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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