The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the expenses for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device manufacturing, import, and sale. This announcement will be effective 90 days after issuance in the Royal Gazette.
The expenses for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device manufacturing, import, and sale would be determined in the expenses table as an annexure, as shown below. This table of expenses as an annexure shall be reviewed every 5 years or depending on other necessary reasons.
Annexure: Table of Expenses for Document Evaluation, Analysis, Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices.
| No. | Items | Unit | Rate of Expenses (Baht) |
|---|---|---|---|
| 1 | Document Evaluation for Medical Devices Requiring Expert Review | ||
| 1) Class 4 of Medical Devices | Per item¹ | 30,000 | |
| 2) Class 3 of Medical Devices | Per item¹ | 23,000 | |
| 3) Class 2 of Medical Devices | Per item¹ | 23,000 | |
| 4) Class 1 of Medical Devices or Veterinary Medical Devices | Per item¹ | 14,000 | |
| 2 | Analysis/Testing of Medical Device2 | ||
| 1) Medical Devices for In Vitro Diagnostics • Immunology and Chemistry Test • Molecular Testing such as Nucleic Acid Testing [Quantitative, Qualitative, Sequencing] • Sterility Test • Physical Test • Microbiology Test • Electrical and Electronic Testing • Medical Software Testing • Culture Testing • Staining Method Testing • Cell Counting Method Testing • Other Related Tests as Specified | Per test item³ | Charged according to examine/analysis center, but not more than the maximum rate as specified in announcement* | |
| 2) Medical Devices that are Non-In Vitro Diagnostic Devices • Sterility Test • Biocompatibility Testing • Physical Testing • Chemical Testing • Microbiology Testing • Electrical and Electronic Testing • Medical Software Testing • Other Related Testing beyond the Specified | Per test item³ | ||
| 3) Veterinary Medical Devices | Per test item³ | ||
| 3 | Inspection of Medical Device Establishments Requires Expert Review | ||
| 1) Monitoring, Inspection, or Surveillance of Production Facilities | Per occurrence4 | 14,000 | |
| 2) Monitoring, Inspection, or Surveillance of Import Facilities | Per occurrence4 | 14,000 | |
| 3) Monitoring, Inspection, or Surveillance of Sales Facilities | Per occurrence4 | 14,000 |
Notes:
1) “1” means the expense per item per one sample group.
2) “2” means registrants of establishments, licenses, notified certificates, manufacturers, importers, or sellers of medical devices have to pay the expenses directly to the analysis/testing center.
3) “3” means the expense per testing item/analysis per sample group.
4) “4” means the rate calculated from one establishment inspection time per expert per specialty.
5) “*” means The Ministry of Public Health’s announcement on the maximum rates for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device production, import, and sale.
Further information of this draft announcement can be accessed here (in Thai)
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.
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