Vietnam’s Circular No. 30/2015/TT-BYT: What is medical equipment?

According to Circular No. 30/2015/TT-BYT of the Ministry of Health of Vietnam, medical equipment is the types of equipment, tool, material and in-vitro diagnosis chemical and software used separately or combined with each other as indicated by the owner to serve people for one or a lot of purposes as follows:

- Diagnosis, prevention, monitoring, treatment and mitigation of disease or injury compensation;

- Checking, replacement, modification or surgery support and physiological process;

- Life support or sustainment;

- Conception control;

- Sterilization of medical equipment (not including chemicals and insecticides and disinfectants for domestic and medical use);

- Use for medical equipment;

- Special transport for medical activities.

Concurrently, the import of medical equipment in the form of foreign aid (including medical equipment of over 80% quality), temporary import and re-export, temporary export and re-import, border transfer of goods, medical equipment as movable property, in service of personal needs with diplomatic status and personal luggage shall comply with the provisions of Decree No. 187/2013/ND-CP dated 20/11/2013 of Vietnam’s Government detailing the implementation of the Commercial Law on trading of international goods and activities of trading and processing agents and goods transit with foreign countries and the guidelines of the Ministry of Industry and Trade.

Besides, Circular No. 30/2015/TT-BYT also stipulates that medical equipment owner (hereafter referred to as owner) is any organization or individual directly implementing or permitting other organizations or individuals to use his/her name to provide the medical equipment in his/her own name or any label, design, commercial name or other names or other codes under the ownership or control of such organizations or individuals and shall take responsibility for the design, production, assembly, label, packaging, or maintenance, repair of medical equipment or define a purpose of use for such medical equipment.

View more details at Circular No. 30/2015/TT-BYT of the Ministry of Health of Vietnam, effective from November 30, 2015.

Le Hai

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