Moves By Philippines To Tighten Regulation Spurs Concern By Medical Device Firms

With regulatory authorities in the Philippines moving to tighten registration requirements for medical devices, manufacturers are voicing concern that government authorities are not building in enough transition time for industry to reasonably comply.

Since January, Filipino authorities have begun phasing in new technical requirements and procedures for Class B, C, and D medical devices that are harmonized with the requirements of other ASEAN nations. Under the new regulations, products that have not either been issued a product license or have a license pending approval from the Philippines Food and Drug Administration (FDA) cannot be imported or distributed in the country after April 1, 2022.

Industry leaders are in consultations with the Filipino FDA on expanding the transition period. They are also asking the Filipino FDA to reconsider its decision to create a list of medical devices that authorities deem essential, along with a price reference list, that would be distributed to hospitals and other medical providers. Some manufacturers fear such a list could make it harder to compete with more well-known brands.

The changes have been years in the making since the Philippines and the other nine members of the Association of Southeast Asian Nations (ASEAN) signed an agreement in 2014 to harmonize such mandates. The ASEAN Medical Device Directive (AMDD) was established to ease logistics for importers and manufacturers and to improve safety and confidence among patients.

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.

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