What is medical equipment? Classes of medical devices in Vietnam

What is medical equipment? Classes of medical devices in Vietnam (Internet image)

Regarding this issue, LawNet responded as follows:

1. What is medical device?

According to Clause 1, Article 2 of Decree 98/2021/ND-CP, medical device means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

- It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:

+ Diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;

+ Investigation, replacement, modification or support of the anatomy or of a physiological process;

+ Supporting or sustaining life;

+ Control of conception,

+ Disinfection of medical devices;

+ Providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

- The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned in Point a of this Clause.

2. Classes of medical devices in Vietnam

Specifically, in Article 4 of Decree 98/2021/ND-CP, medical devices shall be classified into the following 4 classes according to their levels of potential risks related to their designs and manufacture:

- Class A: Low risk.

- Class B: Low-moderate risk.

- Class C: Moderate-high risk.

- Class D: High risk.

3. Classification rules for medical devices in Vietnam

Classification rules for medical devices in Vietnam specified in Article 5 of Decree 98/2021/ND-CP include:

- The classification of medical devices must be carried out in accordance with risk classification rules.

- 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.

- 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.

- 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.

- 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.

- 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.

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