Medical devices already approved for sale in Association of Southeast Asian Nations (ASEAN) countries may be eligible for fast-track access to the Philippines market, according to a directive issued in November by the Philippines Food and Drug Administration.
Since February, Philippines regulatory authorities have moved to align their technical and application requirements with those established by the ASEAN Medical Device Directive, signed by all 10 member states four years ago.
The abridged application process went into effect in November. It still requires applicants to submit a raft of documentation in accordance with ASEAN harmonized technical requirements.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.fda.gov.ph/wp-content/uploads/2022/03/Abridged-processing-of-MDs-approved-by-other-ASEAN-Countries-2022-03-25.pdf