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).

ProductCurrent Fees (PHP)* Per YearProductProposed New Fees (PHP)* Per Year
Initial (1 year)Renewal (5 years)Initial**Renewal**
In-Vitro Diagnostics1,5005,000CIVDR 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 Device1,500CMDN Class A13,500
Class B Medical Device1,500CMDN Class B18,00015,300
Class C Medical Device1,500CMDR Class C18,50015,300
Class D Medical Device1,500CMDR Class D19,50015,300
Certificate of Medical Device Listing (CMDL)500 / ApplicationCertificate of Medical Device Listing (CMDL)3,400
CPR/CMDR/CMDN Amendment or Variations500 per product, per changeCPR/CMDR/CMDN Minor Variations3,000 per product, per change
CPR/CMDR/CMDN Minor Variations4,000 per product, per change
CPR/CMDR re-application10,000CPR/CMDR re-application2,800
Compassionate Special500Compassionate Special Permit1,200

* 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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