Philippines FDA Licensing of Medical Device Retailers
The Philippines FDA (Food and Drug Administration) has published a draft version of “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”. This draft is now open for comments from concerned parties until 24 July 2021.
The draft guidelines specify those establishments that are required to obtain licenses to retail medical devices. The document lists specific requirements for establishments such as responsibilities of qualified persons, advertising and post-licensing inspections of medical device retailers.
Who is considered a “retailer of medical devices”?
The guidelines apply to establishments/institutions that offer/sell medical devices such as:
- Retail stores
- Clinics except those that are covered by the Department Of Health One Stop Shop Licensing System
- Sellers of online shopping website, social media platforms and/or TV shopping companies
- Operator of medical device vending machine
- Optical shops
- Drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription drugs (RONPD)
This circular shall not cover grocery stores, supermarkets, convenience stores, chandler, kiosks and other similar stores (AO 2020-0017). But the afore-mentioned establishments shall be held liable and shall be considered violating the Philippines’ FDA regulations if they sell or offer to sell unregistered or unnotified medical devices.
However, please note that any distributor, importer, exporter or wholesaler that sells medical devices to the general public is considered a medical device retailer.
Key clauses for your attention: Spot inspections and online selling of prescription medical devices
- The draft guidelines state that all licensed retailers shall be subject to routine or spot check inspection during operating hours by authorized FDA personnel.
- The online selling of prescription medical devices is prohibited. Advertising is allowed for such product, however advertisements with a link for online purchase of prescription medical devices is not.
- The proposed guidelines once finalized and implemented shall take effect fifteen (15) days after publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the University of the Philippines – Office of the National Administrative Register.
To submit your comments on the draft guidelines:
Please send your comments to the following email address [email protected] with a CC to [email protected] . The deadline to submit comments is 24 July 2021.
Andaman Medical clients may submit their comments to the Regulatory Affairs Specialist in charge of their dossier marked for the attention of the Philippines Office with the subject “PFDA Comments on Retailer Licenses”.
To learn more about registering medical devices in the Philippines click here.
We can register and import your medical device into the Philippines. Contact our sales team to find out more by clicking on the button below.