With the emergence of COVID-19 pandemic, the Ministry of Health is continuing its effort to control the epidemic by adjusting its regulations. On August 1, 2022, the Ministry of Health has issued Circular No. 06/2022/TT-BYT defining the list and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases.
This circular replaces the previously issued Circular No. 13/2021/TT-BYT dated September 16, 2021, which listed 17 Medical Devices used in the prevention and control of COVID-19 in emergency cases. Based on the new circular, the medical device list is further decreased to 12 which includes the following:
- PCR machine.
- Chemicals (biological products) running the SARS-CoV-2 PCR machine.
- Rapid test kit for antigen/antibody against SARS-CoV-2.
- High-function ventilator, invasive and non-invasive ventilator, non-invasive ventilator, high flow oxygen machine, portable ventilator.
- Continuous dialysis machine.
- Portable X-ray machine.
- Blood gas meter (measuring electrolytes, lactate, hematocrite).
- Patient monitor ≥ 5 parameters.
- Electric syringe pump; Infusion pump.
- Pacemaker defibrillator.
- Coagulation time meter.
- Hemodynamic meter.
On the other note, registration applications for Class C and D Medical Devices intended for prevention and control of COVID-19, accepted by Ministry of Health before 01 January 2022, shall be processed in emergency route as stated in Circular No. 13/2021/TT-BYT.
If you have any queries regarding this announcement, please contact us.