Medical device importation to 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). All medical devices and in-vitro diagnostics that are in circulation in the Philippines as well as those that are exported are listed in the FDA Verification Portal System.
What are the requirements for importing medical devices into the Philippines?
Are there any exemptions or exclusions?
Special Access Routes for importing medical devices into the Philippines
Special cases where special permits/certifications/exemption are issued for unregistered medical devices:
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to the Philippines to:
How Andaman Medical can help with importing medical devices to the Philippines:
Andaman Medical holds a valid License To Operate as an Importer of medical devices and 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: