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

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ATTRIBUTE

Circular No. 06/2022/TT-BYT dated August 01, 2022 of the Ministry of Health defining the list and issuance of registration numbers of medical devices serving COVID-19 pandemic prevention and control in emergency cases
Issuing body: Ministry of HealthEffective date:
Known

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Official number:06/2022/TT-BYTSigner:Do Xuan Tuyen
Type:CircularExpiry date:Updating
Issuing date:01/08/2022Effect status:
Known

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Fields:Medical - Health

SUMMARY

12 medical devices serving COVID-19 pandemic prevention and control in emergency cases

On August 01, 2022, 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.

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.

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Effect status: Known

THE MINISTRY OF HEALTH

_____

No. 06/2022/TT-BYT

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

______________________

Hanoi, August 01, 2022

 

 

CIRCULAR

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

________

 

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.

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Food and drug , Medical - Health

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