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Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices

On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and Procedures” was issued wherein retailers of medical devices are included in the list of establishments that are required to secure a License to Operate from the FDA before engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship activities of health products.

This guide aims to:

A. Specify the establishments classified as retailers of medical devices;

B. Clarify the licensing of drug outlets which are also retailers of medical devices;

C. Provide specific requirements for and responsibilities of qualified persons of retailers of medical devices; and

D. Provide specific requirements for post-licensing inspection of retailers of medical devices.


This guide shall apply to the following retailers of medical devices:

A. Retail stores for medical devices;

B. Clinics that sell products classified as medical devices except those that are covered by the DOH One Stop Shop Licensing System;

C. Sellers using online shopping website, social media platforms and/or TV shopping companies in selling or offering to sell medical device directly to the general public;

D. Operator of medical device vending machine;

E. Optical shops; and

F. Drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription drugs (RONPD) that also sell or offer to sell medical device


Check out this circular for more details on this LINK Licensing of Retailers of Medical Devices in the Philippines

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