Vietnam MoH

Vietnam Medical Device Registration

The medical device market in Vietnam is one of the fastest growing in the Asian region due to the government's recent hospital improvement efforts. More than 90% of medical devices in Vietnam are imported. Qualtech  is your ideal partner for your foray into the Vietnam medical device market for an easy and smooth registration process.

Qualtech in Vietnam

Expert in Non-Active Device

Our team has assisted with various kinds of medical devices to access Vietnam market efficiently. Our experience covers contact lens, facial filler, adhesive gel, sterilizers and consumable products, cranial saw drilling system, and other devices.

Market Access Strategy

Qualtech Vietnam team offer clients ONE-STOP market access service, covering Regulatory research, Registration, Importation, Distributor connection.



QT Services

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with IMDA officers to get your devices registered in the Vietnam.


Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in Vietnam. This is in compliance with the law for a local establishment to be a license holder.



The local distributor you are looking at is sometimes not a qualified importer, or is not familiar with the importation process of medical devices. Qualtech has extensive experience in importation in many regions of Asia, assisting several customers to handle customs clearance of various medical equipment imports. We can assist your products be delivered to customers smoothly!


Registration with IMDA

Ministry of Health (MoH) is the Institution to manage medical device affairs. Under MoH, the Infrastructure and Medical Device Administration (IMDA) and Department of Health (DoH) are the regulatory body that governs the registration and approval of all medical devices. In old regulation, the registrant might obtain Import Permit License for particular medical devices to import medical device into Vietnam. The New Medical Device Regulation, issued in 2021 and applied since 2022, requires medical devices to be registered before importation and marketing in Vietnam.


Major Change in New Regulation:

  • Class B medical devices need to obtain a Declaration of applicable standards instead of a Certificate of registration for circulation.
  • The registrant shall refer to CSDT regulation to submit the technical document during Class C and D registration. 




Executive Summary     Yes Yes
Essential Principles and Methods     Yes Yes
Device Description Yes Yes Yes Yes
Summary of Design V&V     Yes Yes
Labeling and IFU Yes Yes Yes Yes
Risk Assessment     Yes Yes
Physical Manufacturer Information Yes Yes Yes Yes
Summary of clinically testing data     Yes Yes
PMS Report     Yes Yes
Declaration of Conformity Yes Yes    

Note: Kindly see the Decree 98/2021/ND-CP and Decree 07/2023/ND-CP for more details. From 2021, Class C and Class D medical device registration in Vietnam will not require CSDT until 2024. The CSDT must be applied as of January 1st, 2024.


DoH/IMDA Target Reviewing Evaluation Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the DoH/IMDA and will be subjected to thorough evaluation. Below is a list of the evaluation times for different types of transactions involving product registration/notification.

Note: It's accounted as calendar days.
Registration refers to the period between submission and the first input request. Compliance refers to the allowable time for registrant preparing compliance documents.

  • Types of Certificates: 

    • •    Class A & B: Declaration of applicable standards for medical device
    • •    Class C & D: Certificate of registration for circulation
    • Validity of product certificate of class A, B, C, D: Permanent
How Could I Obtain Faster Market Access?

According to the new regulation, the threshold of accessing Vietnam market becomes higher. Every foreign manufacturer would like to have their product access Vietnam market immediately. The good news is that IMDA offers TWO routes of faster market access to shorten the registration timeline.



The product has been registered in one of the following countries: Japan, Canada, Australia, United States, EU member countries, Switzerland, England, China, and Korea.

The medical device has been granted import licenses, registration numbers, or certificates of registration in commercial form in Vietnam, unless the certificate is revoked.

For more information, please refer to the Vietnam IMDA's official website or you may contact us for a free consultation.

Official Website