Medical Device Registration and Approval in Vietnam

General country-specific regulatory information is provided on this page for medical device registration and approval in Vietnam. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Vietnam, to expedite the preparation of your medical device or IVD registration application.

Medical device regulations and classification in Vietnam

REGULATORY AUTHORITY: Department of Medical Equipment and Construction (DMEC)

CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D

TIMEFRAME:

Official Timeline

Device Classification – 7 working days

New registration (have an applicable national technical standard): 15 working days

New registration (do not have an applicable national technical standard): 60 working days

New registration (fast track “quick issuance”): 30 working days

Import License (registration for devices under Circular 30): 25 working days

Actual Timeline (based on experience)

Device Classification – 30 days

Import License (registration for devices under Circular 30): 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)

Until 30 June 2021 (reduced fees due to COVID-19 pandemic)

MD/IVD Class A – USD 30

MD/IVD Class B – USD 91

MD/IVD Class C/D – USD 152

Import License (registration for devices under Circular 30) – up to USD 61

As of July 2021

MD/IVD Class A – USD 45

MD/IVD Class B – USD 135

MD/IVD Class C/D – USD 225

Import License (registration for devices under Circular 30) – up to USD 187

LOCAL FEES (Manufacturer): Not Applicable

LICENSE VALIDITY: Unlimited (for class A); 5 years (for Class B/C/D).

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, starting on January 1, 2022, Circular 30 will becomes obsolete and both Decree 36 and 169 will be fully implemented including ASEAN Common Submission Dossier Template (CSDT).

Last updated on April 20 2021.

For more information on Medical Device Registration in Vietnam, check out the following articles on our blog!

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand

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