17 medical equipment to fight against COVID-19 quickly issued with circulation numbers in Vietnam

17 medical equipment to fight against COVID-19 quickly issued with circulation numbers in Vietnam 

Specifically include:

- Extraction machine;

- PCR machine;

- Chemicals (biological products) running the SARS-CoV-2 PCR test machine;

- Rapid test kit for antigen/antibody against SARS-CoV-2;

- High-function ventilators, invasive and non-invasive ventilators, non-invasive ventilators, high-flow oxygen machines, portable ventilators;

- Continuous dialysis machine;

- Portable X-ray machine;

- Color Doppler ultrasound machine ≥ 3 probes;

- Blood gas meter (measuring electrolytes, lactate, hematocrite);

- Patient monitor ≥ 5 parameters;

- Electric injection pump;

- Infusion machine;

- Pacemaker defibrillator;

- ECG machine ≥ 6 channels;

- Portable ultrasound machine;

- Coagulation time meter;

- Hemodynamic meter.

The Ministry of Health of Vietnam stipulates that medical equipment may apply the form of fast issuance of free-sale registration numbers if it simultaneously meets the following conditions:

(1) Belonging to the list specified in Appendix 1 issued together with Circular 13/2021/TT-BYT ;

(2) Belongs to one of the following cases:

- Approving for circulation or emergency use by one of the following organizations: US Food and Drug Administration (FDA) - USA; Therapeutic Goods Administration (TGA) - Australia; Health Canada (Health Canada); Japan's Ministry of Health, Labor and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) - Japan;

- Be approved by the competent authorities of the European countries specified in Appendix 2 to Circular 13/2021 for circulation and emergency use;

- Belongs to the list of emergency-use SARS-CoV-2 testing products announced by WHO on its website at https://extranet.who.int  (Coronavirus disease (COVID-19) Pandemic —Emergency Use Listing Procedure (EUL) open for IVDs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control););

- Belonging to the list of popular products for testing for SARS-CoV-2 issued by the European Health Security Committee (EUHSC) published on its website at https://ec. europa.eu  (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu)

- Be granted a commercial import license in Vietnam before September 16, 2021;

- Be produced domestically in the form of technology transfer, for medical equipment falling into one of the above cases;

- Be produced domestically in the form of processing for medical equipment in one of the cases mentioned above.

Note: 

- The circulation number of the issued medical equipment includes:

+ The certification number of the Department of Medical Equipment and Medical Works on the standard announcement document, made according to form No. 1 specified in Appendix 3 issued together with Circular 13/2021 of Vietnam, for medical equipment economy of categories B

+ Number of circulation registration certificate for medical equipment issued by the Department of Medical Equipment and Medical Works according to the form specified in Appendix 4 issued with Circular 13/2021 for medical equipment economy of categories C, D.

- Value of circulation number: The issued circulation number is valid in Vietnam from September 16, 2021 to December 31, 2022.

 Bao Ngoc

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