In the Philippines, all foreign medical devices are required to undergo the same registration procedure, regardless of whether they are previously registered in other countries. The Bureau of Food & Drug Administration (BFAD) under the Department of Health of the Philippines is the primary regulatory organization. Additionally, radiation-emitting devices must be registered with the Department of Health's Radiation Health Office. Contact information for the BFAD is provided below.
BFAD has issued the following checklist of requirements for invasive medical device registration. Applicants for registration must provide:
A letter of application from the manufacturer or trader or distributor;
A valid License to Operate (to be procured by the local representative agent in the case of a foreign manufacturer);
A governmental certificate of product clearance and free sale (or registration) for the product from its country of origin. Such a certificate (e.g., the USFDA's CFG) also must be authenticated by a Philippine consulate in the country of origin;
A governmental certificate attesting to the status of manufacturer, including the competency and reliability of its personnel and facilities. This also must be duly authenticated by a Philippine consulate in the country of origin;
A certificate of agreement between the manufacturer and local Philippines distributor/importer regarding the product involved;
The product's suggested retail price;
A list of amounts and technical specifications of all raw materials of which the product is comprised;
A brief description of the methods used, the facilities and control in the manufacture, processing and packaging of the product;
Complete quality control procedures for the finished product;
Technical specifications and physical description of the finished product;
(where applicable): Stability studies of the product, establishing the claimed expiration date;
Unattached labels or proposed labels and other labeling materials to be used for the product in the Philippines;
A representative sample or commercial presentation of the product as marketed in the Philippines; and
Proof of payment of the registration fee (i.e., official receipt from the BFAD cashier).
A certificate for Non-Registrable Product may be obtained if the medical device in question does not fall subject to BFAD regulations. However, companies must submit the product description and brochure to BFAD in order for an assessment of registrability.
of Health of the Philippines:
Appendix 1: For more information, read the following 2005 Commercial Service Reports.
Last updated on 12-20-05 by JF
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