The Philippines’ Department of Health (DOH) has recently issued Administrative Order No. 2007-003 which transfers some medical device regulation responsibilities from the Bureau of Food and Drugs (BFAD) to the Bureau of Health Devices and Technology (BHDT). Joint Bureau Memorandum No. 2007-1 was issued on April 23, 2007, clarifying in more detail what this transfer will entail.
The Bureau of Health Devices and Technology (BHDT) was created in 1999. However, the DOH’s concerns of efficiency and capacity have led to new administrative changes to the BHDT.
The BFAD will transfer the following responsibilities to the BHDT:
- Product registration of medical device products listed in BFAD Memorandum Circular No. 7.s. 1992 (http://www.bfad.gov.ph/MC/mc%207%201992.pdf).
- Products include endotracheal tubes, nebulizers, catheters, HIV testing kits, hepatitis testing kits, etc.
- Licensing of a medical device establishment as a distributor.
In the interim, the BFAD will provide on-the-job training to the BHDT. Also, the License to Operate (LTO) a medical device establishment as a manufacturer, trader, repacker, or importer of raw materials will continue to be BFAD’s responsibility until BHDT has the appropriate resources. In addition to training sessions, BHDT will also be involved in inspection of medical device manufacturing plants.
All applications for Certificate of Product Registration (CPR) and License to Operate (LTO) medical device establishments filed before April 30, 2007 will still be processed by the BFAD.
After this date, all applications for CPR and LTO as a distributor should be submitted to the BHDT. However, automatic and regular renewals for CPRs should still be filed to the BFAD.
The BHDT will assign a control number for every application for CPR or LTO. The BHDT will evaluate applications according to the existing guidelines and standards established by the BFAD. Fees will also be based on the schedule set up by the BFAD. The BHDT will prepare the CPR and LTO using the existing format set by the BFAD.
In short, these new responsibilities will simply transfer from the BFAD to the BHDT with no major changes to the current application and review system.