What is Medical Device? What does Medical Device Include?

What is a Medical Device?

(In accordance with Article 2, Decree No. 98/2021/ND-CP issued on November 8, 2021: On the management of medical devices)

Medical device includes various types of devices, implantable materials, instruments, materials, diagnostic reagents, and in vitro standard substances, as well as software that simultaneously meets the following requirements:

a) Used individually or in combination as directed by the owner of the Medical Devices to serve humans for one or more of the following purposes:

– Diagnosis, prevention, monitoring, treatment, and alleviation of diseases or compensation for injuries and trauma.

– Examination, replacement, adjustment, or support for anatomy and physiological processes.

– Support or maintain life.

– Birth control.

– Disinfection of medical devices.

– Provide information for diagnosis, monitoring, and treatment through testing samples originating from the human body.

What Does Medical Device Include?

(In accordance with Article 4, Decree No. 98/2021/ND-CP issued on November 8, 2021: On the management of medical device)

Types of Medical Devices:

Medical device is classified into four types based on the inherent risk associated with the technical design and production of the respective medical devices:

• Class A: Low risk, for example  nasal inhalation tubes.
• Class B: Medium-low risk, for example fluid transmission tubes.
• Class C: Medium-high risk, for example ventilators.
• Class D: High risk, for example  artificial heart valves.

Principles of Medical Device Classification:

• Based on the principle of risk levels.
• If a medical device has only one intended use but that The purpose of use can be classified into two or more different risk levels, then the classification is based on the highest risk level.
• If a medical device has multiple intended uses, and each intended use has a different risk level, the classification is based on the highest risk level.
• In the case where a medical device is designed for use in combination with another medical device, each medical device must be classified separately based on its risk level.

(For in vitro diagnostic medical devices, components such as devices, device systems participating in the testing process, diagnostic drugs, control substances, standard substances, and controlled materials are classified separately. However, the final classification is based on the highest risk level of the ultimate purpose of the combined overall medical device. In vitro diagnostic medical devices are other products involved or supporting the testing process and are classified separately.)

The classification of medical devices must be carried out by the entity responsible for publishing standards or registering for circulation

To receive advice on document services, procedural processes, and registration of medical device, customers can contact the Hotline at: 098.546.1894