The Ministry of Public Health has released a draft Notification for public consultation proposing amendments to the fees collected in the medical device product authorization process. The draft was published on 11 December 2025 through official platforms of the Thai Food and Drug Administration and outlines proposed fee exemptions applicable to specific categories of applicants.
Read the full announcement to learn more:
- https://www.facebook.com/fdathaidevice
- https://law.go.th/listeningDetail?survey_id=NjI3M0RHQV9MQVdfRlJPTlRFTkQ=
Review the draft Notification for details on proposed fee exemptions.
Fees to be Collected from Applicants in the Medical Device Product Authorization Process. [PDF]
Purpose of the Draft Notification
- To propose amendments to the existing fee structure applicable to medical device product authorization procedures in Thailand.
- To introduce fee exemptions for specific applicant groups under defined circumstances.
- To support affected stakeholders through targeted regulatory fee relief measures.
Key Highlights
Proposed Fee Exemptions
If finalized, the Notification would introduce new fee exemptions effective from 01 December 2025 for the following applicant categories:
Royal Projects and Royal Initiative Projects
- Applicants involved in Royal Projects or projects arising from Royal Initiatives would be fully exempt from all fees related to the medical device product authorization process.
Disaster-Affected Operators
Applicants officially recognized as disaster victims under Thailand’s disaster prevention and mitigation laws would be eligible for fee exemptions limited to renewal-related procedures only, including:
- Renewal assessment and inspection for:
- Manufacturing establishment registration certificates
- Import establishment registration certificates
- Medical device sales licenses
- Verification of information for renewal of notifications for manufacture or import
The Thai FDA Secretary-General will officially designate:
- Affected disaster areas
- Types of disasters
- Applicable periods for fee exemption
Implications to Clients
- The proposed fee exemptions apply only to renewal procedures.
- New applications, amendments/changes, and license transfers are not covered under the proposed exemptions.
- The Notification is currently in draft form and not yet legally effective. Stakeholders should not rely on the exemptions until formal issuance.
Public Consultation Status
- Status: Draft for public consultation
- Effectivity date: To be announced upon final issuance
Stakeholders are encouraged to monitor developments and review the draft Notification to assess potential impacts on upcoming renewal activities.
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.
