New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management

Healthcare Medical Tester

Circular No. 13/2021/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale registration numbers for medical devices, medical supplies, biological products, and chemicals used in COVID-19 prevention and control, including:

Extraction machine; PCR machine; chemicals (biological products) running a PCR machine to test for 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, hematocrite); patient monitor ≥ 5 parameters; electric injection pump; infusion machine; pacemaker defibrillators; ECG machine ≥ 6 channels; portable ultrasound machine; coagulation time meter; hemodynamic meter.

Affective period: 16/09/2021 – 31/12/2022

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