Under draft rules released in January by the Philippines Food and Drug Administration (FDA), all in-vitro medical devices (IVDs) imported, marketed, or manufactured in the archipelago nation will soon for the first time be required to be registered with health authorities in the country. Previously, registration was required for only a few categories of IVD devices.
According to the draft, the new rules will be implemented in phases. Once implemented, they will bring the marketing of IVDs in the Philippines in line with the ASEAN Medical Device Directive (AMDD), the 2014 agreement of ASEAN member states harmonizing the regulation of medical devices. People or establishments seeking to sell IVDs classified under AMDD guidelines as moderate to high risk (Classes B, C, or D) must have a license to operate issued by the Philippines FDA, and then must be fully certified by the agency as complying with all requirements for registration.
Licenses and registrations granted for the sale of the IVDs will expire in two to five years under the draft regulations, and will be subject to renewal. IVDs strictly used for research, clinical trials or exhibits do not require notification and registration, but instead must be authorized by the Philippines FDA as intended for such study and not for sale.