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January 26, 2026
Approximately 5 minutes
Thailand Notification on Medical Devices Requiring Specification Declaration (2020)
Thailand Notification on Medical Devices Requiring Specification Declaration (2020)
1. Legal Basis and Issuance
The Notification of the Ministry of Public Health Re: Medical Device that Requires Specification Declaration was issued on 29 December 2020 under the authority of Section 7 and related provisions of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf It establishes mandatory specification declaration requirements for certain medical devices to support product registration, import, and distribution controls.
2. Purpose and Scope
The Notification aims to require manufacturers and importers to formally declare key technical specifications and performance characteristics of selected medical devices, enabling the Thai FDA to verify compliance with essential principles of safety, quality, and performance. It applies to devices classified as requiring this additional declaration step beyond basic licensing or notification. https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
3. Categories Requiring Specification Declaration
The Notification lists specific categories or types of medical devices that must submit a specification declaration, typically including:
- Devices with measuring functions
- Certain active therapeutic devices (e.g., infusion pumps, ventilators)
- In vitro diagnostic devices (especially those for self-testing or near-patient testing)
- Sterile or single-use devices where performance claims are critical
- Devices incorporating software or digital components affecting safety
- Specific diagnostic imaging or radiation-related equipment https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
These categories generally align with moderate- to higher-risk classes where detailed technical verification is deemed necessary.
4. Required Specification Content
The declaration must include detailed information such as:
- Technical specifications (dimensions, materials, electrical ratings, etc.)
- Performance characteristics and test methods
- Intended performance claims and limitations
- Sterilization/validation data (if applicable)
- Software/firmware version and validation summary
- Reference to applicable standards or test reports https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
The declaration must be accurate, supported by evidence, and submitted in the prescribed format.
5. Submission and Verification Process
- Specification declarations are submitted as part of the device registration or import license application.
- The Thai FDA reviews the declaration for completeness and consistency with claimed performance.
- Inconsistencies or unsubstantiated claims may result in rejection or additional testing requirements. https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
6. Compliance and Enforcement
Failure to provide a correct and complete specification declaration may lead to refusal of registration/import approval, product suspension, or penalties under the Medical Devices Act. Post-market surveillance may verify declared specifications against actual performance. https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
7. Alignment with Broader Framework
This Notification complements Thailand’s risk-based classification and licensing system by adding a layer of technical transparency for devices where performance specifications are critical to safety and efficacy assurance. https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
It supports consistent evaluation and helps prevent misleading claims in the Thai medical device market. https://en.fda.moph.go.th/media.php?id=482372025101459456&name=20201229%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Specification%20Declaration.pdf
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