The Philippines, with a population of about 117 million, is the second most populous country in Southeast Asia and presents a significant opportunity for medical device manufacturers, given its growing healthcare sector and reliance on imported medical devices. The country's integration into the ASEAN Medical Device Directive underscores its commitment to harmonizing regulatory standards and facilitating Philippines medical device registration for high-quality medical devices.
COFEPRIS introduced sweeping reforms in June 2025 that streamline medical device registration for foreign manufacturers, including recognition of international approvals, expanded GMP documentation options, new homologation codes, and a 30-day review timeline. These changes mark a major step toward regulatory alignment with global standards and faster market access in Mexico.
This webinar was hosted by Dr. Oliver Eikenberg and featured our Guest Speaker, Ms. Eva Camatini, Notified Body - IMQ.
Explore articles and insights our team has published in leading media and industry platforms.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
