Thông tư 06/2022/TT-BYT của Bộ Y tế về việc quy định danh mục và cấp số lưu hành trang thiết bị y tế phục vụ phòng, chống dịch COVID-19 trong trường hợp cấp bách

CIRCULAR

LIST AND REGISTRATION NUMBER OF MEDICAL EQUIPMENT SERVING COVID-19 CONTROL IN CASE OF EMERGENCIES

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;

Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical equipment;

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

Minister of Health promulgates Circular on list and registration number of medical equipment serving COVID-19 control in case of emergencies.

Article 1. List of medical equipment serving COVID-19 control in case of emergencies according to Clause 3 Article 29 of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical equipment

1. PCR machine.

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

4. Intensive care ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high-flow nasal cannula.

5. Continuous hemodiafiltration machines.

6. Mobile X-ray machines.

7. Blood gas analyzers (capable of measuring electrolytes, lactates, hematocrite).

8. 5-parameter patient monitoring machines.

9. Electric syringe pump; Infusion pump.

10. Implantable Cardioverter-Defibrillators.

11. Coagulation timer.

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Article 2. Adding certificate of registration of class C and class D medical equipment serving COVID-19 in case of emergencies

Add certificate of registration of class C and class D medical equipment serving COVID-19 control in case of emergencies (under Appendix I attached hereto).

Article 3. Entry into force

1. This Circular comes into force from August 01, 2022.

2. Circular No. 13/2021/TT-BYT dated September 16, 2021 of the Minister of Health expires from the effective date hereof.

Article 4. Transition clauses

Application for certificate of registration for class C and class D medical equipment serving COVID-19 control received by the Ministry of Health before January 1, 2022 shall be processed in accordance with Circular No. 13/2021/TT-BYT dated September 16, 2021 of the Minister of Health.

Article 5. Organizing implementation

Chief of the Ministry Office, Chief Ministry Inspectorates, Directors, General Directors affiliated to the Ministry of Health, Directors of Departments of Health of provinces and central-affiliated cities and other relevant organizations and individuals are responsible for the implementation of this Circular.

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PP. MINISTERDEPUTY MINISTERDo Xuan Tuyen