Thailand Notification on Medical Devices Requiring Notification (2020)

1. Legal Basis and Effective Date

This Notification was issued by the Ministry of Public Health on 16 July 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=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf It came into effect upon publication in the Government Gazette, replacing or supplementing prior notifications on the same subject.

2. Purpose

The Notification aims to identify low-risk medical devices that do not require full product licensing but must be notified to the Thai Food and Drug Administration (Thai FDA) before being placed on the market. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf This risk-based approach facilitates faster market entry for non-critical devices while ensuring regulatory visibility and post-market control.

3. Scope and Device Categories

The Notification lists specific categories and examples of medical devices subject to the notification requirement rather than full registration/licensing. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf These typically include Class I and some Class IIa devices (per Thailand’s classification rules aligned with international standards), such as:

• Non-sterile or low-risk instruments (e.g., manual surgical instruments, bandages, certain diagnostic tools)
• Certain in vitro diagnostic (IVD) reagents of low individual and public health risk
• Reusable devices with low contamination risk
• Specific consumables and accessories without direct therapeutic effect

4. Notification Procedure

Importers, manufacturers, or distributors must submit a notification to the Thai FDA prior to marketing. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf Required information generally includes:

• Device description and intended use
• Manufacturer and importer details
• Classification rationale
• Declaration of conformity to essential principles
• Labeling and instructions for use samples

Upon acceptance, the Thai FDA issues a notification receipt, allowing market placement.

5. Exclusions and Higher-Risk Devices

Devices not listed in this Notification require full licensing under separate regulations. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf Higher-risk categories (e.g., Class IIb, Class III, sterile devices, active implants) remain subject to complete product registration and conformity assessment.

6. Compliance and Enforcement

Failure to notify listed devices before marketing constitutes a violation of the Medical Devices Act, potentially leading to administrative sanctions, product seizure, or criminal penalties. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf The Thai FDA maintains post-market surveillance for notified devices, including adverse event monitoring and random sampling.

7. Significance

This Notification reflects Thailand’s risk-based regulatory framework, balancing patient safety with efficient market access for low-risk medical devices. https://en.fda.moph.go.th/media.php?id=482373295589695488&name=20200716%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Medical%20Device%20that%20Requires%20Notification.pdf It aligns with ASEAN harmonization efforts and international best practices while supporting domestic healthcare needs.