Philippine Medical Device Registration: Why Your MAH Choice is Critical

This episode delves into the essential role of the Marketing Authorization Holder (MAH) for medical device registration in the Philippines. We explore the regulatory requirements set by the Philippine FDA, the responsibilities of an MAH, and the critical strategic considerations for foreign manufacturers when selecting a local representative. Understanding the distinction between a distributor-as-MAH and an independent MAH is key to maintaining control over your market access and long-term business flexibility. Key Questions: • What is a Marketing Authorization Holder (MAH) and why is it mandatory in the Philippines? • Who is eligible to act as an MAH for medical devices? • What are the legal responsibilities of the MAH after a product is on the market? • Is it a good idea to appoint your distributor as your MAH? • How can your choice of MAH impact your business control and market flexibility? • What is a Certificate of Product Registration (CPR) and why is its ownership so important? • What happens to your device registration if you decide to switch distributors? • How does an independent MAH provide a more secure path to market? 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 [email protected] for tailored support.