IVD Medical Device Registration in Vietnam

The In Vitro Diagnostics (IVD) market in Vietnam is experiencing significant growth due to increasing customer preferences for early disease detection and prevention, as well as advancements in technology and healthcare infrastructure. This growing demand has led to a rise in the need for diagnostic tests. The Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health regulates the registration of IVD devices to ensure their safety, efficacy, and quality.

Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the Vietnamese government.

Why Register Your IVD Medical Device in Vietnam?

Registering your IVD device in Vietnam offers numerous strategic advantages

Our IVD Medical Device Registration Services

Regulatory Strategy

Customised regulatory strategy tailored to optimise the registration process for your IVD device in Vietnam.

Dossier Preparation

Compiling and reviewing all necessary documentation based on the guidelines.

Submission Management

Managing the entire submission process, including communication with the Vietnamese Ministry of Health.

Post-Market Compliance

Assist in adverse event reporting, change notifications and more.

Registration Process Overview

Here’s a step-by-step overview to guide you through registering your IVD medical device in Vietnam:

Step 1: Classification

Medical devices in Vietnam are classified based on risk according to the ASEAN Medical Device Directive (AMDD) which are:

  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk 
  • Class D: High Risk 

Step 2: Submission

Various legal and technical documents are required to register a medical device in Vietnam: 

Legal Documents: 

  • Free Sale Certificate 
  • Letter of Authorization
  • ISO 13485 Certificate
Technical Documents: 
  • Classification Result
  • Technical Brief
  • Instructions for Use (in Vietnamese) 
  • Labeling
  • Catalogue
For medical devices classified as Class C and D and invasive in the human body, a summary of clinical trial data is also required. The classification of the medical device must be determined by the applicant or licence holder. 

All applications for Class A, B, C and D devices must be submitted to the DMEC via the online portal. 

Step 3: Evaluation

The registration applications are evaluated following the guidelines under Decree 98/2021/ND-CP. Once the necessary documentation on product classification and group has been uploaded, the registrant can process the payment simultaneously.

Step 4: Approval

Upon successful evaluation, the appropriate certification is issued:

  • Class A and B: A Notification of Applicable Standard will be issued, which has lifetime validity. 
  • Class C and D: A Circulation Registration Certificate (product license) will be issued. This certificate does not have a lifetime validity.

Step 1: Classification

Medical devices in Vietnam are classified based on risk according to the ASEAN Medical Device Directive (AMDD) which are:

  • Class A: Low Risk
  • Class B: Low to Moderate Risk
  • Class C: Moderate to High Risk 
  • Class D: High Risk 

Step 2: Submission

Various legal and technical documents are required to register a medical device in Vietnam: 

Legal Documents: 

  • Free Sale Certificate 
  • Letter of Authorization
  • ISO 13485 Certificate
Technical Documents: 
  • Classification Result
  • Technical Brief
  • Instructions for Use (in Vietnamese) 
  • Labeling
  • Catalogue
For medical devices classified as Class C and D and invasive in the human body, a summary of clinical trial data is also required. The classification of the medical device must be determined by the applicant or licence holder. 

All applications for Class A, B, C and D devices must be submitted to the DMEC via the online portal. 

Step 3: Evaluation

The registration applications are evaluated following the guidelines under Decree 98/2021/ND-CP. Once the necessary documentation on product classification and group has been uploaded, the registrant can process the payment simultaneously.

Step 4: Approval

Upon successful evaluation, the appropriate certification is issued:

  • Class A and B: A Notification of Applicable Standard will be issued, which has lifetime validity. 
  • Class C and D: A Circulation Registration Certificate (product license) will be issued. This certificate does not have a lifetime validity.

Typical Fees and Timeline

For medical device and IVD new registrations and import licenses:
Class Fee Timeline
Class A 1,000,000 VND (~44 USD) 7-10 working days
Class B 3,000,000 VND (~130 USD) 7-10 working days
Class C and Class D 5,000,000 VND (~217 USD) 6-12 months

Why Choose Andaman Medical as Your IVD Consultant in Vietnam?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for IVD registration and market access in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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