The Thai Food and Drug Administration (FDA) has officially announced the rates for expenses related to monitoring, auditing, and surveillance activities aimed at ensuring compliance with medical device regulations. This new fee structure, effective from November 13 2024, addresses expenses for document evaluation, testing, facility inspections, and related activities to control the manufacturing, importation, and sale of medical devices.
The regulation outlines maximum allowable rates for these activities, providing clear guidance to stakeholders while reinforcing safety and compliance within the medical device industry.
The regulation outlines maximum allowable rates for these activities, providing clear guidance to stakeholders while reinforcing safety and compliance within the medical device industry.
Effective Dates and Review Schedule
- Implementation of Rates: Effective 90 days after publication in the Royal Gazette.
- Maximum Allowable Rates: Effective the day after publication in the Royal Gazette.
- Review Frequency: The Thai FDA will review these expenses every five years or as deemed necessary.
Summary of Fees for Items
| No | Items/Topics | Unit | Rate of Expenses (Baht) | Maximum Rate Allowed (Baht) |
|---|---|---|---|---|
| 1 | Document Evaluation for Medical Devices Requiring Expert Review | |||
| 1) Class 4 Medical Devices | Per item1 | 30,000 | 79,000 | |
| 2) Class 3 Medical Devices | Per item1 | 23,000 | 55,000 | |
| 3) Class 2 Medical Devices | Per item1 | 23,000 | 40,000 | |
| 4) Class 1 Medical Devices or Veterinary Medical Devices | Per item1 | 14,000 | 24,000 | |
| 2 | Analysis/Testing of Medical Device2 | |||
| 1) Medical Devices for In Vitro Diagnostics5 | ||||
| • Immunology and Chemistry Test | Per test topic3 | Charged according to the testing authority and must not exceed the maximum rate | 500,000 | |
| • Molecular Testing such as Nucleic Acid Testing [Quantitative, Qualitative, Sequencing] | Per test topic3 | 500,000 | ||
| • Sterility Test | Per test topic3 | 10,000 | ||
| • Physical Test | Per test topic3 | 20,000 | ||
| • Microbiology Test | Per test topic3 | 20,000 | ||
| • Electrical and Electronic Testing | Per test topic3 | 300,000 | ||
| • Medical Software Testing | Per test topic3 | 100,000 | ||
| 2) Medical Devices that are Non-In Vitro Diagnostic Devices5 | ||||
| • Sterility Test | Per test item3 | Charged according to the testing authority and must not exceed the maximum rate | 10,000 | |
| • Biocompatibility Testing | Per test item3 | 1,600,000 | ||
| • Physical Testing | Per test item3 | 20,000 | ||
| • Chemical Testing | Per test item3 | 20,000 | ||
| • Microbiology Testing | Per test item3 | 20,000 | ||
| • Electrical and Electronic Testing | Per test item3 | 300,000 | ||
| • Medical Software Testing | Per test item3 | 100,000 | ||
| 3 | Inspection of Medical Device Establishments Requiring Expert Review | |||
| 1) Monitoring, Inspection, or Surveillance of Production Facilities | Per inspection4 | 14,000 | 15,000 | |
| 2) Monitoring, Inspection, or Surveillance of Import Facilities | Per inspection4 | 14,000 | 15,000 | |
| 3) Monitoring, Inspection, or Surveillance of Sales Facilities | Per inspection4 | 14,000 | 15,000 | |
Remarks:
“1” refers to the expense per item per sample group.
“2” requires registrants of establishments, license, notified certificates, manufacturers, importers, or sellers of medical devices to pay the expenses directly to the testing unit/authority.
“3” refers to the expense per testing topic per sample group.
“4” refers to the rate calculated per inspection of an establishment per expert specialty.
“5” refers to the In-Vitro Diagnostics medical devices of humans and animals.
“1” refers to the expense per item per sample group.
“2” requires registrants of establishments, license, notified certificates, manufacturers, importers, or sellers of medical devices to pay the expenses directly to the testing unit/authority.
“3” refers to the expense per testing topic per sample group.
“4” refers to the rate calculated per inspection of an establishment per expert specialty.
“5” refers to the In-Vitro Diagnostics medical devices of humans and animals.
Access Full Details and Guidance
For the official article and complete details on the new fee structure, visit the Thai FDA website here.
For inquiries or assistance regarding compliance with these new regulations, please contact us at sales@andamanmed.com or click the button below for expert support.