Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements

The Food and Drug Administration of the Philippines (FDA) published Circular No. 2021-002, providing guidelines for the full implementation of the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements and outlining procedures for what have previously been non-registrable Class B, C, and D medical devices.

Background on ASEAN harmonization of medical device regulations

Creating a harmonized medical device regulatory framework has been a priority of ASEAN since the early part of last decade, and 2014 yielded the official signing of the ASEAN Medical Device Directive (AMDD) by all 10 member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. The transition to the harmonized framework has developed at varying rates, with Singapore and Malaysia achieving rapid progress while other ASEAN member states lagged behind.

In the Philippines, Administrative Order No. 2018-0002 was published in January 2018 and called for a new risk-based system of medical device classification, in line with ASEAN requirements. Initial implementation of the new framework was established by Circular No. 2020-001, which officially grouped devices into the four risk classes used by the AMDD. Annex A of this circular provided a list of registrable devices and designated the class that each fell into. For all Class A devices, regardless of whether they were included on the list, it was required to apply for a Certificate of Medical Device Notification (CMDN). Class B through D devices listed in Annex A required a Certificate of Medical Device Registration (CMDR), while those not on the list were exempt from registration requirements and could be imported by an importer with a valid License to Operate (LTO). This regulation went into effect on February 7, 2020.

New circular establishes registration of previously exempt medical devices

This year, the FDA of the Philippines published Circular No. 2021-002, which provides guidelines for the full implementation of ASEAN harmonized technical requirements and outlines the transitional procedures for what were non-registrable Class B, C, and D medical devices. It will now be required for these to apply for a CMDN, as is already the case for Class A devices. While this information is not fully provided in the circular, the FDA has confirmed in a communication to Emergo by UL that there will be a transition period of one year (i.e., to March 2022) provided in which to obtain the CMDN. Once issued, the certificate will be valid for two years and will not be renewable. The application procedure can be carried out through the FDA’s electronic portal and is identical to that currently in place for Class A devices.

In order to maintain market access for Class B through D devices, manufacturers and importers must subsequently apply for a CMDR. The CMDR application must be submitted at least three months prior to the expiration of the CMDN.

Additional circular adjusts classification status of several registrable devices and adds more to list

The FDA of the Philippines also published Circular No. 2020-001-A, which clarifies and/or amends the classifications listed in Annex A of last year’s circular. The changes are provided side-by-side with the pertinent classifications as they were previously given. Most notably, ventilators and resuscitators have been added to the list. No transition period is mentioned for registering ventilators or resuscitators, and no guidance is provided in the circular on how to deal with situations in which a device classification has changed. Emergo by UL has directed inquiries to the FDA regarding such cases. The circular also provides a listing of the Annex A device classifications that have not changed.

Further resources for medical device and IVD registration in Southeast Asia from Emergo by UL:

• Customized regulatory pathways for smaller markets