Checklist of Requirements for Lto Importer_wholesaler (1)

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.:

011-004-L-01C

Revision No.

0

Date Effective:

6 August 2012

Page:

1 of 1

GENERAL REQUIREMENTS REQUIREMENTS 1. Accomplishe Accomplished d Notarized Notarized Petition Petition Form Form and Joint Joint Affidavi Affidavitt of Undertakin Undertaking g 2. List List of Medical Medical Device Devicess to be imported imported/di /distri stribut buted ed 3. Photoc Photocopy opy of the Pharmac Pharmacist ist’s ’s Board Board Registrat Registration ion Certifica Certificate; te; PRC-ID; PRC-ID; valid valid PTR; PTR; ID  picture; Duties and Responsibilities of the Pharmacist; Certificate of attendance of  Owner/P Owner/Phar harmac macists ists to a FDA/BF FDA/BFAD AD semina seminarr on Licensi Licensing ng of Drug/M Drug/Medi edical cal Device Device Establishments and outlets 4. Location Location plan and floor floor plan (office (office and storage storage room/ room/wareho warehouse) use) with dimensions dimensions 5. Photoc Photocopy opy of of the Busin Business ess Name Name Regis Registrat tration ion a. If  single proprietorship regist strat ratio ion n from from the the Depa Departm rtmen entt of Trad Tradee & proprietorship, regi Industry regist stra rati tion on from from Secu Securi riti ties es & Exch Exchan ange ge  b. If  corporation/partnership, regi Commission (SEC) and Articles of Incorporation 6. ID pictures pictures of the the Owner/ Autho Authorized rized Represent Representative ative and and Pharmacist Pharmacist (size: (size: 5cm x 5 cm) cm) 7. Photocopy Photocopy of of notarized notarized valid Contra Contract ct of Lease for for the space of of the office office and storage storage to  be occupied or any proof of ownership ownership if it is owned by the applicant ADDITIONAL REQUIREMENTS REQUIREMENTS IMPORTER : A. If  IMPORTER 1. Foreign Foreign agency agreement agreement from each each supplier supplier duly duly authenticate authenticated d by the Territo Territorial rial Philippine Consulate 2. Certificate Certificate of Registrati Registration on of the the Manufacturer Manufacturer and and its conformi conformity ty with GMP GMP issued by a Government Health Authority/valid ISO Certification for Medical device

B. If  WHOLESALER  WHOLESALER  1. Notarized Notarized valid Contract Contract/Agreem /Agreement ent with FDA(BFA FDA(BFAD) D) licensed licensed supplier/man supplier/manufactu ufacturer  rer  2. Certified Certified True Copy of the License License to to Operate Operate (LTO) (LTO) of the the contracted contracted manufacturer/supplier  3. Copies Copies of Certificatio Certification n that the produ product ct it sells are register registered ed with FDA(BF FDA(BFAD) AD) EXPORTER  C. If  EXPORTER  1. Notarized Notarized valid Contract Contract/Agreem /Agreement ent with FDA(BFA FDA(BFAD) D) licensed licensed supplier/man supplier/manufactu ufacturer  rer  2. Certified Certified True Copy of the License License to to Operate Operate (LTO) (LTO) of the the contracted contracted manufacturer/supplier  3. Copies Copies of Certificatio Certification n that the produ product ct it sells are register registered ed with FDA(BF FDA(BFAD) AD) *Fees to be paid (Based on A.O. 50 s. 2001): Php 4,000.00 ** Must be presented upon inspection: Batch Distribution Record Book