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
Import License (registration for devices under Circular 30): 1 – 3 months
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
Import License (registration for devices under Circular 30) – up to USD 195
LOCAL FEES (Manufacturer): Not Applicable
LICENSE VALIDITY:
Registration certificate: Unlimited (for class A); 5 years (for Class B/C/D).
Import license (registration for devices under Circular 30): up to 1 year.
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: Devices listed under Circular 30 are subject to apply for import license. While devices not listed in Circular 30, are subject to apply for product license. However, the circumstances that Circular 30 will soon be fully replaced by Decree 36 in January 2022, all import licenses under Circular 30 is not subject to renewal and will be valid only until 31 December 2022. Starting on January 1st, 2022, both Decree 36 and 169 will be fully implemented including ASEAN Common Submission Dossier Template (CSDT).
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!
