Vietnam’s medical device market is expanding rapidly, making it an attractive destination for foreign manufacturers and investors. However, navigating the regulatory landscape requires a thorough understanding of the classification system, registration process, and compliance requirements. This guide provides a step-by-step approach to successfully registering medical devices in Vietnam while ensuring full regulatory compliance.

1. An Overview of Vietnam’s Medical Device Industry

Vietnam’s growing healthcare sector has increased demand for medical devices, attracting global manufacturers. To ensure product safety and efficacy, the Vietnamese government has established strict regulations under the Ministry of Health (MOH) and the Department of Medical Equipment and Construction (DMEC). The regulatory framework aligns with international standards, particularly the ASEAN Medical Device Directive (AMDD).

2. Medical Device Classification in Vietnam

Vietnam classifies medical devices based on risk levels, following the AMDD guidelines:

• Class A: Low risk (e.g., bandages, surgical gloves)
• Class B: Low to moderate risk (e.g., syringes, diagnostic ultrasound)
• Class C: Moderate to high risk (e.g., infusion pumps, ventilators)
• Class D: High risk (e.g., pacemakers, implantable medical devices)

Devices with multiple functions are classified based on their highest risk component. Higher-risk classes require more extensive documentation and regulatory scrutiny.

3. Essential Requirements for Medical Device Registration

To register a medical device in Vietnam, manufacturers must prepare the following documentation:

Legal Documents:

• Certificate of Free Sale (CFS): Confirms that the device is legally marketed in its country of origin.
• Letter of Authorization: Authorizes a local entity to act on behalf of the manufacturer.
• ISO 13485:2016 Certificate: Demonstrates compliance with medical device quality management systems.

Technical Documents:

• Classification Result: Official determination of the device’s class.
• Technical Brief: Detailed description of the device’s design, function, and intended use.
• Instructions for Use: Comprehensive guidelines on proper usage, translated into Vietnamese.
• Labeling Requirements: Compliance with Vietnamese regulations, including mandatory Vietnamese translations.
• Clinical Data Summary: Required for Class C and D devices, providing evidence of safety and performance.

4. Registration Pathways Based on Device Classification

The registration process varies depending on the classification:

Class A Devices:

• Submit a Declaration of Applied Standards to the local Department of Health.
• Once approved, the device can be legally marketed without requiring a Marketing Authorization Code (MAC).

Class B Devices:

• Also require a Declaration of Applied Standards, submitted to the local Department of Health.
• Once approved, the device can be marketed without a Marketing Authorization Code (MAC).

Class C and D Devices:

• Require submission of a Marketing Authorization Registration application to the MOH.
• As of January 1, 2024, dossiers must follow the ASEAN Common Submission Dossier Template (CSDT) format.
• Once approved, a Marketing Authorization Code (MAC) is issued.

5. Role of the Marketing Authorization Holder (MAH)

Foreign manufacturers must appoint a local entity as their Marketing Authorization Holder (MAH). The MAH serves as the official representative for regulatory submissions and compliance maintenance. This entity ensures adherence to Vietnamese laws, manages post-market surveillance, and handles updates related to the registered devices.

6. Labeling Regulations for Medical Devices

All medical devices sold in Vietnam must comply with strict labeling requirements, including:

• Product name and classification
• Manufacturer’s name and address
• Registration number or import license number
• Batch or serial number
• Expiry date (if applicable)
• Usage and storage instructions
• Warning labels (if required)
• Vietnamese translation (if the original label is in another language)

Failure to comply with labeling regulations can result in penalties or product recalls.

7. Validity of Registration and Importation

• Once granted, Marketing Authorization (MA) licenses do not expire, allowing indefinite validity for the registered device.
• Import licenses for Class C and D devices issued between 2018-2021 remain valid until December 31, 2024, under Decree 07/2023/ND-CP.

8. Import Regulations for Medical Devices

Only registered medical devices can be imported into Vietnam. Importers must meet the following requirements:

• Establishment License: Mandatory for companies involved in medical device distribution.
• Marketing Authorization Code (MAC): Required for Class C and D devices to obtain import approval.
• Import License (for Certain Devices): Required for some Class B, C, and D devices that involve complex technologies or high-risk applications.

9. Step-by-Step Medical Device Registration Process

To successfully register a medical device in Vietnam, follow these steps:

1. Classify the Device: Determine the correct classification based on risk level.
2. Prepare Required Documents: Gather ISO certifications, CFS, technical briefs, and labeling information.
3. Submit Registration Application: Applications for Class A and B devices go to the provincial Department of Health, while Class C and D devices are submitted to the DMEC.
4. Pay Registration Fees: Fees vary by classification:
   • Class A: ~VND 1,000,000 
   • Class B: ~VND 3,000,000 
   • Class C and D: ~VND 6,000,000 
5. Review and Approval: The review period ranges from 15 to 60 days, depending on classification.
6. Post-Registration Compliance: Maintain regulatory adherence, update documentation as required, and conduct post-market surveillance.

10. Benefits of Using a Professional Registration Service

Working with a professional registration service ensures:

• Faster approval times
• Full compliance with Vietnamese regulations
• Reduced risk of rejection or penalties
• Seamless importation and market entry

Conclusion

Navigating Vietnam’s medical device registration process requires careful planning, proper documentation, and strict regulatory adherence. By understanding classification rules, compliance requirements, and import regulations, businesses can efficiently enter Vietnam’s growing healthcare market. Partnering with an experienced regulatory consultant or Importer of Record (IOR) can streamline the process and ensure a successful market launch.

For professional assistance, Green NRJ is ready to guide you every step of the way and ensure a smooth market entry process.

📢 Let’s get your products registered in Vietnam today! Contact us for a free consultation.

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