Medical device distribution in the Philippines
Only registered medical devices may be imported into the Philippines, that means they must be registered with the Food and Drug Administration’s (FDA) Center for Device Regulation, Radiation, Health and Research (CDRRHR) and been issued with a Certificate of Medical Device Notification (CMDN), a Certificate of Medical Device Registration (CMDR) or a Certificate of Product Registration (CPR) unless exempted from registration (see below).
Who can distribute medical devices in the Philippines?
What are the requirements for distributing medical devices in the Philippines?
Advertising, communication and promotion of medical device is part and parcel of distribution. In Philippines, promotion and marketing of medical devices should comply with AO 2015-0053: Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices. For sales promotions involving prizes, a permit must be obtained from the FDA. The fees due depend on the value of the prizes available.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in the Philippines to:
How Andaman Medical can help with distributing medical devices in the Philippines:
Andaman Medical holds a valid License To Operate as an Importer of medical devices, in-vitro diagnostics in the Philippines. We remain independent from any final distribution channel partner you choose to appoint ensuring you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to: