The Filipino FDA is now circulating a document that will allow abridged processing of medical device applications in the Philippines if the device has already been approved in another ASEAN country. Abridge processing refers to a quicker evaluation with respect to AMDD-CSDT requirements. Of course, a shorter approval route in the Philippines requires that the exact same device has been approved in another ASEAN country, and the exact same technical requirements were submitted. Shorter processing will only apply to devices classified as B, C, and D. If there are any problems with the device in other ASEAN countries, or other issues arise, the Filipino government will have the right to waive abridged processing.
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.