FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH

LICENSING and REGISTRATION DIVISION

Document No.:

011-004-R-01A 0 6 August 2012 1 of 1

CHECKLIST OF REQUIREMENTS FOR CERTIFICATE OF PRODUCT REGISTRATION OF MEDICAL DEVICES

Revision No. Date Effective: Page:

REQUIREMENTS 1. Notarized letter of Application from Manufacturer/ Trader/Distributor 2. Valid License to Operate (LTO) of Manufacturer/ Trader Importer/Distributor/Wholesaler 3. Government Certificate of Clearance and Free Sale/Registration approval of the product from the country of origin issued by the Of the Product from the country of origin issued by the Health Authority and duly authenticated by the territorial Philippine Consulate for Imported Product (Present original copy for verification) 4. Government Certificate attesting to the status of the manufacturer, competency and reliability of the personnel and facilities and duly authenticated by the territorial Philippine Consulate and/or valid ISO Certification for Imported Product(Present original copy for verification) 5. Certificate of agreement between the manufacturer and trader/distributor/importer regarding the product involved 6. Specific Use and Directions for Use 7. Copy of latest Certificate of Product Registration 8. List of all raw materials used as component of the product and its technical specifications. Shall include complete list of names and quantities, detailed information on physical and chemical properties of each component. 9. Brief description of the methods used the facilities and control in the manufacture, processing and packaging of the product. For sterile products, include sterilization standard parameters, sterilization procedures, validation protocol, results of latest sterilization protocol and test data and results of the latest sterility tests. For non-sterile, include declaration from the manufacturer why the device is non-sterile. If the sterilization of the device was contracted out, submit copy of valid ISO of the contracted sterilizing company. 10. Technical specifications and physical description of the Finished Product. Submit also following : (a) Functionality/performance test data & results conducted on the finished product; (b)Test data and results of the Biocompatibility test; (c) Risk management of the device, where applicable 11. Stability studies of the product to justify claimed expiration date, where applicable 12. Labeling materials to be used for the product : Immediate label, box label and package insert /brochure, if applicable 13. Representative sample in the market or commercial presentation (submit one of each size) 14. Evidence of registration fee/ payment (charge slip/official receipt)

TYPE of APPLICATION INITIAL RENEWAL

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