Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 25, 2026
Approximately 5 minutes
Thailand's Medical Devices Act B.E. 2551 (2008)
Thailand's Medical Devices Act B.E. 2551 (2008)
1. Purpose and Scope
The Medical Devices Act B.E. 2551 (2008) aims to regulate the production, importation, exportation, distribution, and advertising of medical devices to ensure their safety, quality, and efficacy for public health protection. https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf The Act applies to all medical devices as defined in Section 4, including instruments, apparatus, machines, implants, in vitro diagnostic reagents, and software intended for medical purposes.
2. Key Definitions
Section 4 provides essential definitions:
- Medical device — Any instrument, apparatus, machine, implant, in vitro reagent, calibrator, software, material, or other article intended by the manufacturer for human use for diagnosis, prevention, monitoring, treatment, alleviation of disease/injury, investigation/replacement/modification of anatomy, supporting/maintaining life, contraception, disinfection of devices, or control of conception.
- Licensed medical device — A device for which a license has been granted.
- Notified medical device — A device notified to the authority without requiring full registration. https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
3. Licensing and Registration Requirements
Sections 6–21 establish the core regulatory controls:
- No person shall produce, import, or distribute medical devices without a license from the Thai FDA (Section 6).
- Certain low-risk devices may only require notification instead of full registration.
- Licenses are issued for manufacturing premises, importation, and distribution, with validity periods and renewal requirements.
- The Minister may classify devices into categories and specify which require licenses or notifications (Section 7). https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
4. Standards and Essential Principles
The Act empowers the issuance of ministerial regulations and notifications to prescribe:
- Quality system requirements (e.g., GMP)
- Essential principles of safety and performance
- Labeling and instructions for use
- Clinical evaluation and post-market surveillance obligations https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
5. Advertising and Promotion Controls
Sections 88–92 prohibit false, exaggerated, or misleading advertising of medical devices and require pre-approval of certain promotional materials. https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
6. Post-Market Surveillance and Enforcement
The Act includes provisions for:
- Adverse event reporting
- Recall and field safety corrective actions
- Inspection powers
- Penalties for violations, including fines and imprisonment https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
7. Implementation and Supporting Regulations
The Act is supported by numerous ministerial regulations, notifications, and guidelines issued by the Thai FDA, which detail classification rules, registration dossiers, conformity assessment, and specific requirements for different device types. https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
This foundational legislation has shaped Thailand’s medical device regulatory system, aligning with international standards while addressing local public health needs. https://en.fda.moph.go.th/media.php?id=516856465517060096&name=Medical%20Devices%20Act,%20B.E.2551%20(2008).pdf
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Requirements for Medical Device Import Facilities in Thailand
The 2009 Notification of the Ministry of Public Health specifies standards and requirements for medical device import facilities in Thailand, including premises layout, equipment, personnel qualifications, quality management systems, storage conditions, and documentation to ensure imported devices maintain safety, quality, and efficacy.
Approximately 5 minutes
Thailand Notification on Licensed Medical Devices (2020)
The 27 April 2020 Notification of the Ministry of Public Health lists categories of medical devices that require a license for production, importation, or distribution in Thailand, classifying them based on risk and intended use to ensure appropriate regulatory control under the Medical Devices Act B.E. 2551 (2008).
Approximately 5 minutes
Thailand Notification on Medical Devices Requiring Notification (2020)
The Notification of the Ministry of Public Health dated 16 July 2020 specifies the list of medical devices that require notification (rather than full licensing) prior to importation, manufacturing, or distribution in Thailand, categorizing low-risk devices to streamline market access while maintaining safety oversight by the Thai FDA.
Approximately 5 minutes
Thailand Notification on Medical Device Malfunctions and Adverse Events (2020)
The 22 October 2020 Notification of the Ministry of Public Health mandates reporting of medical device malfunctions, adverse events, and field safety corrective actions in Thailand, defining timelines, responsible parties, report contents, and procedures to enable timely risk management and protection of public health under the Medical Devices Act.