Vietnam is one of the fastest-growing healthcare markets in Southeast Asia, making it an attractive destination for global medical device manufacturers. With a population exceeding 98 million and a healthcare system undergoing modernization, the demand for advanced medical technologies is rising steadily. Medical device imports make up more than 90% of the market, opening a significant window of opportunity for international players, provided they understand and comply with the country’s evolving regulatory landscape.
Vietnam Medical Device Market: An Overview
Vietnam’s medical device market was valued at USD 1.7 billion in 2024, making it the eighth-largest in the Asia-Pacific region. According to Fitch Solutions, the sector is projected to grow at a compound annual growth rate (CAGR) of 9.5% from 2022 to 2027, driven by public and private investments in healthcare infrastructure, an aging population, and the increasing burden of non-communicable diseases.
The most commonly imported medical device categories include consumables, diagnostic imaging equipment, dental products, orthopedics and prosthetics, and patient aids.
Given Vietnam’s reliance on imported devices, foreign manufacturers have ample opportunity to introduce new technologies to the market. However, accessing the market requires compliance with the country’s structured regulatory pathway for medical device registration.
Who Can Register Medical Devices in Vietnam?
Only local entities can directly register medical devices with the Ministry of Health (MOH) or the Department of Health (DOH). Foreign manufacturers must either establish a legal presence in Vietnam or appoint an authorized local representative. Eligible Vietnamese registrants include:
- Vietnamese companies and cooperatives
- Household businesses licensed to trade in medical devices
- Local representative offices of foreign traders authorized to register devices
Options for Foreign Manufacturers:
- Establish a Legal Entity in Vietnam
Companies may set up a subsidiary and obtain the necessary investment and business licenses from the local Department of Planning and Investment. This route allows for full control but involves a longer setup process and greater regulatory obligations. - Appoint a Local Importer or Distributor
A quicker alternative is to designate a local distributor who already holds an establishment license. This distributor can register the products on the manufacturer’s behalf and handle importation and distribution. - Engage a Third-Party Local Authorized Representative
Independent consulting companies can act as Local Authorized Representatives (LARs) and hold valid medical device establishment licenses. They handle the entire registration process for all device classes and provide regulatory support while allowing manufacturers to retain flexibility in choosing downstream importers or wholesalers.
Classification of Medical Devices in Vietnam
Vietnam categorizes medical devices into four classes based on risk:
- Class A – Low risk
- Class B – Low to moderate risk
- Class C – Moderate to high risk
- Class D – High risk
The classification determines the type of application, the reviewing authority, and the level of scrutiny required.
Key Regulatory Authorities and Legal Framework
The current regulatory framework is governed by:
- Decree No. 98/2021/ND-CP (effective January 1, 2022)
- Decree No. 07/2023/ND-CP (issued March 3, 2023)
Together, these decrees streamline the registration system and establish clear responsibilities between local Departments of Health and the central Ministry of Health:
- Class A and B devices: Registration via notification process to the Department of Health (DOH)
- Class C and D devices: Registration via product application process to the Ministry of Health (MOH)
Importantly, once issued, registration numbers remain valid indefinitely, unlike past systems where renewals were required periodically.
Decree 07/2023 also extends the validity of existing import licenses until December 31, 2024, giving registrants more time to complete new registrations under Decree 98.
Registration Process by Device Class
- Type A & B Devices (Low-risk to low-moderate risk)
- Submit an online Declaration of Conformity via Vietnam’s Device Management Electronic Portal: https://dmec.moh.gov.vn
- The Department of Health will review the submission and, if satisfactory, publish the declaration number on the online portal.
- No pre-market approval is required, but post-market inspections apply to ensure ongoing compliance.
- Type C & D Devices (Moderate to high-risk)
- Submit a Product Registration Dossier to the Ministry of Health through the same portal.
- Upon receipt of a complete application and application fee, the MOH will respond within 30 days.
- If the application is incomplete, a request for modification will be issued within 25 days.
- Applicants have up to five chances to revise their submissions. If unsatisfactory after five attempts or not resubmitted within 90 days, the application is rejected.
- Post-market quality control applies to imported and marketed devices.
Required Documentation for Registration
To register a medical device in Vietnam, companies must prepare both legal and technical documents. Requirements vary by device class but generally include:
Legal Documents:
- Free Sale Certificate (FSC): Confirms the device is approved and sold in its country of origin.
- Letter of Authorization (LoA): Grants authority to the local representative to register the device.
- ISO 13485 Certificate: Demonstrates the manufacturer’s quality management system meets international standards.
Technical Documents:
- Classification Result: Confirms the device’s risk class under Vietnamese law.
- Technical Brief: Detailed description of the device’s design, function, and specifications.
- Instructions for Use (Vietnamese): Must be clearly translated for end users in Vietnam.
- Labeling and Packaging: Product labels should include manufacturer details, lot number, intended use, etc.
- Catalogue: General overview of the product’s features and intended application.
Additional Requirements:
- Clinical Trial Summary: Required for Class C and D devices that are invasive or implanted, summarizing safety and efficacy data.
- Measurement Instruments: Subject to approval and calibration by the Ministry of Science and Technology.
Properly organizing and submitting these documents is critical to ensuring the timely approval of a device.
Post-Market Obligations
Once devices are approved and marketed in Vietnam, registrants and importers must comply with post-market surveillance and inspection requirements, including:
- Product recalls and defect reporting
- Inspections by local health authorities
- Proper labeling and instruction updates
- Maintenance of records for traceability
The authorities may conduct random inspections or respond to complaints, so maintaining documentation and product quality is vital for ongoing compliance.
Strategic Considerations for Foreign Manufacturers
Given the evolving nature of Vietnam’s regulatory system and the high reliance on imports, foreign manufacturers should carefully weigh their market entry strategy. Here are some key recommendations:
- Use a Reputable Local Authorized Representative: Ensures regulatory compliance and minimizes registration delays.
- Centralize Documentation Management: Streamline your FSC, ISO, and clinical documents for reuse across multiple ASEAN markets.
- Plan Ahead for Class C and D Devices: Given the stricter MOH review, prepare complete and well-documented applications early.
- Monitor Regulatory Updates: Vietnamese laws and regulations have undergone multiple changes in recent years; ongoing tracking is essential.
Conclusion
Vietnam offers significant growth potential for global medical device manufacturers, but entering the market requires careful navigation of the country’s registration and compliance landscape. With a transparent classification system, digitized submission portal, and extended validity of registration numbers, Decree 98 and its amendments mark a major step toward regulatory efficiency.
Foreign manufacturers can succeed in this dynamic market by understanding the documentation and procedural requirements, choosing the right local partners, and staying current with evolving policies.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.