Recently, the Philippines FDA issued a new circular that will guide companies that import, distribute, manufacture, or sell medical devices. Issues are outlined on topics including shipping out products first that are close to the expiration date, first items into storage are the first items to be shipped out, the marketing authorization holder is responsible for adhering to this circular, etc. More detailed records will be needed for the device manufacturers who ship products, distributors who sell products, and other retail companies who are involved in these services. These groups will need to keep better records of their personal, SOPs, premises, storage of stock, etc. Also, there will be more emphasis on complaints, recalls, disposing devices, and counterfeit products.
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.