12 MEDICAL DEVICES SERVING COVID-19 PANDEMIC PREVENTION AND CONTROL IN EMERGENCY CASES
The Ministry of Health issues the Circular No. 06/2022/TT-BYT defining the list and issuance of registration numbers of medical devices serving COVID-19 pandemic prevention and control in emergency cases on August 01, 2022.
Accordingly, the Ministry of Health promulgates the list of 12 medical devices serving COVID-19 pandemic prevention and control in emergency cases as specified in Clause 3, Article 29 of the Decree No. 98/2021/ND-CP. A number of medical devices in the list shall be: High-performance ventilator, invasive and non-invasive ventilator, non-invasive ventilator, HFNC oxygen machine, portable ventilator; PCR machine; Chemicals (biological products) for operation of PCR machines for testing for SARS-CoV-2.
Additionally, SARS-CoV-2 rapid antigen/antibody test kit; continuous renal replacement therapy (CRRT) machine; mobile X-ray equipment; blood gas analyzer (that may measure electrolytes, lactate, hematocrit); patient monitor with ≥ 5 parameters; electric syringe pump, infusion pump; defibrillators with pacing option; blood clotting time testing machine; and cardiac output monitor are also in the above-mentioned list.
Besides, the form of certificates of registration of type-C and type-D medical devices serving COVID-19 pandemic prevention and control in emergency cases is added in this Circular.
This Circular takes effect on August 01, 2022.
