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01 e Change in Circumstances
01 e Change in Circumstances
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
a. For Manufacturer/Re-packer
i. Letter of intent regarding the application for the change of business address
ii. Notarized Electronic Copy (E-copy) Affidavit
iii. Business Name Registration reflecting new address
1. For single proprietorship, registration from the Department of Trade &
Industry
2. For corporation/partnership, registration from the Securities & Exchange
Commission (SEC) and Articles of Incorporation
3. Mayor’s permit/Business permit to verify the specific address, in case the
DTI or SEC registration does not indicate the specific location or address of
the office.
iv. Notarized and valid contract of lease or any proof of ownership for the new office
and/or storage facility/warehouse.
v. Location map of the new office and/or storage facility/warehouse
vi. Floor plan of the new office and/or storage facility/warehouse (with dimensions)
vii. Amended Agreement with the toll manufacturer and/or toll re-packer reflecting the
new office address OR acknowledgement letter by the toll manufacturer and/or toll
re-packer regarding the change of address.
viii. Original copy of the LTO
ix. Re-issuance Fee
b. For Importer/Wholesaler/Exporter/Trader
i. Letter of intent regarding change of business address
ii. Notarized Accomplished Petition Form and Joint Affidavit of Undertaking
iii. Photocopy of Business Name Registration
1. If Single proprietorship – Copy of DTI Certificate reflecting the new business
address
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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-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
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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-01E
Revision No. 2
Date Effective: 15 April 2015
g. Amendment fee
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 manufacturer’s or re-packer’s LTO.
b. Valid LTO of the trader
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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-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 trader’s LTO.
b. Valid LTO of the toll manufacturer or toll re-packer
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