Regulatory Affairs Update: Thailand

Thailand: Thai FDA Infographic Shares the Process Regarding Renewal, Termination and Non-Renewal of Several Thai FDA Licenses

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:

  1. Download the forms from the Medical Device Control Division’s website.
  2. Register for an OPEN ID Username & Password.
  3. Submit a request for access to SKYNET FDA.
  4. Submit the application and check the information on the website, then pay by December 31 of the year the license expires.
  5. Receive the renewed license through the SKYNET FDA system.

The following table summarizes the key information for the mentioned processes:

Thai FDA Licenses
TypePurposeEstablishment LicenseCertificate of LicensedCertificate of NotifiedCertificate of ListedSales License
RenewalLicense Validity5 years from the approval year5 years from the approval date1 year from approval
Renewal PeriodRenewal system opens Oct 1 – Dec 31Renew before the license expiresRenewal system opens Oct 1 – Dec 31
FeesEvaluation Fee–THB12,0003,000
Renewal Fee – THB (Local Production)2,00010,0005,0005001,000
Renewal Fee – THB (Import)4,00020,00010,0001,0001,000
Late FeesFine (THB per day)5001,0005001,0001,000
Late Renewal SubmissionMust apply within 1 month after expiration with a valid reason for late submission.
Expired LicenseThe 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:

TypePunishmentRequirement
 Fine up to 5,000 THBFine up to 10,000 THBBusiness terminationNo-renewal
1. Establishment license form Lor Por.1 with relevant documentsform Lor Por.2 with relevant documents
2. Sales license form Lor Por.1 with relevant documentsform Lor Por.2 with relevant documents
3. Certificate of Licensed/ Notified form Lor Por.1 with relevant documentsform 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 documentsform 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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