The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the highest rates of expenses for document evaluation, analysis, business establishment inspection or medical device inspection monitoring, auditing, or surveillance to control the manufacturing, import, and sale of medical devices. This announcement will be effective after its issuance date in the Royal Gazette.
The highest rate 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 would be determined in the table of expenses 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 Highest Expenses Rates for Document Evaluation, Analysis, Business 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 | 79,000 | |
| 2) Class 3 of Medical Devices | Per item¹ | 55,000 | |
| 3) Class 2 of Medical Devices | Per item¹ | 40,000 | |
| 4) Class 1 of Medical Devices or Veterinary Medical Devices | Per item¹ | 24,000 | |
| 2 | Analysis/Testing of Medical Device2 | ||
| 1) Medical Devices for In Vitro Diagnostics | Per test item³ | Charged according to the unit of examine/analysis | |
| 2) Medical Devices that are Non-In Vitro Diagnostic Devices | 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 | 15,000 | |
| 2) Monitoring, Inspection, or Surveillance of Import Facilities | Per occurrence4 | 15,000 | |
| 3) Monitoring, Inspection, or Surveillance of Sales Facilities | Per occurrence4 | 15,000 |
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 rate calculated from one establishment inspection time per expert per specialty.
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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