A list of selected frequently asked questions regarding the renewal of the medical device approval certificates, translated from Thai FDA official website to provide overseas companies with a clear understanding of the content.

 

Medical Device Registration Renewal in Thailand: Essential FAQ for Overseas Companies

• Q: Which medical device registrations require renewal applications between October 1-December 31, 2025?

➝ A: Class 2-4 medical devices with licenses or notifications expiring on December 31, 2025 must submit renewal applications. This includes devices with 12-digit Thai FDA registration numbers beginning with "64-x-x-x-xxxxxxx".

• Q: When must renewal fees be paid for devices with registration numbers starting with "64-x-x-x-xxxxxxx"?

➝ A: Payment of renewal fees must accompany your application and be completed by December 31, 2025.

• Q: What are the medical device renewal fees in Thailand?

➝ A: There is no application fee. Renewal fees are: Licensed Medical Device (Class 4): 20,000 THB. Notified Medical Device (Class 2-3) - 10,000 THB.

• Q: Will approved Partial 1/Partial 2 CSDT status change to Full CSDT after renewal if no Serious Adverse Events occurred?

➝ A: No. Your CSDT classification remains as Partial 1 or Partial 2 after renewal.

• Q: Can change notification requests be submitted during pending renewal applications?

➝ A: Complete all change notification before submitting renewal applications. If change notification cannot be approved in time, prioritize renewal completion first, then submit modifications afterward.

• Q: Can renewal applications be submitted after the December 31, 2025 deadline?

➝ A: Yes, within one month of expiration (by January 30, 2026). Requirements include explanation letter for delay, standard renewal fee, and 1,000 THB daily penalty from expiration to submission date.

• Q: Can products be imported or sold if renewal is submitted late within the one-month grace period?

➝ A: After submitting your late renewal application and paying all fees including penalties, you may continue importing and selling until Thai FDA issues a non-approval decision.

• Q: What requirements apply if not renewing a medical device license or notification?

➝ A: No renewal application is required. However, the license holder submit a report to Thai FDA Secretary-General within 30 days using Form L.P. 2, including remaining product quantity and storage location. Non-compliance penalties up to 10,000 THB under Medical Device Act.

• Q: When must Abridged pathway registrations starting with "67-x-x-x-xxxxxxx" be renewed?

➝ A: Between October 1-December 31, 2028, as these registrations have five-year validity periods.

• Q: What documents are required for Abridged pathway registration renewals?

➝ A: No additional documents required. Approval is immediate upon fee payment.

• Q: Do HIV test kits require additional documentation for renewal?

➝ A: Yes. Submit an analysis report issued within the last 2 years.

• Q: Do non-HIV medical devices require analysis reports for renewal?

➝ A: No analysis reports needed for other products.

• Q: What if Serious Adverse Events occur after submitting renewal applications?

➝ A: Report through HPVC's Adverse Event Online Reporting system immediately. Notify Medical Device Control Division staff to redirect your renewal to the SAE processing channel.

• Q: What is the renewal process for devices with Serious Adverse Events (SAEs)?

➝ A: The Working Committee for Medical Device License/Notification Renewal reviews these cases and determines whether to approve or deny renewal.

• Q: For products with open FSCA but no serious safety impact and no SAEs, are additional documents required?

➝ A: No. Additional documentation (V&V, Risk Management files, Disposal management after use) is only required when the SAEs have occurred.

 

Need Support with Renewals?

Our regulatory specialists are committed to helping clients adapt to these regulatory shifts seamlessly. Whether you are preparing renewal dossiers, managing post-market obligations, or considering future submission strategies, our expertise ensures you stay ahead in a rapidly evolving environment.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you're a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential.

 

Reference

Frequently Asked Questions on Renewal of Medical Device License/Notification Certificates