On October 2, 2024, the Thai FDA published an infographic on its official website about the Renewal, Termination, and Non-Renewal of five (5) Thai FDA Licenses applicable for local importers and manufacturers. The steps to be taken are as follows:
- Download the forms from the Medical Device Control Division’s website.
- Register for an OPEN ID Username & Password.
- Submit a request for access to SKYNET FDA.
- Submit the application and check the information on the website, then pay by December 31 of the year the license expires.
- Receive the renewed license through the SKYNET FDA system.
The following table summarizes the key information for the mentioned processes:
Thai FDA Licenses | ||||||
---|---|---|---|---|---|---|
Type | Purpose | Establishment License | Certificate of Licensed | Certificate of Notified | Certificate of Listed | Sales License |
Renewal | License Validity | 5 years from the approval year | 5 years from the approval date | 1 year from approval | ||
Renewal Period | Renewal system opens Oct 1 – Dec 31 | Renew before the license expires | Renewal system opens Oct 1 – Dec 31 | |||
Fees | Evaluation Fee–THB | 12,000 | – | – | – | 3,000 |
Renewal Fee – THB (Local Production) | 2,000 | 10,000 | 5,000 | 500 | 1,000 | |
Renewal Fee – THB (Import) | 4,000 | 20,000 | 10,000 | 1,000 | 1,000 | |
Late Fees | Fine (THB per day) | 500 | 1,000 | 500 | 1,000 | 1,000 |
Late Renewal Submission | Must apply within 1 month after expiration with a valid reason for late submission. | |||||
Expired License | The license is invalid and cannot be renewed after expiration |
For Business Termination/Non-Renewal Notification, the establishment must notify within 30 days of business termination or license expiration following the requirements below:
Type | Punishment | Requirement | ||
---|---|---|---|---|
Fine up to 5,000 THB | Fine up to 10,000 THB | Business termination | No-renewal | |
1. Establishment license | ✓ | form Lor Por.1 with relevant documents | form Lor Por.2 with relevant documents | |
2. Sales license | ✓ | form Lor Por.1 with relevant documents | form Lor Por.2 with relevant documents | |
3. Certificate of Licensed/ Notified | ✓ | form Lor Por.1 with relevant documents | form Lor Por.2 with relevant documents | |
Submit production / import/ sales report (as applicable) | Submit production / import/ sales report (as applicable) | |||
4. Certificate of Listed | ✓ | form Lor Por.1 with relevant documents | form Lor Por.2 with relevant documents | |
Submit production / import/ sales report (as applicable) | Submit production / import/ sales report (as applicable) |
Furthermore, Thai FDA shares the guidelines after Termination/No-Renewal:
- Remaining medical devices must be sold to another licensed party within 60 days of business termination or license expiration.Sales after the extended period result in penalties of imprisonment for up to 2 years or a fine of up to 200,000 THB, or both.
- Submit form Lor Por.3 to declare the amount and storage location of the remaining medical device within 15 days after 60 days as above. (If violated, a fine of up to 10,000 baht will be imposed).
For more information about this infographic, refer to the following link: กองควบคุมเครื่องมือแพทย์
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