6 February, 2020
To align the regulation of medical devices in Thailand with the ASEAN Medical Device Directive (AMDD), the Ministry of Public Health has issued a new notification to categorize medical devices based on the level of risk that may cause harm or impact on public health.
According to the Notification, effective from 19 December 2019 onwards, medical devices are categorized into:
(1) in vitro diagnostic medical device; and
(2) non-in vitro diagnostic medical device.
In vitro diagnostic medical devices are classified by the level of risk to individual and public health from lowest to highest as follows:
| Class | Risk Level |
| 1. | Low risk to individual and public health |
| 2. | Moderate risk to individual or low risk to public health |
| 3. | High risk to individual or moderate risk to public health |
| 4. | High risk to individual and public health |
Non-in vitro diagnostic medical devices are classified by the level of risk that may arise from lowest to highest as follows:
| Class | Risk Level |
| 1. | Low |
| 2. | Low to Moderate |
| 3. | Moderate to High |
| 4. | High |
Medical devices that fall into Class 4 of both the in vitro diagnostic medical device and non-in vitro diagnostic medical device categories require registration with the FDA.
Medical devices that fall into Class 2 and Class 3 of both the in vitro diagnostic medical device and non-in vitro diagnostic medical device categories require detailed notification; while those in Class 1 of both the in vitro diagnostic medical device and non-in vitro diagnostic medical device categories require notification only.
Manufacturers or importers of medical devices should familiarize themselves with the new risk classification. The FDA should soon issue further clarification on the criteria for risk assessment of medical device reclassification.
For further information, please contact:
