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Republic of the Philippines

Department of Health
Food and Drug Administration
CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH
(former name : Bureau of Health Devices and Technology)
LICENSING AND REGISTRATION DIVISION
CDRRHR-2-L-01CRevision No. 2
Date Effective: 15 April 2015

CHECKLIST OF REQUIREMENTS FOR OPENING AN ESTABLISHMENT AS


MEDICAL DEVICE IMPORTER/ WHOLESALER/EXPORTER
GENERAL REQUIREMENTS
1.) Notarized Application Form and Joint Affidavit of Undertaking
2.) Notarized Electronic Copy (E-copy) Affidavit
3.) List of Medical Devices to be Imported/Distributed
4.) Photocopy of the Pharmacists Board Registration Certificate, PRC-ID, valid PTR, Duties
and Responsibilities, Certificate of Attendance of Owner/Pharmacist to an FDA/BFAD
Seminar on Licensing of Drug/Medical Device Establishments and Outlets
5.) Location Plan and Floor Plan (office and storage room/warehouse) with dimensions
6.) Photocopy of the Business Name Registration
a.) If single proprietorship, registration from the Department of Trade and Industry
b.) If corporation/partnership, registration from the Securities and Exchange Commission
(SEC) and Articles of Incorporation
7.) ID pictures of the Owner/Authorized Representative and Pharmacist (not computer
generated)
8.) Photocopy of Notarized 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 with each supplier/source 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 or valid ISO Certification for Medical Device. Should be
duly authenticated by the Territorial Philippine Consulate.
B. If WHOLESALER:
1.) Notarized valid Contract/Agreement with each FDA (BFAD) licensed
supplier/manufacturer
2.) Copy of the License to Operate (LTO) of the contracted manufacturer/supplier
3.) Copy of the Certificate of the Product Registration to be distributed
C. If EXPORTER:
1.) Notarized valid Contract/Agreement with each FDA (BFAD) licensed
supplier/manufacturer
2.) Copy of the License to Operate (LTO) of the contracted manufacturer/supplier
3.) Copy of the Certificate of the Product Registration to be distributed
NOTE:
In addition to the hard copy of the above-mentioned standard requirements, the client shall also
submit an electronic/scanned copy (in PDF searchable format at least 300dpi) on a DVD-R of the
application
The above-stated requirements shall be properly labeled with table of contents indicating the
number of pages, divider with ear tags, and place in a White Data Folder.