“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.”

David Vo
General Manager
Asia Actual VietNam

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

VietNam Expedites Registration of COVID-19 Related Medical Devices

Published on: October 4th, 2021

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.

Come Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market.

Contact Asia Actual today with any questions or support requests.

Blog Posts

The Philippines FDA Issues Guidance for Retailers of Medical Devices

On October 7, 2021, the Philippines FDA released FDA Circular No.2021-0021. The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts.

Thai FDA Updates Medical Devices Applications Fees

On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes.

India Temporarily Suspends Compulsory Medical Device Registrations

In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.