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January 25, 2026
Approximately 5 minutes
Thailand Notification on Licensed Medical Devices (2020)
Thailand Notification on Licensed Medical Devices (2020)
1. Legal Basis and Issuance
The Notification of the Ministry of Public Health Re: Medical Device that Requires License was issued on 27 April 2020 under the authority of Section 7 of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf It replaces or supplements earlier notifications and specifies which medical devices must obtain a license before being produced, imported, or distributed in Thailand.
2. Purpose and Scope
The Notification aims to define categories of medical devices subject to mandatory licensing to ensure their safety, quality, and efficacy. It applies to manufacturers, importers, and distributors of the listed devices and covers both domestic production and importation. https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf
3. Categories Requiring License
The Notification classifies medical devices into groups that require licensing, including but not limited to:
- Active implantable devices (e.g., pacemakers, defibrillators)
- Invasive devices intended for long-term use or surgical intervention
- Devices incorporating medicinal substances or biological materials
- Sterile devices and those with measuring functions
- In vitro diagnostic devices for high-risk applications (e.g., HIV, hepatitis, blood grouping)
- Certain diagnostic imaging equipment and radiation-emitting devices
- Custom-made devices and those for specific high-risk clinical uses https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf
These categories generally correspond to higher-risk classes (e.g., Class IIb and III in risk-based systems).
4. Licensing Implications
Devices listed in the Notification cannot be legally produced, imported, or sold without a valid license from the Thai FDA. https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf License applications require submission of technical documentation, quality system evidence (e.g., ISO 13485), and conformity assessment data demonstrating compliance with essential principles.
5. Exemptions and Lower-Risk Devices
The Notification implies that devices not included in the listed categories may be subject only to notification or other lighter requirements, consistent with Thailand’s risk-based approach. https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf Detailed lists of exempted or notified-only devices are provided in separate notifications.
6. Enforcement and Compliance
Non-compliance with licensing requirements may result in penalties under the Medical Devices Act, including fines, product seizure, or prohibition of supply. The Thai FDA conducts market surveillance and inspections to verify compliance. https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf
This Notification forms a key part of Thailand’s tiered regulatory framework, focusing stricter controls on higher-risk medical devices to protect public health. https://en.fda.moph.go.th/media.php?id=482374034391179264&name=20200427%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Lincense.pdf
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