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CHECKLIST OF REQUIREMENTS FOR MEDICAL DEVICE & COSMETIC DISTRIBUTOR

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Undergoing MyBlogLog Verification
CHECKLIST OF REQUIREMENTS FOR MEDICAL DEVICE & COSMETIC DISTRIBUTOR
- Accomplished Notarized Petition Form/Joint Affidavit of Undertaking
- List of Medical Device/Cosmetic Products to be importer/distributed
- Copies of Pharmacist Board Registration Certificate, PRC-ID, valid PTR, ID picture, Duties and Responsibilities, Certificate of Attendance of Owner/Pharmacist to a BFAD seminar on Licensing of Drug Establishments and Outlets
- Location Plan and Floor Plan (Office and Storage Room) with dimensions.
Photocopies of the following:
- If corporation, Registration Certificate with SEC and Articles of Incorporation or Partnership
- If single proprietorship, Certificate of Business Name Registration with Bureau of Trade Regulation
and Consumer Protection (BTRCP)
- Contract of Lease for the space of the office and storage to be occupied or any proof ownership if it is owned by the applicant.

If Importer:
- Foreign Agency Agreement from each supplier duly authenticated by the Territorial
Philippine Consulate
- Certificate of Registration of manufacturer and its conformity with GMP From Health
Authority/ISO Certification for medical device

If Wholesaler:
- A Valid contract with BFAD licensed supplier/manufacturer
- Certification that the product it sells are registered with BFAD
- LTO of manufacturer/supplier

If Exporter:
- A Valid contract with BFAD licensed supplier/manufacturer
- Certification that the product it sells are registered with BFAD
- LTO of manufacturer/supplier

Fees to be paid (Based on A.O. 50 s. 2001
- Medical Device Distributor - P 4,000.00
- Cosmetic Distributor - P 3,000.00

Must be presented upon inspection:
o Copies of R.A. 5921 and R.A. 3720 as amended
o Batch Distribution Record Book

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2 comments:
gravatar
wins said...
August 18, 2009 at 12:21 AM  

hi! i have a question...

can we hire the services of a pharmacist for the purpose of filing a BFAD LTO only? my friend is planning to start up a company which will distribute dental supplies.

would really appreciate your response. thanks!

gravatar
admin said...
August 19, 2009 at 8:11 AM  

Although we do not encourage this, yes you can do that. But Pharmacist must be in the office everytime your company is open for business. Once you are inspected without pharmacist, you will be penalized for suspension or worst yet revocation of your LTO.

Thank you,
PinoyPharmacist

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