The Thai FDA has published an infographic and FAQs detailing the renewal process for five types of medical device licenses. The guidance provides step-by-step procedures, timelines, fees, and frequently asked questions to support registrants in maintaining compliance.
To view the official announcement:
Infographic- กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
FAQs: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
Scope
The announcement covers renewal procedures for establishment and sales licenses, including certificates of licensed, notified, and listed devices. It highlights the renewal system’s timelines, required documents, fees, and consequences of late submission or non-renewal.
Renewal Process – Steps
- Download forms from the Medical Device Control Division’s website.
- Register for an OPEN ID username and password.
- Request access to the SKYNET FDA system.
- Submit the application, verify details on the website, and complete payment by December 31 of the year the license expires.
- Receive the renewed license through the SKYNET FDA system.
Details
Type | Purpose | Thai FDA Licenses | ||||
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 (Import / Local production) | – | – | – | 3,000 |
Renewal Approval Fee – THB (Local Production) | 2,000 | 10,000 | 5,000 | 500 | 1,000 | |
Renewal Approval Fee – THB (Import) | 4,000 | 20,000 | 10,000 | 1,000 | 1,000 | |
Late Fees | Fine (THB per day) | 500 | 1,000 | 1,000 | 500 | 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 | |||||
FAQ: Renewal Medical Device Certificate of Licensed/Certificate of Notified and Certificate of Listed
Q1: What are the licenses of medical device required to submit to system of license/notification for renewal?
A1: For medical devices with a Class 2 – 4 risk classification that received a license/notification (Expiry date 31st December 2025) or the registration number will start with “64-x-x-x-xxxxxx”.
Q2: For a medical device with a Class 2-4 risk classification that has a registration number starting with “64-x-x-x-xxxxxx”, when is the deadline to make payment for renewal?
A2: Payment can be made until December 31, 2025.
Q3: Are there any fees for the renewal of a license/notification or detail registration for a medical device?
A3: Yes, there are fees for the renewal of a license/notification or detail registration as follows:
- Production License of Medical device: 10,000 baht
- Import License of Medical device: 20,000 baht
- Production Notification of Medical device: 5,000 baht
- Import Notification of Medical device: 10,000 baht
Q4: In cases of license/notification that were approved as Partial 1/Partial 2. Once the renewal application is submitted without Serious AE, will the license and Notification be approved with upgrading to be Full CSDT?
A4: The approval process will keep the Partial 1 or Partial 2 the same.
Q5: If a company submits a renewal application and it also has a pending change notification during that time, can the Thai FDA consider the renewal application? If not, which application should be submitted first?
A5: Thai FDA requires approval of the change notification first before submitting the renewal. In case the change notification is under review/not approved before submitting the renewal, the registrant should submit the renewal first and wait for approval. After that, the change notification can be submitted later.
Q6: Can license/notification be submitted for the renewal application after 31 December 2025?
A6: A renewal application can be submitted after expiration for one month in the channel of the renewal application, requiring also the extension letter, and the declaration letter for the reason of the delay in the renewal. There is a fine of 1,000 baht per day after the expiry date until the submission date of renewal.
Q7: If a registrant submits a renewal application but is 1 month late (January 1, 2026 – January 30, 2026), can they still import/sell the product?
A7: When the registrant submits a renewal application and has paid the fine, import/sell can proceed until the Thai FDA does not allow import/sell.
Q8: If the registrant does not intend to renew the license/notification, what should they do?
A8: In case the license/notification holder has expressed his intention not to renew. It requires submitting the remaining medical devices in the storage place to Thai FDA within 30 days from the expiry date of the license/notification. This termination shall be informed in Lor.Por.2 (ล.พ.2). Failure to comply shall be subject to penalties under Section 96 of the Medical Device Act B.E. 2551 (2008) and its Amendment B.E. 2562 (2019), with a fine not exceeding 10,000 Baht.
In the case of business closure, the remaining medical devices and storage place in Lor.Por.1 (ล.พ.1). and the remaining medical devices and storage place in Lor.Por.2 (ล.พ.2) in case not intended to renew or the authority does not allow to renew, it requires submission via SKYNET.
Q9: For medical devices that have been approved as Abridged and have a registration number starting with “67-x-x-x-xxxxxx”, when should the renewal application be submitted?
A9: This is because the Abridged approval is only valid for 5 years and expires between October 1, 2028, and December 31, 2028.
Q10: If a medical device was previously approved as an Abridged registration, how can I submit a renewal application?
A10: You do not need to submit additional documents. Once submit a renewal application and pay the fee, the license/notification will be approved automatically.
Q11: Are there templates for these documents? The documents according to items 7-9 below.
- A declaration letter to certify the purpose of use, packaging, label, and procedure from the manufacturer/owner
- A declaration letter for marketing history from the manufacturer/owner
- Evidence of approval from other countries that the Thai FDA certifies
- Safety declaration letter from the manufacturer/owner
A11: There are links for downloading on website of Medical Device Division Control > Product > Renewal > Forms
Q12: How should I submit the documents for items 7, 8, and 9?
A12: You must submit the documents as one file.
Q13: Are there any additional documents for the HIV test kit?
A13: The evaluation results of the HIV test kit are mandatory to submit.
Q14: Apart from the HIV test kit, are there any other products that require submitting an evaluation test?
A14: None.
Q15: If a medical device was approved as Partial 1 or Partial 2 between 2021 and 2025, and there have been Serious AE, what should be done?
A15: The registrant can find further information supporting documents on the website of the Medical Device Division Control > Product > Renewal.
Q16: What happened with the renewal of a license/notification with Serious AE during renewal?
A16: The registrant shall submit the AE case to AE online reporting from the HPVC website and then inform Thai FDA to switch the route of submission for SAE.
Q17: How does the Thai FDA consider the renewal application with Serious AE?
A17: There are experts on the committee to consider.
- The committee accepts it, the renewal application will be approved.
- The committee does not accept it; the renewal application will not be approved.
Q18: In case there is FSCA but there is no Serious AE, is it mandatory to submit a renewal application with V&V, Risk Management file, and Disposal? (The announcement does not mention clearly, but in the Safety Declaration Form for Renewal of Medical Devices Registered under Partial 1 or Partial 2, it shows a checklist of FSCA.)
A18: It is not mandatory to submit V&V, Risk Management file, and Disposal. Only Serious AE requires additional documents of V&V, Risk Management file, and Disposal.
Q19: In case of FSCA in Thailand has closed, but some countries are still pending. For this case, Thai FDA will consider it a closed case or a pending case, and also consider exempting the additional document or not. Are there any additional documents that Thai FDA requires to declare?
A19: SAE is under consideration by the owner, including consideration of closing the case. It requires a close-by owner.
Q20: Are the adding documents system and renewal system similar? Can the registrant submit both systems at the same time?
A20: Adding the documents system is a voluntary process for registrants who submit via Partial 1, Partial 2 and Abridged pathway. The channel will open from February to September each year.
Renewal system is mandatory for a license/notification that will have an expiry date in that year. The system will open from 1 October to 31 December each year.
Q21: In case of the registrant has submitted via Partial 1, Partial 2, and has the intention not to add documents to be Full CSDT, can they submit a renewal application for a license/notification?
A21: Adding the documents system is voluntary process; it means that the registrant can submit a renewal application for a license/notification.
Q22: How can the registrant add the documents from Partial 1 and Partial 2, to be Full CSDT?
A22: Learn more on the website of Medical Device Control Division>Product>adding documents system.
Q23: In case of adding documents from Partial 1 and Partial 2, to be Full CSDT complete, how to submit the next step for renewal application?
A23: The registrant can submit a renewal application and pay the application fee. The system will renew automatically.
Q24: Once the registrant uploads the documents to the adding documents system, then Thai FDA reviews, but has not finished by the end of September 2025. Can the registrant submit a renewal application continuously? Can Thai FDA continue to consider the pending documents in adding document system?
A24: Adding the documents system is voluntary process. In case there are a lot of applications, the Thai FDA might not review in time, then the registrant is advised to add documents at least 1 month before the system will be closed. In case the applications are pending in the documents system, the application will be rejected on 30 September 2025 at 24.00 and no further review.
Q25: In case the notification is paper format with registration number Jor.Nor./Jor.Por. XX/XXXX and the license is paper format with registration number Nor./Por. XX/XXXX, will the renewal system still be automatically approved as the same 2024?
A25: It is still Auto Approved as the same 2024 as follows
1st step: CSDT import system
It is an auto-approved system, not reviewed by Thai FDA officers. Once the registrant has submitted the documents completely, the next step is to submit the documents to the renewal system. The system will approve them automatically, except for 2 products such as Ophthalmic Viscosurgical Device and HIV Test kit, which require additional documents.
Learn more on the website of Medical Device Control Division>Product>Renewal (Paper format) which also requires review by Thai FDA officers.
2nd step: Renewal in paper format
The registrant shall access the renewal system and check the documents completely, then press the button to confirm the submission. The system will approve it automatically with a status of waiting for payment. Once the registrants make payment completely, the license/notification can be printed out from the system.
Effective Date
This announcement will come into force 30 days after publication in the Government Gazette.
Implications to Clients
- Companies holding establishment or sales licenses in Thailand must comply with the renewal timelines and fee requirements.
- Failure to renew on time may result in daily fines, penalties, or invalidation of licenses.
- Stakeholders should prepare early, especially when handling devices with Partial or Abridged approvals, to avoid processing delays.
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