Vietnam introduces fast track registrations for Covid 19 products

Vietnam introduces fast track importation of certain products related to COVID-19 prevention

Vietnam’s Ministry of Health introduced new regulations on 16 September 2021 regulating the issuance of fast-track product licenses and the importation of medical equipment for COVID-19 prevention and control. Circular No. 13/2021/TT-BYT immediately came into effect from the date of signing and is effective until 31 December 2022. The Circular includes a list of products used in the prevention and control of the COVID-19 epidemic as well as the procedures to apply for Product Licenses, Product Registrations (classes B, C, and D), and importation.   


List of applicable products for fast-track applications under the Circular No. 13/2021/TT-BYT

The following medical equipment listed below as well as medical supplies, biological products, and chemicals used in the prevention and control of the COVID-19 epidemic can apply for a Product License using a fast-track route. The official list can be referred to in Clause 1 of Appendix 1 issued together with this Circular.


Name of medical device




PCR Machine


Chemicals (biological products) running a PCR machine to test for SARS-CoV-2


Rapid test kit for antigens/antibodies against SARS-CoV-2


High-function ventilators, invasive and non-invasive ventilators, high-flow oxygen machines, portable ventilators


Continuous dialysis machine


Portable X-ray machine


Color Doppler ultrasound machine with 3 or more transducers


Blood gas meter (measuring electrolytes, lactate, hematocrit)


Patient monitor with 5 or more parameters


Electric Syringe


Infusion Machine


Pacemaker cardiac vibrator


ECG machine with 6 channels or more


Portable ultrasound machine


Blood clotting time meter


Hemodynamic meter

Concerned parties may apply for fast issuance of Product Licenses if the medical equipment meets the following conditions:

  1. Is listed in Appendix 1 issued together with the Circular;
  2. AND one of the following applies:

a) The medical equipment has been approved for circulation or emergency use by one of the following organizations:

  • US Food and Drug Administration (FDA) – USA;
  • Therapeutic Goods Administration (TGA) – Australia;
  • Health Canada (Health Canada);
  • Japan’s Ministry of Health, Labor and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) – Japan;

b) It has been regulated by the competent authorities of the European Union for permission for circulation and emergency use;

c) It is listed as one of the SARS-CoV-2 testing products for emergency use as published by the World Health Organization (WHO) on its website at (Coronavirus disease (Coronavirus disease) COVID-19) Pandemic — Emergency Use Listing Procedure (EUL) open for IVDs | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control);

d) It is listed as one of the popular products for testing for SARS-CoV-2 issued by the European Health Security Committee (EUHSC) published on its website at https://ec (Technical working group on COVID-19 diagnostic tests | Public Health (;

dd) It has been granted an import license in commercial form in Vietnam prior to the effective date of this Circular;

e) It is domestically produced in the form of technology transfer or processing for medical equipment falling into one of the cases specified at Points a, b, c, d or dd of this Clause.

In essence, the above listed products must still apply for Circulation Numbers from the Department of Medical Equipment and Construction according to their class however these will be on a fast-track basis:

  • Circulation Number for Class B products is called a Declaration of Applied Standards
  • Circulation Number for Classes C and D is called a Registration Certificate.

However, there are cases when a Circulation Number is not required:

  1. When goods are imported for scientific research or testing or to guide the use and repair of medical equipment
  2. When goods are imported for aid purposes
  3. When goods are imported for personal medical use.

For more information

If you wish to know more about how these regulations apply to your product please contact the Regulatory Affairs Specialist in charge of your dossier or contact us via the button below.

If you have any queries regarding registrations, market authorizations or our services for medical device registration and representation in Vietnam, please click on the button below.

To learn more about registering medical devices in Vietnam click here.

To learn more about the medical device market in Vietnam click here.

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