Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

The Philippines Food and Drug Administration held a virtual public consultation on the draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services”, October 27th 2023.

The aim of the proposed draft issuance is to rationalize the fee structure of the FDA to further strengthen the agency in the exercise of its mandate of regulating health products and establishments under its jurisdiction. 

The proposed new schedule of fees and charges of FDA shall apply to all persons, establishments or facilities and health products that are under FDA’s jurisdiction whether public or private entities.

The table below shows the comparison of the Medical Device Registration fees (Current Vs. Proposed).

Product Current Fees (PHP)* Per Year Product Proposed New Fees (PHP)* Per Year
Initial (1 year) Renewal (5 years) Initial** Renewal**
In-Vitro Diagnostics 1,500 5,000 CIVDR Class A (Registration) 14,500
CIVDR Class B (Registration) 19,400
CIVDR Class C (Registration) 20,000
CIVDR Class D (Registration) 20,400
Class A Medical Device 1,500 CMDN Class A 13,500
Class B Medical Device 1,500 CMDN Class B 18,000 15,300
Class C Medical Device 1,500 CMDR Class C 18,500 15,300
Class D Medical Device 1,500 CMDR Class D 19,500 15,300
Certificate of Medical Device Listing (CMDL) 500 / Application Certificate of Medical Device Listing (CMDL) 3,400
CPR/CMDR/CMDN Amendment or Variations 500 per product, per change CPR/CMDR/CMDN Minor Variations 3,000 per product, per change
CPR/CMDR/CMDN Minor Variations 4,000 per product, per change
CPR/CMDR re-application 10,000 CPR/CMDR re-application 2,800
Compassionate Special 500 Compassionate Special Permit 1,200

* All fees are subject to an additional 1% for Legal Research Fee (LRF)

** The validity for both initial and renewal applications of authorizations shall be referred to in a separate issuance.

For the complete list of proposed fees and charges for Medical Devices and the draft Administrative Order, please refer to this link [insert link to the attachment files named “Annex-Cost-Computations-1” and “Draft-AO-on-the-Revision-of-FDA-Fees-and-Charges”]

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