Regulatory Update: Determination of the List and Issuance of Circulation Numbers for Medical Devices for COVID-19 Prevention and Control

On August 1, 2022, Vietnam's Ministry of Health released Circular No. 06/2022/TT-BYT, which outlines the determination of the list and the issuance of circulation numbers for medical devices intended for the prevention and control of COVID-19 in urgent cases.

Article 1 of the circular specifies a list of medical equipment necessary for urgent COVID-19 prevention and control efforts. This includes:

• PCR machines and associated bio-products for testing SARS-CoV-2
• Rapid antigen and antibody tests for SARS-CoV-2
• High-function ventilators, both invasive and non-invasive
• High-flow oxygen machines
• Portable ventilators
• Continuous dialysis machines
• Portable X-ray machines
• Blood gas detectors (for measuring electrolytes, lactate, and hematocrit)
• Patient monitors with five parameters
• Electric syringes
• Infusion pumps
• Pacemakers
• Coagulation timers
• Hemodynamic meters

To facilitate the prevention and control of COVID-19 in urgent situations, it is essential to complete the registration certificate for the circulation of medical devices classified as C and D. This circular is effective as of August 1, 2022. The issuance of circulation numbers and the importation of medical devices for COVID-19 prevention and control will conclude on the date this circular is issued.