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6 medical devices subject to safe and technical inspection
The Circular No. 05/2022/TT-BYT detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices is issued on August 01, 2022 by the Ministry of Health.
Accordingly, 6 medical devices subject to safe and technical inspection include: Ventilator; Anaesthesia ventilator; Electric scalpel; Infant incubator; Defibrillator; Dialysis machine.
Besides, a number of medical devices of types B, C, and D that can be traded as other normal goods includes: Personal blood pressure monitor; Baby nasal aspirator; Electronic thermometer, infrared thermometer; Nebulizer; Medical bandage and gauze; Condom; Contraceptive film (not containing drugs); Self-testing in vitro diagnostic medical devices for HIV, SARS-CoV-2, etc.
The Circular also provides the list of medical devices being granted import licenses as prescribed at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP, including X-ray imaging devices; magnetic resonance imaging; diagnostic ultrasound machine; diagnostic endoscopy system; cyclotron system; immunoassay machine; cell extractor, etc.
This Circular takes effect on August 1, 2022.
For further details of the Circular 05/2022/TT-BYT, Click here
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
Detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices
Pursuant to the Government’s Decree No 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices;
At the request of the Director of the Department of Medical Equipment and Construction;
The Minister of Health promulgates the Circular detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.
1. This Circular details a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices (hereinafter referred to as Decree No. 98/2021/ND-CP), including:
a) Classification of medical devices prescribed in Clause 5, Article 5 of Decree No. 98/2021/ND-CP;
b) The supplement of the list of in vitro diagnostic medical devices that is not subject to quality assessment by any competent agencies of Vietnam prescribed at Point dd, Clause 3, Article 30 of Decree No. 98/2021/ND-CP;
c) The list of medical devices of types B, C, D that can be traded like other normal goods prescribed in Clause 1, Article 42 of Decree No. 98/2021/ND-CP;
d) The list of medical devices subject to safe and technical inspection prescribed in Clause 10, Article 70 of Decree No. 98/2021/ND-CP;
dd) The list of medical devices being granted import licenses as prescribed at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP.
2. Announcing the invalidity of a number of legal documents on the management of medical devices.
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