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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-01E
Revision No. 2
Date Effective: 15 April 2015
Page 1 of 4
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-01E
Revision No. 2
Date Effective: 15 April 2015
3. CHANGE OF OWNERSHIP
a. Letter of intent regarding the application for the change of ownership
b. All the requirements in opening application
c. Notarized Transfer of Rights or Deed of Sale of the business/establishment (if applicable)
d. Original copy of the LTO
e. Opening fee
4. CHANGE OF PHARMACIST
a. Notarized Form of Notice of Change of Pharmacist
b. Board registration certificate, valid PRC-ID, valid PTR, duties and responsibilities.
c. (2)ID pictures of the incoming regulatory officer.
d. Certificate of attendance to an FDA seminar on Licensing of Medical Device distributors
attended by the incoming regulatory officer
e. Resignation of the incoming regulatory officer from the previous employment
5. RECLASSIFICATION
a. Letter of intent regarding the inclusion of additional classification
b. Original License to Operate (LTO)
c. Re-issuance fee
i. If Importer
1. Foreign agency Agreement from each supplier duly authenticated by the territorial
Philippine Consulate
2. Certificate of Registration of manufacturer/s and its conformity with GMP from
Health Authority
ii. If Wholesaler
1. A valid contract with FDA licensed supplier
2. Certification that the product it sells are registered with FDA
3. License to Operate of the supplier
iii. If Exporter
1. A valid contract with FDA licensed supplier
2. Certification that the product it sells are registered with FDA
Page 2 of 4
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-01E
Revision No. 2
Date Effective: 15 April 2015
9. ADDITIONAL PRODUCT(S)
a. Letter of intent regarding the application for the addition of product
b. Notarized electronic copy (e-copy) affidavit
c. List of new products
d. Original copy of the LTO
e. Amendment fee
a. Valid Agreement with the trader or amended Agreement for the addendum of the new
product if the trader is already listed in the manufacturers or re-packers LTO.
b. Valid LTO of the trader
Page 3 of 4
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-01E
Revision No. 2
Date Effective: 15 April 2015
For Traders:
a. Valid Agreement with the toll manufacturer or toll re-packer or amended Agreement for
the addendum of the new product if the toll manufacturer or re-packer is already listed
in the traders LTO.
b. Valid LTO of the toll manufacturer or toll re-packer
Page 4 of 4