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 promulgated 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.
