REGULATORY AUTHORITY: Department of Medical Equipment and Construction (DMEC)
CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D
TIMEFRAME:
Official Device Classification – 10 working days
Product registration (regular pathway): 10-12 months
Product registration (quick issuance/fast-track): 2-4 months
SPECIAL REQUIREMENTS: Medical devices that are listed by the MoH, such as measuring devices or radiation equipment must be tested and calibrated locally.
Local clinical trial might be required for the importation of medical devices that have never been registered in Vietnam, especially for medium to high-risk medical device classes (except the product that has been circulated and granted an FSC in one of the following countries: EU member state, Japan, Canada, Australia, or the USA).
LOCAL FEES (New Application):
MD/IVD Class A – USD 50
MD/IVD Class B – USD 135
MD/IVD Class C/D – USD 225
LICENSE VALIDITY:
Registration certificate: Unlimited (for class A); 5 years (for Class B/C/D).
Import license (registration for devices under Circular 30): Given the circumstances that Circular 30 has been replaced by Decree 36 in January 2022, all import licenses under Circular 30 are not subject to renewal and.as per the Decree 07/2023/ND-CP on Management of Medical Equipment (March 2023):
· Import licenses for medical equipment other than IVDs issued from January 1, 2018 to January 31,2021 shall continue to be used until December 31, 2024;
· Import licenses for IVDs issued from January 1, 2018 to December 31, 2021 shall continue to be used until December 31, 2024 and without limiting the import quantity;
LICENSE TRANSFER: License transfer is not possible; hence a new registration would be required.
AUTHORIZED REPRESENTATIVE: A foreign manufacturer must appoint an authorized representative (AR) to register their medical device in Vietnam.
ADDITIONAL INFORMATION:
Starting from January 2022, Circular 30 has been revoked hence import license would no longer be required.
Quick issuance is the registration pathway for devices that have been circulated in at least 1 of the following countries: Japan, Canada, Australia, USA, or EU member countries.
For more information on Medical Device Registration in Vietnam, check out the following articles on our blog!
