Medical Devices Registration and Licensing Policy

The Order is issued under the Department of Health’s mandate to ensure an effective health and drug regulatory system through the regulation of medical devices.
The Order expressly anchors its rationale on the 1987 Constitution, including Section 11, Article II and Section 12, Article XIII.
The Order expressly aligns regulation with Republic Act No. 3720, as amended by Executive Order No. 175, also known as the “Food, Drugs and Devices and Cosmetic Act.”
The Order expressly recognizes Executive Order No. 102 (1999) as the basis for restructuring that created the Bureau of Health Devices and Technology (BHDT).
The Order expressly covers medical devices in relation to the Consumer Act of the Philippines under Republic Act No. 7394.

The Order declares a policy to harmonize Republic Act No. 3720 (as amended) and Executive Order No. 102, s. 1999 through unified registration and licensing policies.
The Order states that BFAD and BHDT must ensure the safety, efficacy, and good quality of medical devices applied for registration.
The Order reiterates the Department’s operational mandate to streamline and rationalize registration and licensing processes affecting medical device regulation.

The Order covers registration of medical devices and licensing of establishments dealing with medical devices.
The Order defines covered medical devices by reference to Republic Act No. 3720 (as amended), Executive Order No. 102, s. 1999, and related device concepts.
The Order covers establishments dealing with medical devices falling within the device framework under Republic Act No. 7394.

The BHDT acts as the technical arm of the BFAD on matters relative to medical device registration and establishment licensing.
Applications for registration of medical devices and licensing of establishments are processed, reviewed, and evaluated by BHDT whether filed directly or referred by BFAD, using prescribed or established Department and/or BFAD guidelines under Section IV.
The BHDT Director submits findings and recommendations to the BFAD Director, and the BFAD Director acts on the recommendations under Section IV.
The BHDT Director is the recommendatory officer and is held accountable for certificates and licenses approved by the BFAD Director that are based on the BHDT Director’s recommendations under Section IV.
BFAD and BHDT must furnish each other with all necessary information and data needed or required by the other, guided by mutual cooperation under Section IV.

No Certificate of Device Registration shall be issued without the approval and signature of the BFAD Director, with a copy furnished to the BHDT under Section IV.
No License to Manufacture, Refurbish, Import, Export, Sell, Distribute, Market and/or Store Medical Devices shall be issued without the approval and signature of the BFAD Director, with a copy furnished to the BHDT under Section IV.

BFAD and BHDT are authorized to charge the appropriate fees for their respective duties and responsibilities under the Order under Section V.
BFAD and BHDT must jointly formulate and agree on the procedure and manner by each Bureau conducts post-market monitoring and surveillance of medical devices under Section V.

The Order may be amended or revised from time to time for effective and efficient implementation of the laws and rules governing medical device registration and licensing, unless changed, modified, or rescinded by the Secretary of Health under Section IV.
Separability clause: If any part, term, or provision is declared invalid or unenforceable, the remainder remains valid and enforceable, and the invalid part is treated as if not contained in the Order under Section VI.
Repealing clause: All other Department issuances, bureau circulars, and memoranda inconsistent with the Order are withdrawn, repealed, and/or revoked under Section VII.