Circular 06/2022/TT-BYT list of medical devices serving COVID-19 pandemic prevention and control in emergency cases

CIRCULAR

Defining the list and issuance of registration numbers of medical devices serving COVID-19 pandemic prevention and control in emergency cases

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Pursuant to the Government's Decree No. 75/2017/ND-CP dated June 20, 2017 on 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 08, 2021, on the management of medical devices;

At the request of the Director of the Department of Medical Equipment and Works;

The Minister of Health promulgates the Circular defining the list and issuance of registration numbers of medical devices serving COVID-19 pandemic prevention and control in emergency cases.
 

Article 1. List of medical devices serving COVID-19 pandemic prevention and control in emergency cases as specified in Clause 3, Article 29 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021, on the management of medical devices

1. PCR machine.

2. Chemicals (biological products) for operation of PCR machines for testing for SARS-CoV-2.

3. SARS-CoV-2 rapid antigen/antibody test kit.

4. High-performance ventilator, invasive and non-invasive ventilator, non-invasive ventilator, HFNC oxygen machine, portable ventilator.

5. Continuous Renal Replacement Therapy (CRRT) machine.

6. Mobile X-ray equipment.

7. Blood gas analyzer (that may measure electrolytes, lactate, hematocrit).

8. Patient monitor with ≥ 5 parameters.

9. Electric syringe pump; Infusion pump.

10. Defibrillators with pacing option.

11. Blood clotting time testing machine.

12. Cardiac output monitor.

Article 2. To add certificates of registration of type-C and type-D medical devices serving COVID-19 pandemic prevention and control in emergency cases

To add the form of certificates of registration of type-C and type-D medical devices serving COVID-19 pandemic prevention and control in emergency cases (that is specified in Appendix I to this Circular).

Article 3. Effect

1. This Circular takes effect on August 01, 2022.

2. The Minister of Health’s Circular No. 13/2021/TT-BYT dated September 16, 2021 defining the issuance of registration numbers and importation of medical devices serving COVID-19 pandemic prevention and control in emergency cases ceases to be effective from the effective date of this Circular.

Article 4. Transitional provisions

Dossiers of request for grant of certificates of registration of type-C and type-D medical devices serving COVID-19 pandemic prevention and control that have been received by the Ministry of Health before January 01, 2022 shall continue to be settled in accordance with the Minister of Health’s Circular No. 13/2021/TT-BYT dated September 16, 2021 defining the issuance of registration numbers and importation of medical devices serving COVID-19 pandemic prevention and control in emergency cases.

Article 5. Organization of implementation

Chief of the Ministry Office; Chief Inspector of the Ministry; Directors, Director General under the Ministry of Health; Directors of Health Department of provinces and centrally-run cities and relevant agencies, organizations and individuals shall be responsible for the implementation of this Circular.

Any problem arising in the course of implementation shall be promptly reported to the Ministry of Health for consideration and settlement./.

For the Minister

The Deputy Minister

Do Xuan Tuyen

* All Appendices are not translated herein.