IVD Medical Device Registration in Vietnam
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?
Regulatory Compliance
Regulatory Compliance
Registering your IVD device in Vietnam ensures compliance with local regulatory requirements, which is crucial for legal marketing and distribution. Adhering to the regulations set by the government demonstrates your commitment to quality and safety, enhancing your brand’s reputation.
Market Access and Distribution
Market Access and Distribution
Registration facilitates smoother market access and distribution of your IVD devices across Vietnam. With proper registration, you can avoid potential legal issues, delays, and disruptions in supply chains, ensuring that your products reach healthcare providers efficiently.
Partnering Opportunities
Partnering Opportunities
Vietnam’s growing healthcare sector is attracting numerous local and international investors and partners. Having your IVD device registered can open doors to strategic partnerships with local distributors, hospitals, and clinics, further enhancing your market penetration and business growth.
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
- Classification Result
- Technical Brief
- Instructions for Use (in Vietnamese)
- Labeling
- Catalogue
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
- Classification Result
- Technical Brief
- Instructions for Use (in Vietnamese)
- Labeling
- Catalogue
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
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 |