Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand
The Thailand Food and Drug Administration (TFDA) made an announcement to notify importers and manufacturers in Thailand that the renewal system will be opened starting October 1st, 2023, to December 31st, 2023, for the following certificates:
- Establishment Registration Certificate
- Sales License
- License/ Notification Certificate (applicable for approved products based on the New Regulation)
- Listing Certificate (applicable for approved products based on the New Regulation).
For Establishment Registration Certificate, Sales License, License, and Notification Certificate:
Registrant shall submit their applications through the SKYNET FDA system. In the case where registrant submits their application between January 1st to 30th, 2024 after the certificate expires, a late renewal fee of 1,000 Baht (approx $28 USD) per day will be applied. For the Establishment Registration Certificate, the late renewal fee will be 500 Baht (approx $14 USD) per day. The registrant must also provide a reason for the late renewal, in the case of applying after December 31st 2023.
For Listing Certificate:
Registrant shall submit for a renewal application before the certificate expires. In the case of a late submission, the registrant will be subjected to a late renewal fee of 500 Baht (approx $14 USD) per day. The registrant must also provide a reason for the late renewal.
- Registrant shall download the template documents from the Medical Device Control Division (TFDA) website.
- Apply for an Open ID (Username & Password).
- Apply for access to SKYNET FDA.
- Registrant shall submit the renewal application and check the information on the website.
- Payment shall be done by December 31st of the year in which the license expires.
- Renewal Certificate will be received through the SKYNET FDA system.
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