QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2007-0003)
It cites: (1) Section 11, Article II of the 1987 Constitution on making essential goods and health/social services available at affordable cost, and (2) Section 12, Article XIII on establishing and maintaining an effective food and drug regulatory system and undertaking appropriate health manpower development and research responsive to health needs and problems.
The Order harmonizes R.A. No. 3720 (as amended by E.O. No. 175), and E.O. No. 102, s. 1999.
BHDT is designated as the technical arm of BFAD on matters relative to registration and licensing of establishments dealing with medical devices; it processes, reviews, and evaluates applications in accordance with DOH/BFAD guidelines.
Its purpose is to harmonize R.A. No. 3720 (as amended) and E.O. No. 102, s. 1999 by setting policies and guidelines governing registration and licensing of medical device establishments, while consistently ensuring the safety, efficacy, and good quality of medical devices applied for registration.
It covers the registration and licensing of establishments dealing with medical devices defined under R.A. No. 3720 (as amended), E.O. 102, s. 1999, and R.A. No. 7394 (Consumer Act of the Philippines).
All applications for registration of medical devices and licensing of establishments are processed, reviewed, and evaluated by BHDT when filed directly or referred by BFAD, in accordance with prescribed/established DOH and/or BFAD guidelines.
BHDT, through its Director, submits findings and recommendations to the BFAD Director, who in turn acts on the same.
The BHDT Director (as recommendatory officer) is held accountable for certificates or licenses approved by the BFAD Director that are based on BHDT’s recommendation.
Both bureaus must furnish each other with all necessary information and data that may be needed or required by the other, in the spirit of mutual cooperation and support.
It authorizes them to charge the appropriate fees in performance of their respective duties and responsibilities under the Order.
It requires BFAD and BHDT to jointly formulate and agree on the procedure and manner by which each bureau will effectively and efficiently conduct post-market monitoring and surveillance of medical devices.
If any part/term/provision is declared invalid or unenforceable, the rest remains valid and enforceable; the Order is construed as if it did not contain the invalid/unenforceable part. This helps preserve the remaining provisions even if one portion fails.
All other department issuances, bureau circulars, and memoranda inconsistent with the Order are withdrawn, repealed, and/or revoked accordingly.
It shall take effect immediately.
It is signed by the Secretary of Health, Francisco T. Duque III, M.D., MSC. This indicates formal issuance through the proper department head authority.
BHDT provides technical evaluation and recommendations, while the BFAD Director has the final authority to approve and sign certificates/licenses; BHDT’s recommendation alone is insufficient.