With the release of Circular 13/2021/TT-BYT on September 16, 2021, the VietNamese Ministry of Health has provided a new, expedited review process for specified medical devices related to COVID-19. Qualifying applications will be reviewed in 10 days and will need to be renewed by the end of 2022. Products listed as essential to fighting COVID-19 and are eligible for an expedited registration route are:

1. Extraction machine
2. PCR machine
3. Chemicals (biological products) used with the PCR machine to test for SARS-Co V-2
4. Anti-SARS-Co V-2 antigen/antibody rapid test kits
5. Invasive and non-invasive ventilators (high function, high flow, portable, etc.)
6. Continuous dialysis machine
7. Portable x-ray machine
8. Color Doppler ultrasound machine (3 probes)
9. Blood gas meter (measuring electrolytes, lactate, and hematocrits)
10. Patient monitor (5 parameters)
11. Electric injection pump
12. Infusion machine
13. Pacemaker/Defibrillator
14. Electrocardiogram (6 channels)
15. Portable ultrasound machine
16. Coagulation time meter
17. Hemodynamic meter

Qualifying Products

Not all products will be reviewed under the fast track, abbreviated review process in VietNam. Products must meet one of the following to submit under this registration route:

1. Has been allowed to circulate or use by one of the following organizations (US FDA, TGA, Health Canada, MHLW, PMDA)
2. It has been regulated by the competent authorities of the European countries specified in Appendix 2 to this Circular for permission for circulation and emergency use;
3. Belonging to the list of SARS-CoV-2 testing products that are used urgently issued by the World Health Organization (WHO)
4. Belonging to the list of popular products for testing SARS-CoV-2 due to issued by the European Health Security Committee (EUHSC)
5. Having been granted a commercial import license in VietNam South before the effective date of this Circular
6. Produced domestically in the form of technology transfer and meets criteria mentioned in points a) through e)
7. Produced domestically in the form of processing for medical equipment economy and meets criteria mentioned in points a) through e)

This process provides new manufacturers with established products the opportunity to quickly enter the VietNamese market and help with the COVID fight while also establishing themselves in a growing market of 100 million people.

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