The Food and Drug Administration (FDA) has announced the implementation of a new schedule of fees and charges under Administrative Order No. 2024-0016. For over two decades, the FDA’s fees were governed by Administrative Order No. 50 s. 2001. The restructuring of fees aims to align charges with the costs of regulating health products, establishments, and facilities to ensure consumer safety and public health.
The updated guidelines apply to all establishments, facilities, and health products under FDA jurisdiction, including public and private entities.
The updated guidelines apply to all establishments, facilities, and health products under FDA jurisdiction, including public and private entities.
Revised Fees and Charges for FDA-Regulated Health Products
The following table summarizes the comparison between the old fees under AO No. 50 s. 2001 and the new fees under AO No. 2024-0016 for licenses and certifications under the Center for Device Regulation, Radiation Health, and Research (CDRRHR):
| Category | Old Fees (AO No. 50 s. 2001) | New Fees (AO No. 2024-0016) | Validity |
|---|---|---|---|
| License to Operate (LTO): Medical Device Distributor (Importer/Exporter/Wholesaler) | |||
| Initial Application Fee | Php 4,000.00 (valid for 1 year) | Php 8,500.00 per year validity | 3 years (Micro/Small), 6 years (Medium/Large) |
| Renewal Fee | Php 8,000.00 (valid for 2 years) | Php 8,500.00 per year validity | 6 years (Micro/Small), 12 years (Medium/Large) |
| Variation Application - Minor Change | Php 500.00 per change | Php 1,600.00 | - |
| Variation Application - Major Change | Not specified | Php 13,200.00 | - |
| License to Operate (LTO): Medical Device Retailer | |||
| Initial Application Fee | Php 2,000.00 (valid for 2 years) | Php 3,000.00 per year validity | 3 years (Micro/Small), 6 years (Medium/Large) |
| Renewal Fee | Php 3,000.00 (valid for 3 years) | Php 3,000.00 per year validity | 6 years (Micro/Small), 12 years (Medium/Large) |
| Variation Application - Minor Change | Php 500.00 per change | Php 620.00 | - |
| Variation Application - Major Change | Not specified | Php 3,000.00 | - |
| In-Vitro Diagnostics (IVD) | |||
| Initial Application Fee | Php 1,500.00 (valid for 1 year) | Php 17,700.00 per year validity | CPR: 6 years |
| Renewal Fee | Php 5,000.00 (valid for 5 years) | Php 15,400.00 per year validity | CPR: 6 or 12 years |
| Variation Application - Minor Change | Php 510.00 per change/certificate | Php 3,000.00 | - |
| Variation Application - Major Change | Not specified | Php 4,000.00 | - |
| CIVDR Class A (Registration) | Not applicable | Initial: Php 13,500.00 per year validity | CPR: 6 years |
| Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | ||
| CIVDR Class D (Registration) | Not applicable | Initial: Php 19,500.00 per year validity | CPR: 6 years |
| Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | ||
| Certificate of Medical Device Notification (CMDN): Class A | Php 1,500.00 per year | Initial: Php 13,500.00 per year validity | CPR: 6 years |
| Php 1,010.00 per year | Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | |
| Certificate of Medical Device Registration (CMDR): Class B | Php 1,500.00 per year | Initial: Php 18,000.00 per year validity | CPR: 6 years |
| Php 1,010.00 per year | Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | |
| Certificate of Medical Device Registration (CMDR): Class C | Php 1,500.00 per year | Initial: Php 18,500.00 per year validity | CPR: 6 years |
| Php 1,010.00 per year | Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | |
| Certificate of Medical Device Registration (CMDR): Class D | Php 1,500.00 per year | Initial: Php 19,500.00 per year validity | CPR: 6 years |
| Php 1,010.00 per year | Renewal: Php 15,300.00 per year validity | CPR: 6 or 12 years | |
| Other Certifications | |||
| CPR Reapplication Fee - Class A | Php 9,450.00 | Php 9,450.00 | - |
| CPR Reapplication Fee - Class B | Php 12,600.00 | Php 12,600.00 | - |
| CPR Reapplication Fee - Class C | Php 12,950.00 | Php 12,950.00 | |
| CPR Reapplication Fee - Class D | Php 13,650.00 | Php 13,650.00 | - |
| Compassionate Special Permit | Php 500.00 | Php 500.00 | One-time use |
| Certificate of Free Sales | Php 510.00 | Php 1,650.00 | - |
| Certificate of Medical Device Listing | Php 1,500.00 | Php 3,400.00 | - |
| Sales Promo Permit | Php 510.00 | Php 1,000.00 | - |
| Pre-assessment Fee | Not applicable | Php 500.00 (deductible from registration) | - |
Implementation Timeline
- This regulation will take effect 15 days after official publication in newspapers of general circulation.
- As of this writing, the AO has not yet been officially published.
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