Thailand Risk Classification of Medical Devices (2020 Notification)

1. Legal Basis and Issuance

The Notification of the Ministry of Public Health Re: Risk Classification of Medical Devices was issued on 14 November 2020 pursuant to Section 7 of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf It provides the official risk classification rules to determine the level of regulatory oversight required for each medical device placed on the Thai market.

2. Purpose and Scope

The Notification aims to implement a risk-based regulatory approach by classifying medical devices according to the potential risk they pose to patients, users, or others, thereby determining the appropriate conformity assessment procedures, documentation requirements, and post-market obligations. It applies to all medical devices as defined in the Act, excluding certain exempted categories. https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

3. Four Risk Classes

Medical devices are classified into four classes based on increasing risk:

• Class 1 — Low individual risk and low public health risk (e.g., non-invasive devices without measuring function, simple bandages, manual surgical instruments).
• Class 2 — Low to moderate individual risk and/or low to moderate public health risk (e.g., most non-invasive measuring devices, certain invasive short-term devices).
• Class 3 — Moderate to high individual risk and/or moderate public health risk (e.g., invasive devices for long-term use, active therapeutic devices, certain in vitro diagnostics).
• Class 4 — High individual risk and/or high public health risk (e.g., active implantable devices, certain life-supporting devices, high-risk in vitro diagnostics such as those for transmissible agents). https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

4. Classification Rules

The Notification includes detailed rules for classification, aligned with international standards (e.g., IMDRF/GHTF principles), considering factors such as:

• Degree of invasiveness
• Duration of contact with the body
• Active or non-active nature
• Incorporation of medicinal substances or biological materials
• Intended purpose and intended user
• Delivery method (e.g., energy-emitting devices) https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

Specific rules apply to in vitro diagnostic devices, software, and combination products.

5. Implications for Regulation

Higher classes require more stringent conformity assessment:

• Class 1 — Often self-declaration or notification with minimal review.
• Class 2 — Requires quality management system certification and technical documentation review.
• Class 3 and 4 — Full conformity assessment, including type examination, design dossier review, and potentially clinical evaluation data. https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

6. Transitional and Special Provisions

The Notification provides for transitional arrangements for devices already on the market and special considerations for custom-made devices, investigational devices, and systems/procedure packs. https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

7. Compliance and Updates

Manufacturers and importers must classify their devices correctly and comply with the corresponding regulatory requirements. The Thai FDA may update the classification rules or issue additional guidance as needed. Incorrect classification may lead to enforcement actions under the Act. https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf

This Notification forms the cornerstone of Thailand’s risk-proportionate approach to medical device regulation, aligning with global best practices while addressing local public health priorities. https://en.fda.moph.go.th/media.php?id=482372261249163264&name=20201114%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Risk%20Classification%20of%20Medical%20Devices.pdf