Vietnam: The Registration of Covid-19 Related Medical Devices in Vietnam is Expedited

ARQon
Dec 17, 2021
2 min read

Vietnamese Ministry of Health has published a new Circular 13/2021/TT-BYT on 16 September 2021. This circular provided an expedited review process for a number of medical devices related to Covid 19. The application will be reviewed in 10 days and will need to be renewed by the end of 2022.

Products indexed as critical to preventing COVID-19 and are eligible for expedited registration paths 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. Colour Doppler ultrasound machine (3 probes)

9. Blood gas meter (measuring electrolytes, lactate, and haematocrits)

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

To be eligible for this registration process, products must meet one of the following criteria:

a) One of the following organisations has given permission for it to circulate or be used (US FDA, TGA, Health Canada, MHLW, PMDA)

b) It has been approved for circulation and emergency use by the competent authorities of the European countries listed in Appendix 2 to this Circular.

c) Belonging to the World Health Organization's list of SARS-CoV-2 testing products that must be used immediately (WHO)

d) It has been included to the list of popular products for testing SARS-CoV-2 issued by the European Health Security Committee (EUHSC)

e) Before the implementation date of this Circular, you were given a commercial import licence in Vietnam South.

f) Produced domestically through technology transfer and meets the criteria listed in points a) through e).

g) Produced domestically in the form of processing for the medical equipment industry, and fits the criteria listed in points a) through e).

This method allows new manufacturers with established goods to enter the Vietnamese market rapidly and contribute to the fight against COVID while also establishing themselves in a developing market.

Sources:

Circular 13/2021/TT-BYT