Medical Device Classification in Vietnam

Medical devices are classified in Vietnam according to the intended use, level of risk, delivery method, and the degree of invasiveness in the human body. Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Classification guidance can be found in Circular 39/2016.

Previously, medical device risk classification in Vietnam had to be determined by a locally certified organization or person but under the new regulations, the Registration Holder can classify the product as part of the application.

Devices are classified into one of the following, from lowest to highest risk:

• Class A
• Class B
• Class C
• Class D

IVD CLASSIFICATION RULES

IVDs in Vietnam are classified into 4 categories (A through D) according to 7 rules based on risk and closely follow ASEAN MDD guidance. Specific rules for classifying IVDs can be found in Part III of Appendix I, Circular 39/2016.

Factors affecting the risk include:

• Purpose of use and indications
• Expertise of the medical device user
• Importance and Impact of the Medical Device Information on Individuals and Public Health.