What are regulations on classification rules for medical devices in Vietnam?
Please ask, when classifying medical devices, what rules must be followed? Looking forward to support under the new regulations.
According to Article 5 of Decree 98/2021/ND-CP (Effective from 01/01/2022), classification rules for medical devices in Vietnam are as follows:
1. The classification of medical devices must be carried out in accordance with risk classification rules.
2. In the event that a medical device only has one intended purpose which is assigned into two or more risk levels, that medical device shall be assigned into the class representing the highest risk level.
3. In the event that a medical device has multiple intended purposes and each of which represents various risk levels, that medical device shall be assigned into the class representing the highest risk level.
4. In the event that a medical device is designed to be used in combination with another medical device, each of the medical devices shall be classified separately.
IVD medical devices that are equipment or systems used in testing process and reagents, titrants, calibrators or control materials may be assigned into various risk levels but assigned into the class representing the highest level of risks posed by the final purpose of that medical device as a whole. IVD medical devices that are other products used in or supporting testing process may be separately assigned into risk levels.
5. The Minister of Health shall provide detailed guidelines on classification of medical devices in accordance with ASEAN’s treaties on classification of medical devices to which Vietnam is a signatory.
6. The classification of medical devices must be carried out by the classification body whose name is specified in the declaration of applied standards or certificate of registration of medical device.
Best Regards!
