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Philippines consults on plans to adopt ASEAN medtech registration requirements

This article was originally published in SRA

Executive Summary

The Philippines Food and Drug Administration is inviting feedback from stakeholders on its proposal to adopt new documentary requirements for the registration of medical devices based on the ASEAN Medical Device Directive1. The proposed requirements will not apply to in vitro diagnostics and refurbished medical devices as the FDA intends to issue separate requirements for these products at a later date.

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