On September 16, 2021, the Minister of Health promulgated Circular No. 13/2021/TT-BYT stipulating the issuance of circulation numbers and the import of medical equipment to serve the prevention and control of COVID-19 in case of urgent.

Accordingly, medical equipment may apply the form of fast issuance of free registration numbers if the following conditions are satisfied at the same time:

As medical equipment for the prevention and control of the COVID-19 epidemic, the circulation number is quickly issued on the list of regulations, including Extraction machine; PCR machine, Chemicals (biological products) running the PCR machine for testing SARS-CoV-2; 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, hematocrit); Patient monitor ≥ 5 parameters; Electric injection pump; Infusion machine; Pacemaker defibrillators; ECG machine ≥ 6 channels; Portable ultrasound machine; Coagulation time meter; Hemodynamic meter.

Belongs to one of the following cases:

1. Has been approved 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;
2. Has been approved by the competent authorities of the European countries for circulation and emergency use;
3. Belongs to the list of SARS-CoV-2 testing products for emergency use announced by the World Health Organization (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 Imm unification Devices, Vector Control);
4. Belongs 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);
5. Having been granted a commercial import license in Vietnam before the effective date of this Circular (September 16, 2021);
6. Produced domestically in the form of technology transfer for medical equipment in one of the following cases (1), (2), (3), ( 4), (5) above;
7. Produced domestically in the form of processing for medical equipment in one of the following cases (1), (2), (3), (4), (5) above.

This Circular takes effect from September 16, 2021.