Laboratory technician processing PCR C*vid-19 tests

Vietnam Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

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:

  1. PCR machine.
  2. Chemicals (biological products) running the SARS-CoV-2 PCR machine.
  3. Rapid test kit for antigen/antibody against SARS-CoV-2.
  4. High-function ventilator, invasive and non-invasive ventilator, non-invasive ventilator, high flow oxygen machine, portable ventilator.
  5. Continuous dialysis machine.
  6. Portable X-ray machine.
  7. Blood gas meter (measuring electrolytes, lactate, hematocrite).
  8. Patient monitor ≥ 5 parameters.
  9. Electric syringe pump; Infusion pump.
  10. Pacemaker defibrillator.
  11. Coagulation time meter.
  12. 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.

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