FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH

LICENSING and REGISTRATION DIVISION

LICENSE TO OPERATE:CHECKLIST OF REQUIREMENTS FOR OPENING AN ESTABLISHMENT AS MEDICAL DEVICE IMPORTER/WHOLESALER/EXPORT ER

Document No.: Revision No. Date Effective: Page:

011-004-L-01C 0 6 August 2012 1 of 1

GENERAL REQUIREMENTS 1. Accomplished Notarized Petition Form and Joint Affidavit of Undertaking 2. List of Medical Devices to be imported/distributed 3. Photocopy of the Pharmacist’s Board Registration Certificate; PRC-ID; valid PTR; ID picture; Duties and Responsibilities of the Pharmacist; Certificate of attendance of Owner/Pharmacists to a FDA/BFAD seminar on Licensing of Drug/Medical Device Establishments and outlets 4. Location plan and floor plan (office and storage room/warehouse) with dimensions 5. Photocopy of the Business Name Registration a. If single proprietorship, registration from the Department of Trade & Industry b. If corporation/partnership, registration from Securities & Exchange Commission (SEC) and Articles of Incorporation 6. ID pictures of the Owner/ Authorized Representative and Pharmacist (size: 5cm x 5 cm) 7. Photocopy of notarized valid Contract of Lease for the space of the office and storage to be occupied or any proof of ownership if it is owned by the applicant ADDITIONAL REQUIREMENTS A. If IMPORTER : 1. Foreign agency agreement from each supplier duly authenticated by the Territorial Philippine Consulate 2. Certificate of Registration of the Manufacturer and its conformity with GMP issued by a Government Health Authority/valid ISO Certification for Medical device B. If WHOLESALER 1. Notarized valid Contract/Agreement with FDA(BFAD) licensed supplier/manufacturer 2. Certified True Copy of the License to Operate (LTO) of the contracted manufacturer/supplier 3. Copies of Certification that the product it sells are registered with FDA(BFAD) C. If EXPORTER 1. Notarized valid Contract/Agreement with FDA(BFAD) licensed supplier/manufacturer 2. Certified True Copy of the License to Operate (LTO) of the contracted manufacturer/supplier 3. Copies of Certification that the product it sells are registered with FDA(BFAD)
*Fees to be paid (Based on A.O. 50 s. 2001): Php 4,000.00 ** Must be presented upon inspection: Batch Distribution Record Book