The published announcement subject to License Renewal reforming core information can be found as below:

• Applicable Scope: Class 2, 3, and 4 medical devices.
• Renewal Window: Every year from 1 October to 31 December.
• Effective Date: 22 July 2025.

 

Key Changes in Renewal Process

Previously, renewal required submission of Full CSDT, regardless of original application pathway. Under the new system, requirements are divided into 2 main categories:

1. Renewal of Full CSDT Registrations

If the initial application was submitted with a Full CSDT dossier, renewal would be seamless.

• ✔  No new documents are required.
• ✔  Upon payment of the renewal fee, the certificate will be automatically extended for 5 years.

Exception: HIV test kits still require submission of the additional test report.

2. Renewal of Partial 1 or Partial 2 Registrations

Devices registered under Partial 1 or Partial 2 pathways are divided into 2 groups based on post-market criteria within the past 5 years:

(1) serious adverse events,

(2) device deficiencies that could lead to serious adverse events,

(3) suspicion regarding the quality, efficacy, or safety of the medical device.

 

Group 1: No Serious Issues

None of the three criteria above occurred. The "Safety Declaration Form for Renewal of Medical Devices Registered under Partial 1 or Partial 2 Pathway" is required for submission.

 

Group 2: Safety Concerns Identified

At least one of the three criteria above occurred. The "Safety Declaration Form for Renewal of Medical Devices Registered under Partial 1 or Partial 2 Pathway" is required, along with additional documentation.

 

Document Requirements for Renewal

No.	Document Description	Case 1: No SAE			Case 2: With SAE
		Full-CSDT	Partial 1	Partial 2	Full-CSDT	Partial 1	Partial 2
1	Executive summary	-	✔	-	-	✔	-
2	Essential Principal Checklist	-	✔	✔	-	✔	✔
3	Summary of verification & validation	-	-	-	-	✔	✔
4	Risk analysis	-	-	-	-	✔	✔
5	Ways of deterioration after use	-	-	-	-	✔	✔
6	QMS certificate	-	✔	-	-	✔	-
7	Declaration letter on quality/ packaging/ labeling/ instruction for use	-	✔	✔	-	✔	✔
8	Marketing history declaration	-	✔	✔	-	✔	✔
9	Safety declaration	-	✔	✔	-	✔	✔
10	Approval evidence from reference agencies	-	✔	✔	-	✔	✔
Total		0	7	5	0	10	8

 

Special Note on Abridged CSDT Dossiers

The Thai FDA has also included Abridged CSDT dossiers (applications referencing foreign regulatory approvals) in its announcement, allowing for certain exemptions in the renewal process.

However, detailed requirements for renewal under this pathway have not yet been provided. Since certificates issued under the Abridged route will not expire until 31 December 2028, there is no immediate need for stakeholders to submit renewal documents, but they should stay informed for future updates.

 

Implications for Industry Stakeholders

• The updated Thai FDA renewal framework has several key implications for manufacturers and importers:
  • 1. Strategic Advantage for Full CSDT Dossiers:
  • - Devices registered with a full CSDT dossier benefit from automatic five-year certificate renewal.
  • - This reduces administrative workload and minimizes the risk of delays.
  • 2. Document Preparation for Partial Pathways:
  • - For devices registered under Partial 1 or Partial 2 pathways, companies must track post-market criteria including adverse events, device deficiencies, and quality concerns.
  • 3. Post-Market Vigilance:
  • - Maintaining accurate and timely records of safety and efficacy is essential to meet renewal requirements.
  • - Proactive monitoring can prevent unexpected delays during the assessment of Partial pathway renewals.

By understanding these implications, industry stakeholders can better align their internal processes and regulatory strategy to ensure compliance and operational efficiency.

Remark: Organizations may consider preparing and submitting required documents throughout the year to streamline the renewal process.

 

Conclusion

Thai FDA's 2025 renewal framework reflects a modernized, risk-based approach that benefits both regulators and industry stakeholders. By easing requirements for compliant devices while maintaining safeguards for safety, the system enables more strategic business planning. For organizations with devices registered under Partial pathways, early preparation is essential to ensure smooth renewals.

The announcement represents a constructive development. The automatic renewal mechanism demonstrates the maturity of the regulatory system and eagerness of the industry.

As Thai FDA continues to refine requirements, particularly for Abridged dossiers, staying informed will be crucial for ongoing compliance and operational efficiency.

 

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!

 

References

1. Exemption of Information, Documents, or Evidence from Submission for the Renewal of Class 2–4 Medical Device Approval Certificates, B.E. 2568 (2025)
2. Thai FDA: Renewal Process For Notified and Licensed Medical Devices