IVD Medical Device Registration in Vietnam
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.
IVD Medical Device Registration Support for Regulatory Compliance – Vietnam
Vietnam’s in-vitro diagnostics (IVD) market is experiencing significant growth, driven by increasing demand for early disease detection, preventive healthcare, and improvements in medical technology and healthcare infrastructure. As the need for diagnostic testing expands, regulatory oversight plays an important role in ensuring device safety and quality. In Vietnam, the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health regulates the registration of IVD devices.
At Andaman Medical, our regulatory affairs specialists provide comprehensive support throughout the IVD registration process. From initial device classification and regulatory submission to post-market compliance, we help ensure your IVD devices meet the regulatory requirements established by the Vietnamese government.
Why Register Your IVD Medical Device in Vietnam?
Registering your IVD device in Vietnam enables manufacturers to access one of Southeast Asia’s rapidly growing healthcare markets. Compliance with national regulatory requirements ensures that diagnostic devices can be legally distributed while supporting the country’s increasing demand for reliable diagnostic technologies.
Registering your IVD device in Vietnam offers numerous strategic advantages:
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.
Registration Process Overview
Here’s a step-by-step overview to navigating the IVD registration process in Vietnam:
Classification
Submission
Evaluation
ApprovalClassification
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
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.
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.
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.
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia