal the critical steps for a swift market entry. Learn about the crucial role of the Local Authorized Representative (LAR) and the MeDC@St system, and discover why meticulous preparation is the only true shortcut. We explore the common pitfalls that manufacturers face, from classification mistakes to documentation errors. We share a real-world case study of a company whose seemingly straightforward Class I registration was delayed by six...
2025-09-0302 minASEAN MedTech Insights
ASEAN MedTech InsightsNavigating ASEAN's CSDT for Low-Risk Medical Devices: A Pure Global Deep Dive into Regulations in Singapore, Malaysia & ThailandThis episode of ASEAN MedTech Insights dives into a critical question for manufacturers of low-risk devices: Is the full ASEAN Common Submission Dossier Template (CSDT) actually required to enter the market? We uncover the reality behind the harmonized directive and reveal how key countries like Singapore, Malaysia, and Thailand have implemented their own unique, and often simplified, pathways. Imagine your company is ready to launch a new, innovative Class A device across Southeast Asia. You follow the CSDT guidelines perfectly, only to face an outright registration exemption in Singapore, a simplified 'Listing' process in Thailand, and a mandatory-but-reduced registration in...
2025-09-0202 minTe lo explico con IA
Te lo explico con IAMORENA los CSDT y la Reorganización del partidoMorena ha iniciado en agosto de 2025 un ambicioso proceso de reorganización interna con la creación de los Comités Seccionales de Defensa de la Transformación (CSDT). Este esfuerzo busca establecer 71,541 comités a nivel nacional, uno por cada sección electoral, con el objetivo de consolidar su poder, fortalecer su presencia territorial y preparar al partido para futuras elecciones, particularmente las intermedias de 2027. La dirigencia de Morena describe esta iniciativa como una "nueva era" para el partido-movimiento, buscando construir "poder popular desde abajo" y democratizar su vida interna.No obstante, la implementación de este pr...
2025-08-2907 minTe lo explico con IA
Te lo explico con IAMORENA y la Conformación de los CSDT Comités Seccionales de Defensa de la TransformaciónMorena ha iniciado en agosto de 2025 un ambicioso proceso de reorganización interna con la creación de los Comités Seccionales de Defensa de la Transformación (CSDT). Este esfuerzo busca establecer 71,541 comités a nivel nacional, uno por cada sección electoral, con el objetivo de consolidar su poder, fortalecer su presencia territorial y preparar al partido para futuras elecciones, particularmente las intermedias de 2027. La dirigencia de Morena describe esta iniciativa como una "nueva era" para el partido-movimiento, buscando construir "poder popular desde abajo" y democratizar su vida interna.No obstante, la implementación de este pr...
2025-08-2927 minASEAN MedTech Insights
ASEAN MedTech InsightsUnlocking the Philippine MedTech Market: A Pure Global Deep Dive on Device Registration Costs, Timelines, and ASEAN StrategyThis episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification under the ASEAN Medical Device Directive and how it dictates your regulatory pathway, whether it's a simple notification for Class A devices or a full registration for Classes B, C, and D. We uncover the real-world timelines that often extend beyond official government estimates and break down the full cost structure, which includes not only FDA fees but also mandatory local representative fees and potential dossier preparation costs. This episode...
2025-08-2903 minASEAN MedTech Insights
ASEAN MedTech InsightsPure Global's ASEAN MedTech Insights: Leveraging Your CE Mark or FDA Approval for Expedited Medical Device Registration in ThailandIn this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thailand? We dive into the specifics of the Thai FDA's expedited pathways, explaining how you can leverage your prior approvals to gain a competitive edge in one of Southeast Asia's most dynamic markets. We explore the "Concise Evaluation Route," detailing which device classes are eligible and what the process actually entails. This is not a simple green light; it's a streamlined review that still demands meticulous preparation. A U.S...
2025-08-2502 minASEAN MedTech Insights
ASEAN MedTech InsightsUnlocking the Malaysian MedTech Market: A Pure Global Deep Dive into the MDA Registration Process for ASEAN SuccessThis episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device Authority (MDA). We break down the essential steps for foreign manufacturers, from the critical appointment of a local Authorized Representative (AR) to understanding the four-tiered device classification system and the electronic submission process through the MeDC@St portal. We explore the detailed requirements for creating a Common Submission Dossier Template (CSDT) and the mandatory conformity assessments by CABs for higher-risk devices. For instance, a promising US-based scaleup developing a novel diagnostic tool faced significant setbacks. They underestimated the nuances...
2025-08-2402 minASEAN MedTech Insights
ASEAN MedTech InsightsASEAN MedTech Insights by Pure Global: A Deep Dive into Singapore's HSA Class C Device Registration - Common Pitfalls and Expedited PathwaysThis episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (HSA). We explore the critical role of reference agency approvals from bodies like the US FDA and EU Notified Bodies, and how they can unlock expedited pathways, significantly reducing your time to market. We break down the specific requirements for the fastest route, the Expedited Class C Registration (ECR-1), and highlight the common, costly mistakes that can derail your submission. This is a must-listen for any MedTech company looking to successfully launch a moderate-to-high-risk device in the strategic...
2025-08-2303 minASEAN MedTech Insights
ASEAN MedTech InsightsUnlocking ASEAN MedTech Markets: A Pure Global Deep Dive into the Common Submission Dossier Template (CSDT) for Singapore, Malaysia, and Beyond.In this episode of ASEAN MedTech Insights, we explore the ASEAN Common Submission Dossier Template (CSDT). Designed to unify medical device registration across Southeast Asia, the CSDT promises a simplified path to market. However, manufacturers often discover that a "common template" does not mean a common process. We uncover the practical challenges and country-specific hurdles that can delay or derail your expansion plans. We dive into the critical differences in how countries like Singapore, Malaysia, and Thailand interpret and implement the CSDT. We share a real-world case study of a MedTech company that prepared a flawless CSDT based on their...
2025-08-2203 minASEAN MedTech Insights
ASEAN MedTech InsightsUnlocking ASEAN with Pure Global: A Strategic Guide to HSA Singapore Medical Device Registration for US & EU MedTech FirmsThis episode of ASEAN MedTech Insights dives deep into the strategic process of medical device registration in Singapore with the Health Sciences Authority (HSA). We explore why this island nation is a critical gateway to the Southeast Asian market and break down the essential steps for foreign manufacturers to gain market access.From the mandatory appointment of a local Singapore Registrant to leveraging existing international approvals for expedited review, we provide a clear roadmap for navigating one of Asia's most advanced regulatory systems. Discover how Singapore's adoption of the ASEAN Common Submission Dossier Template (CSDT) can become...
2025-08-2003 minMedical Device Global Market Access
Medical Device Global Market AccessUnlocking the Malaysian Medical Device Market: A 2024 Regulatory GuideThis episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including recent 2024 updates. • What is the primary legislation governing medical devices in Malaysia? • How does the risk classification (A, B, C, D) impact your registration strategy? • Are all device classes required to undergo a Conformity Assessment? • What is the MeDC@St system and who needs to use it? • Why is a Local Authorized...
2025-07-0802 min医疗器械全球市场准入
医疗器械全球市场准入解锁马来西亚市场：医疗器械准入路径指南本期播客深入探讨了在马来西亚注册医疗器械的关键步骤。我们详细解析了自2012年起生效的《医疗器械法案737》(Medical Device Act 737)下的监管框架，包括医疗器械管理局(MDA)的角色、四级风险分类系统，以及不同类别器械的注册路径。我们还强调了指定马来西亚授权代表(AR)和遵循良好分销规范(GDPMD)的重要性。 • 马来西亚医疗器械监管的核心法规是什么？ • 为什么必须指定本地授权代表 (AR)？ • 您的设备属于哪个风险等级（A、B、C还是D）？ • A类和B/C/D类器械的注册流程有何不同？ • 什么是通用提交档案模板 (CSDT)？ • 合格评定机构 (CAB) 在审批中扮演什么角色？ • 医疗器械注册的有效期是多久？ • 什么是MeDC@St系统，它在注册中起什么作用？ 准备好将这些见解转化为您的竞争优势了吗？Pure Global 的法规专家为医疗科技公司在全球30多个市场的每一步提供指导。请访问我们的网站 https://pureglobal.com/ 或发送电子邮件至 info@pureglobal.com 了解我们如何加速您的市场准入，获得量身定制的支持。
2025-07-0502 minAcceso Global al Mercado de Dispositivos Médicos
Acceso Global al Mercado de Dispositivos MédicosSu Vía de Acceso al Mercado de Dispositivos Médicos de MalasiaEste episodio ofrece una guía detallada sobre el proceso de registro de dispositivos médicos en Malasia. Analizamos la legislación clave, la Ley 737, el papel indispensable del Representante Autorizado (AR), el sistema de clasificación de riesgos y el proceso de solicitud a través del portal MeDC@St, incluyendo la función de los Organismos de Evaluación de la Conformidad (CAB). • ¿Cuál es el primer paso obligatorio para un fabricante extranjero que desea ingresar al mercado de Malasia? • ¿Cómo determina la clasificación de riesgo de un dispositivo (Clase A, B, C o D) la vía regulator...
2025-07-0403 minGlobaler Marktzugang für Medizinprodukte
Globaler Marktzugang für MedizinprodukteIhr Wegweiser für den Marktzugang von Medizinprodukten in MalaysiaIn dieser Folge untersuchen wir den regulatorischen Weg für das Inverkehrbringen von Medizinprodukten in Malaysia. Wir befassen uns mit dem zentralen Gesetz, dem Medical Device Act 2012 (Gesetz 737), der Rolle der Medical Device Authority (MDA) und dem schrittweisen Verfahren, das Hersteller befolgen müssen, von der risikobasierten Klassifizierung über die Konformitätsbewertung durch eine CAB bis hin zur Unternehmenslizenzierung und finalen Produktregistrierung. • Was ist das zentrale Gesetz, das den malaysischen Medizintechnikmarkt regelt? • Welche Rolle spielt die Medical Device Authority (MDA)? • Wie wird mein Medizinprodukt in Malaysia klassifiziert? • Was ist ein Conformity Assessment Body (CAB) und warum ist er unerlässlich? • Welche Lizenz b...
2025-06-2803 min医療機器グローバル市場アクセス
医療機器グローバル市場アクセスマレーシア市場への鍵：医療機器登録のステップバイステップ解説このエピソードでは、マレーシアの医療機器規制の枠組みについて詳しく解説します。2012年医療機器法（Act 737）に基づき、医療機器庁（MDA）が管轄する登録プロセスをステップごとにご紹介。リスク分類、正規代理人（AR）の役割、適合性評価機関（CAB）の審査、そしてオンライン申請システムMeDC@Stを通じた手続きの流れを理解することで、スムーズな市場参入を目指します。 • マレーシアで医療機器を規制する主要な法律は何ですか？ • 自社の製品はどのリスククラス（A、B、C、D）に分類されますか？ • 海外製造業者が必ず指定しなければならない現地代理人（AR）の役割とは？ • 適合性評価機関（CAB）による審査が必要なのはどのクラスの機器ですか？ • 申請はどのオンラインシステムを通じて行われますか？ • 登録申請に必要な主要書類（CSDTなど）は何ですか？ • 承認までのおおよそのタイムラインは？ • 登録証の有効期間は何年ですか？ これらの知見を競争優位に変える準備はできましたか？Pure Globalの規制専門家が、世界30以上の市場でMedTech企業をあらゆる段階でサポートします。当社のウェブサイト https://pureglobal.com/ をご覧いただくか、info@pureglobal.com までEメールでご連絡いただき、貴社に合わせたサポートについてお問い合わせください。
2025-06-2802 minMedical Device Global Market Access
Medical Device Global Market AccessUnlocking Indonesia: Your MedTech Entry StrategyThis episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT, labeling in Bahasa Indonesia/English, the new Halal certification mandate from January 2023, import restrictions, taxes, post-market surveillance, and license validity. Practical advice is offered to help manufacturers navigate this complex landscape. Key Questions: • What is the role of Indonesia's NADFC/BPOM in medical device registration? • Why is a Local Authorized Representative esse...
2025-06-2203 minAcceso Global al Mercado de Dispositivos Médicos
Acceso Global al Mercado de Dispositivos MédicosClaves Regulatorias para Dispositivos Médicos en IndonesiaEste episodio detalla los requisitos cruciales para comercializar dispositivos médicos en Indonesia. Nosotros cubrimos desde la designación de un representante local y la clasificación de dispositivos, hasta la documentación necesaria como el CSDT (Common Submission Dossier Template), la certificación ISO 13485, y el nuevo requisito de certificación Halal vigente desde enero de 2023. También se abordan las obligaciones post-comercialización y consejos prácticos. Una guía esencial para fabricantes que buscan expandirse al mercado indonesio. • ¿Cuáles son las primeras acciones regulatorias al apuntar al mercado indonesio de dispositivos médicos? • ¿Por qué es crucial un Represen...
2025-06-1805 min医療機器グローバル市場アクセス
医療機器グローバル市場アクセスインドネシア医療機器市場：参入と規制のキーポイントインドネシアの医療機器市場への参入は、複雑な規制、管理、市場特有の要件への対応が必要です。このエピソードでは、インドネシア保健省への登録、現地代理人の役割、機器分類、ライセンス取得、必須文書、ISO 13485品質管理、表示言語要件、2023年1月から施行されたハラル認証(Halal Certification)、輸入制限と税金、市販後調査、ライセンス有効性と更新、そして実用的なヒントについて概説します。 主な質問： • インドネシアで医療機器を登録する際の規制当局はどこですか？ • 外国製造業者がインドネシアで医療機器を直接登録できますか？ • 医療機器の承認プロセスにおける現地代理人（LAR）の重要性とは？ • インドネシアでは医療機器はどのように分類されていますか？ • 登録に必要な主要な書類（例：CSDT、ISO 13485）は何ですか？ • 表示および取扱説明書の言語要件は何ですか？ • 2023年1月から医療機器にハラル認証が必須となった背景は何ですか？ • インドネシアへの医療機器輸入に関する制限や税金はありますか？ • 市販後調査にはどのような活動が含まれますか？ • 医療機器ライセンスの有効期間と更新プロセスは？ これらの洞察を競争優位性に変える準備はできていますか？Pure Globalの薬事専門家が、世界30以上の市場で医療技術企業をあらゆる段階でガイドします。弊社がどのように貴社の市場参入を加速できるか、詳細はhttps://pureglobal.com/をご覧いただくか、info@pureglobal.comまでお問い合わせください。
2025-06-1205 min의료기기 글로벌 시장 진입
의료기기 글로벌 시장 진입인도네시아 의료기기 시장 진출 전략: 규제부터 할랄 인증까지이 에피소드에서는 인도네시아 의료기기 시장 진출 시 반드시 알아야 할 핵심 규제, 행정 및 시장별 요구 사항을 심층적으로 다룹니다. 규제 당국, 현지 대리인 지정, 기기 등급 분류, 허가 절차, 필수 서류, ISO 13485, 라벨링 요건, 2023년부터 시행된 할랄 인증, 수입 제한 및 시판 후 조사까지 상세히 설명하여 성공적인 시장 안착을 지원합니다. 주요 질문: • 인도네시아 의료기기 등록을 담당하는 주요 규제 당국(NADFC/BPOM)은 어디인가요? • 외국 제조업체가 인도네시아에 의료기기를 직접 등록할 수 있나요, 아니면 현지 공인 대리인(LAR)이 필요한가요? • 인도네시아의 의료기기 등급 분류(A, B, C, D 등급)는 무엇이며, 이것이 등록 절차에 어떤 영향을 미치나요? • 의료기기 수입 및 유통을 위해 필요한 주요 허가(NIB, IDAK/MDDL)는 무엇인가요? • ASEAN 공통 제출 서류 양식(CSDT) 외에 필요한 핵심 서류(CFS, ISO 13485 인증 등)는 무엇인가요? • 제품 라벨링 및 사용 설명서에 대한 언어 요건(인도네시아어/영어)은 어떻게 되나요? • 2023년 1월부터 인도네시아 의료기기에 할랄 인증이 필수라는 사실(대통령령 제6/2023호)을 알고 계셨나요? • 인도네시아로 의료기기 수입 시 제한 사항(예: 중고기기 금지) 및 관련 세금은 무엇인가요? • 성공적인 시장 진입 후 필요한 시판 후 조사 활동은 어떤 것들이 있나요? • 의료기기 허가의 일반적인 유효 기간과 갱신 절차는 어떻게 되나요? 이러한 통찰력을 귀사의 경쟁 우위로 전환할 준비가 되셨습니까? 퓨어 글로벌(Pure Global)의 규제 전문가들은 전 세계 30개국 이상 시장에서 의료 기술 기업의 모든 단계를 안내합니다. https://pureglobal.com/ 웹사이트를 방문하시거나 info@pureglobal.com으로 이메일을 보내 귀사의 시장 진출을 어떻게 가속화할 수 있는지 알아보십시오.
2025-06-1205 minYou Oughta Know: The Motivation Series (Video Version)
You Oughta Know: The Motivation Series (Video Version)You Oughta Know Lennia Matos (Video)In this episode, Matt is joined by Lennia Matos. Lennia is a professor at Pontificia Universidad Católica del Perú. She is also an SDT international scholar and Editorial Member for the CSDT. Together, they explore the mechanics and techniques one can use to enhance teaching in educational settings. They discuss how satisfying the three basic needs enhances the motivational experience and how positive motivation supports learning overall. We discuss the relationship dynamics between teacher and student. Matt references Nathalie Aelterman from Impetus Academy. You can find more about Impetus here: https://www.im...
2024-06-1748 minYou Oughta Know: The Motivation Series
You Oughta Know: The Motivation SeriesYou Oughta Know Lennia MatosIn this episode, Matt is joined by Lennia Matos. Lennia is a professor at Pontificia Universidad Católica del Perú. She is also an SDT international scholar and Editorial Member for the CSDT. Together, they explore the mechanics and techniques one can use to enhance teaching in educational settings. They discuss how satisfying the three basic needs enhances the motivational experience and how positive motivation supports learning overall. We discuss the relationship dynamics between teacher and student. Matt references Nathalie Aelterman from Impetus Academy. You can find more about Impetus here: https://www.im...
2024-06-1748 minThe Cricket Scotland Podcast
The Cricket Scotland Podcast2024: Episode 2 - Steve Snell and Robbie NelliesIn this week's episode of the Cricket Scotland Podcast, we speak with Falkland CC's Robbie Nellies after he was awarded a BEM in the New Year's Honours for his services to cricket, and then catch-up with Cricket Scotland's new Head of Performance Steve Snell to discuss his plans for the role! You can get in touch with the podcast on social media using the #CSPodcast Find out more about the Cricket Development Trust on their website: https://www.csdt.org.uk/
2024-01-1251 minDemystifying NMO & MOG
Demystifying NMO & MOGEpisode 23 | Service Dogs 101In this episode, we are joined by professional service dog trainer Leslie Horton to talk about all things service dogs, including what they are, legal protections, and training. We try to clear up some common misconceptions and touch on how they differ from emotional support animals, behavior standards in public, and being a “Certified” service dog.She owns Most Fine Canine in Frederick, Maryland, where she has spent over 20 years training and specializing in service dogs. She is certified as a dog trainer and service dog trainer and was inducted into the International Association of Canine Professionals (IACP...
2023-03-1437 minRugby Coach Weekly
Rugby Coach WeeklyRoundup Rodeo Ep83: Reviewing the best contentSend us a textHost Phil Llewellyn with guests review some of the many great podcasts, books, articles and webinars from the last week. This week's guests: Jonny McMurty coach, coach educator and researcher with Rugby Australia and Queensland University and Peter Hughes, athletic development coach with Ulster Rugby. This Week's ContentJonny McMurty Current Research                                 Coaching The Coaches – Jonny McMurtySUGGESTED CONTENT/WHAT YOU MIGHT HAVE MISSED Self Determination Theory and Motivation – Kendra Cherry Centre for Self Determination Theory – CSDTPositive Psychology Theory In A Nutshell – Catarina Lino6 Psychology The...
2022-04-101h 26WeX TALKs Podcast | belfa
WeX TALKs Podcast | belfa#004 NL | Het hybride werken, hefboom naar duurzaam werken? Sparkling thoughts met Isabel De ClercqHet Hybride Werken, de hefboom naar duurzaam samenwerken ?Samen op weg naar duurzaam werk: een opdracht voor het individu, organisatie én de samenleving.Sangara Klespis (WeX leader) en Joke Janssens (HR Hub), WeX verkenners, hebben bijzonder genoten van het boek van Isabel : "Het Hybride Werken: Een manifest". De inhoud is perfect in lijn met de lopende reflecties binnen WeX stream binnen de belfa community.We vonden het dan ook een must Isabel voor de micro te halen. Het interview was een stimulerend en inspirerend moment. Luister naar de podcast om je te la...
2022-01-2033 minK9s Talking Scents
K9s Talking ScentsSeason 3 Episode 51 Genetics, Puppies and Training with Mike SuttleThis Episode we speak with Mike Suttle of Logan Haus Kennels... Mike is a well know breeder and trainer. Mike has well proven breedings of Malinois and Dutch Shepherds as well as Labradors. I personally have had 2 dogs from Logan Haus (1 Malinois and 1 Labrador) both have been outstanding dogs. *Episode Warning, Mike is on a cell phone during this interview and at times has spotty signal, he cuts out from time to time but you can still follow what he is saying and speaking about. Logan Haus Kennels is owned by Mike Suttle. Mike has been training and raising...
2021-09-231h 31The Calvin Nellum Podcast
The Calvin Nellum PodcastCsdt.org (Culturally Situated Design Tools) ( feat: Madison Allen and Andrew Hunn)WE BACK!! Csdt.org aka Culturally Situated Design Tools is a website that combines culture and math and helps bring IDENTITY to Math, Science, and STEM classes. Scholars will be able to do math and science while also seeing themselves in the work they create. When you go to the website, you will find a text that reads..." The elitist myths of "savages" and "white trash" led to today's bigotry. Here you can counter those stereotypes with African fractals, Appalachian quilting algorithms, and more. From Native beadwork to urban graffiti, students can find th...
2021-09-0952 minK9s Talking Scents
K9s Talking ScentsSeason 3 Episode 50: Mike Ritland “Put yourself in their shoes”This is episode 50!!! Landmark episode for K9s Talking Scents.  I get to sit down with former Navy SEAL Mike Ritland, author of Trident K9 Warriors, Navy SEAL dogs, and Team Dog. Host of podcast Mike Drop, Owner of Trikos K9, Team Dog, as well as Founder of Warrior Dog Foundation and there are always a few more things Mike does to keeps himself busy.  You can check out more about Mike Ritland and all he has to offer at www.mikeritlandco.com   Mike and I cover a lot of information in this epi...
2021-09-031h 48K9s Talking Scents
K9s Talking ScentsSeason 3 Episode 49 K9 Mussels with Debi DeShonDebi DeShon is passionate about animals and our environment. Ms. DeShon received a Bachelor’s degree in Agricultural Business and Management from UC Davis in 1987. Afterwards, she attended Moorpark College and earned an Associates degree in Exotic Animal Training and Management in 1989. Mrs. DeShon then launched her career in Hollywood training dogs for television and such iconic movies as "Beethoven". Subsequently she began working with Interquest Detection Canines as a canine handler in 1996. She has operated four Interquest Detection Canines franchises since 1999, and has been successfully training and managing canine teams in the detection of illegal drugs and contraband. Mr...
2021-08-121h 26The Calvin Nellum Podcast
The Calvin Nellum PodcastThe Father of African Fractal Dr. Ron Eglash: Afro-Futurist GreenhouseWELCOME BACK!I should I say welcome HOME! I met Dr.Ron Eglash last summer after my first conversation with the brotherman. I felt at home! Dr.Ron Eglash is the Father and author of African Fractals. He has a world-famous TED Talk, "The fractals at the heart of African Design,"  which is pure stunning due to its fusion of African cultures and science, technology, engineering, and math. He starred in Samuel L. Jackson's mini-doc series  Enslaved.Ron is currently working on building an African inspire greenhouse in the city of Detroit! Ron and...
2021-08-0539 minK9s Talking Scents
K9s Talking ScentsSeason 3 Episode 47 "The Details of Detection" with Dr. Astrid ConchaDr. Concha is a Postdoctoral research associate at the US Army Research Office. Dr. Concha has 20 years of experience that encompasses working in clinical animal behaviour, working as a detection dog trainer, and working as a researcher. She earned her PhD in animal behavior from the University of Lincoln (UK), has worked with Medical Detection Dogs (UK), and has worked with Police and Military Working Dogs across the world. Her primary research area is the study of canine olfactory performance and developing novel technologies to measure alert responses in detection dogs. Dr. Concha is currently working with Military Working...
2021-07-011h 49K9s Talking Scents
K9s Talking ScentsSeason 3 Episode #46 The Journey of Detection with Paul BunkerIn this episode we speak with world-renowned detection dog trainer and author Paul Bunker of Chiron K9. Author of the new book "Imprint your Detection Dog in 15 days" which you can purchase here: https://www.amazon.com/dp/0578896516 Paul Bunker served in the British Army as a Canine Trainer/Instructor/Assessor for over 22 years. During this time, he was the Senior Instructor/Trainer of Explosive Detection Dog/Handler Training for both UK and US Military at the UK Defence Animal Centre. He developed new training techniques and methodologies that are now considered internationally standard training practice.
2021-05-271h 36K9s Talking Scents
K9s Talking Scents3 Episode 45: "Legally speaking" with Mike KmiecikOn this Episode we speak with Mike Kmiecik of the Sheepdog Guardian / K9 Legal Update website. Mike is a 24-year law enforcement veteran and 15-year veteran police service and working dog handler.  Mike has handled multiple dogs specialized in patrol, narcotic-contraband detection and human remains detection (including as a mobile field force canine operator).  Mike has more than 8,000-hours of training in law enforcement and police service dog operations.  Mike has been the recipient of numerous awards from the Bartlett (Illinois) Police Department (including Life Saving, Meritorious Service, Honorable Unit/Shift Citations and Officer of the...
2021-04-291h 58K9s Talking Scents
K9s Talking ScentsS3 Episode 44: "On the record" with Dr. Mary CablkDr. Cablk is well known in the SAR community and more recently become known to Law Enforcement on various cases she has testified on. We discuss all this is so much more. Dr. Mary E. Cablk is an expert in detection and systems. In her research, she draws upon knowledge from multiple fields such as olfaction, analytical chemistry, learning, cognitive and industrial/occupational psychology, forensics, spatial analysis, pattern analysis, and image processing. Her interests focus on transforming qualitative observation into quantitative data and combining multiple input data types to solve complex challenges related to detection, in a field setting...
2021-04-082h 16K9s Talking Scents
K9s Talking ScentsSeason 3 Episode 43: The mind of a puppy with Dr. Emily BrayOn this podcast, we get to finally discuss the cognition testing and research on how predictable the cognition tests on puppies are in determining if they are potential detection or working dogs.  Many of us who work breed or train dogs always know its a crap shoot at times to know if the puppy we are working with can or will turn out to do what we hope.   Dr. Emily Bray conducted her post-doctoral research associate at the Arizona Canine Cognition Center (in the School of Anthropology at the University of Arizona) and Canine Companions fo...
2021-03-121h 54psyjk - Psychologie für alle
psyjk - Psychologie für allePsychische GrundbedürfnisseUnser Körper braucht Nahrung, Wasser, Erholung - das kennen wir. Aber unsere Psyche hat auch Bedürfnisse. Wenn diese nicht erfüllt werden, geht es uns nicht gut. Interessanterweise reichen bereits drei Begriffe, um die Grundbedürfnisse zu beschreiben (so lautet zumindest eine der bekanntesten Theorien aus diesem Bereich). Welche das sind, erfahrt ihr natürlich in dieser Folge. Wir erzählen außerdem, inwiefern uns beiden dieses Konzept der Grundbedürfnisse auch persönlich hilft, um Entscheidungen zu treffen oder über Erfahrungen nachezudenken. Jelenas Quellen: 1) „Selbstbestimmung/Selbstbestimmungstheorie“ in Dorsch Lexikon der Psychologie, Hogrefe Verlag. https://dorsch.hogrefe.com/st...
2021-03-0552 minK9s Talking Scents
K9s Talking ScentsSeason 3 Episode 42: The Military process to Nosework with Bill GaskinsOn this Episode I get to speak with Bill Gaskins of Integrity Noseworx. Bill is the son of two retired police officers in Oregon and has been working with dogs since he was 11 years old. During his Air Force Experience Bill a Military Working Dog Handler of 10 different dogs, Dog Trainer for over 50 operational Dog Teams and Kennel Master managing kennel operations all over the world. As a canine training instructor, Bill trained and certified over 624 dog teams in tasks from Obedience, Patrol Protection as well as Explosive and Narcotics detection. Bills experience culminated as the course...
2021-02-171h 12K9s Talking Scents
K9s Talking ScentsSeason 3 Episode 41: Ken Pavlick and the P's of Detection dogsOn this episode we speak with Ken Pavlick of Pacific Coast K9. Ken has been working dogs for over 30 years.  He was first in the USAF as a MWD Handler, then a Police Officer and K9 Handler for agencies on the West Coast.  Later he opened Pacific Coast K9 located in Washington and has been training and selling detection dogs ever since.  Ken due to his experience is a wealth of knowledge and has a lot of great info to share with our listeners.     You can contact Ken at www.pacificcoastk9.com    Show...
2021-02-031h 23K9s Talking Scents
K9s Talking ScentsSeason 3 Episode 40: "We all have the same problems" with Don BlairDon Blair had his start with working K9s as a police officer. Having served as a K9 officer for 5 years, he moved into US Customs and Border Protection and quickly worked his way through a variety of roles including Canine Enforcement Officer, Instructor/Course Developer and Canine Branch Chief. He was responsible for supervision of Department of Homeland Security/Customs Border Protection anti-terrorism inspections and special enforcement operations as well as canine training and research development programs.   After founding CIA in 1984, Don continued to procure skills in optimizing canine learning through the attendance of n...
2021-01-161h 41K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 39: "Explosive Science" with Todd WilberThe last Episode of Season 2 goes out with a bang!!! In this episode, I speak with Todd Wilber.   Todd Wilber, President of Precision Explosives LLC Todd has worked for over 20 years in counterterrorism as a responder, researcher, policy writer and senior manager. He responded to various incidents at the local, national and transnational levels. His experience includes battlefield firsthand experience with improvised explosives and IEDs. He conducted research on various improved explosives and developed novel render safe procedures for IEDs as well as nuclear devices. Mr. Wilber is completing work on new, broad use desensitization s...
2020-12-301h 21K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 38: "Talking training and Bio Detection" with Wesley VisscherIn this podcast, I sit down with my good friend Wesely Visscher owner of Scent Imprint for Dogs (based in Holland).  Wesely has been working and training detection dogs for many years now and more recently has been very focused on the Bio Detection and Conservation Detection worlds.  Conservation and Bio Detection dogs are an emerging market and we discuss this as well as many other detection training topics.   You can contact Wesley at info@scentimprint.com or go visit his website at www.scentimprint.com Show Sponsors: FORD K9 LLC.   www.fordk9.com
2020-12-181h 12K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 37: "The value of failure" with NYPD Lt. John Pappas and Sgt. Randy BrennerThis is a powerful episode where we talk to the Commanding officer and unit Sgt. of the prestigious NYPD Transit Bureau K9 unit. This unit is comprised of over 50 dog teams and protect NY City for every major event that happens, from UN National Assembly, US OPEN, New Year's Eve, Times Square, the entire subway system in their jurisdiction, and so much more.  We cover the "value of failure" and pushing yourself outside your comfort levels so you and your dog can grow as a team.  Hope you enjoy it.   Lt. John Pappas: over 25 years of...
2020-11-201h 27K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 36: "Under the Surface" with Paul MartinPaul S. Martin, M.A. is an anthropologist and K9 handler for History Flight, Inc. with K9 Ziva, where they assist in the search and recovery of missing American Service Members from foreign conflicts. He also provides archaeological consulting services through Martin Consulting. He is an affiliate of the Society of American Archaeology, the Society of Exploration Geophysicists, and is the past president of the National Network of Canine Detection Services. He is a member of the AAFS Standards Board Consensus Body for Dogs and Sensors. He is the cofounder of HRD Specialized K9 Training that was esta...
2020-10-261h 13K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 35: Importance of Standards with Robin GreubelRobin has been involved in detection work since 2001, beginning in wilderness and human remains detection (HRD), which expanded into disaster work. She trains and deploys with Nebraska Task Force 1 and Iowa Task Force 1. She is a certified explosives and narcotics detection dog handler.  Subject matter expert for the AAFS Dogs and Sensors Consensus Body Federal Emergency Management Agency (FEMA), where she is an instructor and evaluator for both live and HRD Alliance for Emergency Response Instructors and Examiners (AERIE), where she is a certified search manager, a search management instructor and Director of th...
2020-09-281h 27K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 34: (Detection Eh') with Gord McGuinessGord McGuinness is currently a member of the Metro Vancouver Transit Police Service in British Columbia, Canada. This new assignment follows a 34-year career with the Vancouver Police Department. Prior to his retirement from the VPD, Gord spent 18 of 34 years as a canine handler and worked five police service dogs during his time in the VPD Canine Unit. For more than a decade Gord held the position of Head Trainer in the Canine Unit where he was responsible for implementing the first single purpose, narcotic and explosive detection dog teams in the history of the Vancouver Police...
2020-09-101h 09K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 33: Cop surrounded by Science (Robert "Doc" Dougherty)Cheltenham Township Police Officer Robert "Doc" Dougherty has become an integral member of the Penn Vet Working Dog Center as law enforcement canine coordinator. With more than 31 years of law enforcement and K9 experience, "Doc" brings vital training skills to the program.   Penn Vet website https://www.vet.upenn.edu/research/centers-laboratories/center/penn-vet-working-dog-center   Show Sponsors: FORD K9 LLC.   www.fordk9.com Attend any one of our classes or seminars.  Ford K9 now offers the new CSDT (Certified Sport Detection Dog Trainer) classes.  We offer Level 1 and Level 2...
2020-08-261h 35K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 32: Experience Speaks volumes with Sonja NordstromSonja's accomplishments with dogs and training credentials achieved during the last 25 years are unmatched. In 2014, Sonja retired from the FBI after 23 years of service as a Special Agent and opened Sonja's Dog Training.  While serving with the FBI, Sonja completed thousands of hours of training under nationally recognized trainers, competed in the protection sports of Schutzhund, Mondioring, and French Ring, attained local and national level search dog certifications, completed 100's of field missions with her K9s for the FBI and others, and has trained and worked with 100's of dogs of all ages and types.  For approxim...
2020-08-111h 42K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 31: Dr. Cindy Otto of Penn VetIn this episode, I interview the fascinating Dr. Cindy Otto is an associate professor and veterinarian with specialty certification in both Veterinary Emergency and Critical Care and Veterinary Sports Medicine and Rehabilitation. She has worked in the Emergency Service at the University of Pennsylvania MJ Ryan Veterinary Hospital for over 20 years. She has been a member of FEMA’s Pennsylvania Urban Search and Rescue Task Force 1 from 1994-2010. She is a certified trick dog instructor (CTDI) and has been training dogs for the past 10 years. Most recently she has founded the Penn Vet Working Dog Center and serves as th...
2020-07-201h 15K9s Talking Scents
K9s Talking ScentsSeason 2 Episode 30: The Great Podcast MashupScent detection is an art form in dog training that is best described as a methodology with many nuances. Two very well respected trainers who are well known for their work in scent training join us for this episode. Jerry Bradshaw and Cameron Ford join us again, this time together, to share their ideas and techniques in scent training. Like most trainers, both of these gentlemen have their respective style. Although we may have our preferences, we can’t deny good training and results. Making sense of scents is a skill set that al...
2020-06-221h 45