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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

CHECKLIST OF REQUIREMENTS FOR CHANGES IN CIRCUMSTANCES OF


A MEDICAL DEVICE ESTABLISHMENT
1. CHANGE OF BUSINES NAME
a. Letter of intent regarding change of business name
b. Notarized Accomplished Petition Form and Joint Affidavit of Undertaking
c. Photocopy of Business Name Registration
i. If Single proprietorship Copy of DTI Certificate reflecting the new business name
ii. If corporation/partnership - Copy of registration from Securities & Exchange Commission
(SEC) and Articles of Incorporation reflecting the new business name
d. Photocopy of Contract of Lease (if leased) reflecting the new business name
e. Original License to Operate (LTO)
f. Amended agreement with the supplier(s)
g. Re-issuance fee

2. CHANGE OF BUSINESS ADDRESS


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. Mayors 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
2. If corporation/partnership - Copy of registration from Securities & Exchange
Commission (SEC) and Articles of Incorporation reflecting the new business
address
iv. Photocopy of Contract of Lease (if leased) 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

v. Original License to Operate (LTO)


vi. Amended agreement with the supplier(s)
vii. Letter received by supplier(s) informing the change of address
viii. Re-issuance fee

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

6. Additional toll manufacturer and/or toll re-packer


a. Letter of intent regarding the application for the addition of toll manufacturer/re-packer
b. Notarized electronic copy (e-copy) affidavit
c. List of the products to be manufactured/re-packed
d. Original copy of the LTO
e. Valid Agreement with the new toll manufacturer or toll re-packer
f. Valid LTO of the new toll manufacturer or toll re-packer
g. Amendment fee

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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

7. Deletion of product, trader, manufacturers, re-packer, activity


a. Request letter to delete the product, trader, manufacturers, re-packer or activity
b. Original License to Operate of the Manufacturer
c. Amendment fee

8. ADDITIONAL SOURCE AND/OR CHANGE OF NAME OF SOURCE


a. Letter of intent
b. Amendment 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 list of products/raw materials

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

For Manufacturers or Traders that will import the raw materials:


a. Valid Agreement with the foreign supplier of the raw materials duly authenticated by
the territorial Philippine Consulate.

For Re-packers that will import the new product to be re-packed:


a. valid Agreement with the foreign supplier of the new product (finished medical device
in bulk) duly authenticated by the territorial Philippine Consulate and the certificate of
conformity with GMP or ISO certification for QMS or EC certificate for quality
assurance of the manufacturer of the finished medical device in bulk

For Toll Manufacturers and Toll Re-packers:

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

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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 traders LTO.
b. Valid LTO of the toll manufacturer or toll re-packer

10. ADDITIONAL ACTIVITY


i. For the importation of raw materials or finished medical device in bulk
a. Letter of intent regarding the application for the addition of activity
b. Notarized electronic copy (e-copy) affidavit
c. Original copy of the LTO
d. Valid Agreement with the foreign supplier of the raw materials or finished medical device
in bulk duly authenticated by the territorial Philippine Consulate
e. Valid Certificate of conformity with GMP or ISO certification for QMS or EC certificate
for quality assurance of the manufacturer of the finished medical device in bulk
f. Amendment fee
ii. For the exportation of own product
a. Letter of intent regarding the application for the addition of activity
b. Notarized Electronic Copy (e-copy) Affidavit
c. Original copy of the LTO
d. List of products to be exported
e. Amendment fee

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