Webinar: Update on Medical Device Regulations in Philippines |
In a recent webinar, Priya Bhutani introduced significant regulatory changes in the ASEAN market, particularly focusing on the Philippines. She emphasized the importance of new guidance from the FDA for medical device manufacturers, which began implementation in March 2020. The webinar featured Mary Joy Manzo, a regulatory expert with over 20 years of experience, who detailed the new classification system for medical devices, which now includes classes A through D based on risk levels.
Key points covered include:
All class A devices must apply for a Certificate of Medical Device Notification (CMDN).
Existing certificates for exempt devices will remain valid until November 2021, after which manufacturers must apply for CMDN.
The transition to a new documentary format aligns with the ASEAN Medical Device Directive (AMDD).
Key regulatory changes include the elimination of the Certificate of Free Sale requirement and the shift from manual to online submissions for CMDN applications.
The timeline for application processing has been expedited, with initial assessments conducted within five days.
The session concluded with a Q&A, encouraging attendees to engage and clarify their queries about compliance with the new regulations.