In an effort to ease the renewal process for medical device licenses and notifications, the Thai FDA has introduced exemptions for certain documents and information, which took effect on the 22nd of July 2025.
This change applies to licensees or notifiers who face difficulties in renewing their licenses or notifications. The decision comes under Section 32 of the Organization of State Administration Act, B.E. 2534 (1991), as amended by the Act (No. 5), B.E. 2545 (2002).
Read the official announcement here: Exemption of Specific Information, Documents, or Evidence from the Renewal of License or Notification for Manufacturing/Importation of Medical Devices
Key Details:
- Clause 1: This announcement takes effect from the day after its publication in the Government Gazette.
- Clause 2: In cases where certain documents or evidence are exempted, especially for documents assessed through reference countries and foreign regulatory authorizations, the FDA Secretary-General may allow applicants to skip some document requirements during license or certificate renewals to streamline the process.
- Clause 3: The exemptions apply to licensees or notifiers who are unable to submit specific documents due to pending design verification, risk analysis, or safety evaluations.
However, the following conditions must be met:
- The medical device has not been linked to any serious adverse events.
- The device is free of functional issues that could result in serious adverse events.
- There is no reasonable suspicion regarding the device’s safety, efficacy, or quality.
- Clause 4: The exempted documents include the following:
- Design verification and validation summaries (Section 2(5) of Ministerial Regulations B.E. 2563, 2020)
- Risk analysis documentation (Section 2(6) of Ministerial Regulations B.E. 2563, 2020)
- Waste disposal or destruction method (Section 2(7) of Ministerial Regulations B.E. 2563, 2020)
Implications for Stakeholders
Importers and local manufacturers with product certificates under the full CSDT, abridged pathway, or partial pathway may be eligible for exemptions from submitting certain technical documents during the renewal process.
Devices must meet the outlined safety and performance criteria, thereby reducing the regulatory burden for these entities.
Effective Date: July 22, 2025
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