This episode provides a detailed overview of the mandatory requirement for medical device manufacturers to appoint a Saudi Authorized Representative (AR) to enter the market in Saudi Arabia. We explore the key responsibilities of the AR, from regulatory submissions with the Saudi Food and Drug Authority (SFDA) to post-market surveillance, and analyze the strategic advantages of appointing an independent AR over a commercial distributor.
Key Questions
• What is a Saudi Authorized Representative and why is it mandatory for foreign manufacturers?
• What are the essential duties an AR performs on behalf of a medical device company?
• What are the benefits of choosing an independent AR versus appointing your distributor?
• How did the regulations for low-risk medical devices change on September 27, 2022?
• What qualifications must a local entity possess to become an SFDA-approved AR?
• What is the process for submitting a Medical Device Marketing Authorization (MDMA) via an AR?
• Can a manufacturer change their appointed AR without re-registering their products?
• What legal documentation is required to formalize the relationship with a Saudi AR?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
