Vietnam medical device classification is a critical step for market entry. What makes it so important? How do regulators decide whether a product belongs to Class A, B, C, or D? And what determines the level of risk that guides this process?

For manufacturers and distributors, these questions are more than theory—they directly affect how quickly a product can enter the market and the type of procedures required. In this article, Green NRJ will uncover the principles behind Vietnam’s risk-based classification system, clarify how different device categories are defined, and outline the procedural steps every company must follow to comply with local requirements. By understanding the essentials of classification, you can minimize compliance risks, avoid unnecessary delays, and ensure smoother access to Vietnam’s growing healthcare market.

1. Regulatory Framework – Key Legal Documents

• Decree No. 98/2021/NĐ-CP, issued on November 8, 2021, effective January 1, 2022, regulates the management of medical devices in Vietnam, including classification, manufacturing, marketing, import/export, pricing and post-market surveillance.

• Decree No. 07/2023/ND-CP (issued March 3, 2023) — amends and supplements Decree 98/2021, extending the validity of import licenses, adjusting transitional provisions, and clarifying registration procedures.

• Circular No. 05/2022/TT-BYT, issued by the Ministry of Health on August 1, 2022, fleshes out detailed guidelines for implementing provisions of Decree 98/2021, including device classification criteria, lists of IVDs exempt from quality assessment, which devices can be traded as normal goods, those requiring safety inspection, and those needing import licensing.

2. Vietnam Medical Device Classification System (A, B, C, D) and Key Principles

2.1 Classification Levels

Vietnam categorizes medical devices into four risk-based classes according to Article 4, Decree 98/2021:

• Class A – Low risk
  Devices in this group are simple, non-invasive, and pose minimal potential harm. Examples include bandages, examination gloves, stethoscopes, and surgical forceps.

• Class B – Low–moderate risk
  This class covers devices with a slightly higher level of risk, often involving limited invasiveness or temporary contact with the human body. Examples include hypodermic needles, infusion sets, suction equipment, and diagnostic ultrasound devices.

• Class C – Moderate–high risk
  Devices in Class C may sustain or support life, are invasive for longer durations, or present significant risks if they malfunction. Examples include ventilators, orthopedic bone fixation systems, dialysis machines, and certain diagnostic imaging equipment.

• Class D – High risk
  The highest classification, Class D covers devices that are critical to sustaining life, implanted long-term, or that pose the greatest potential for harm. Examples include heart valves, implantable pacemakers, implantable defibrillators, and advanced blood screening IVDs.

2.2 Classification Principles

The rules for assigning devices to these classes are clearly defined in Article 5 of Decree No. 98/2021/ND-CP, with detailed guidance provided in Appendix I of Circular No. 05/2022/TT-BYT

1. If a device has a single intended use but could fall into multiple risk levels, it must be classified in the highest applicable class.

2. When a device has multiple intended uses, possibly spanning different levels of risk, it similarly must be classified in the highest risk class.

3. For combination devices (i.e., those designed to be used with other devices), each component must be classified individually, according to its own risk profile.

4. In vitro diagnostic (IVD) systems—including instruments, reagents, calibrators, or control materials—are each classified separately, but the final classification reflects the highest risk posed by any component to the end-use of the system.

5. Classification rules are aligned with the ASEAN Medical Device Directive (AMDD), reflecting Vietnam’s commitments as an ASEAN member state

6. Only the declaring or registering entity—as identified in the Declaration of Applied Standards or in the Registration Certificate—is authorized and legally responsible for determining the device’s classification

3. Procedural Steps and Responsibilities

3.1 Documentation and Procedures

• Use Annex I of Circular 05/2022/TT-BYT to determine risk class

• Prepare a classification dossier, including:

  • Application form

  • Product catalogue, technical documents

  • User manual and labeling

  • Applicable standards and quality certificates (e.g., ISO 13485)

• Submit according to classification:

  • Class A → Declaration of applied standards

  • Class B, C, D → Apply for registration number (or import license if applicable).

3.2 Templates and Official Forms

• Annex II of Circular 05/2022/TT-BYT provides the official template for the classification result form

• Circular 19/2021/TT-BYT provided general templates for reports and classification documents under earlier regulations. Some of these forms have since been updated and replaced by Circular 10/2023/TT-BYT

4. Summary Table

5. Conclusion

“Correctly classifying your medical device under Class A, B, C, or D according to Decree 98/2021 and Circular 05/2022 is essential for regulatory compliance in Vietnam. The risk-based classification determines whether you follow a declaration or registration pathway. At Green NRJ, we specialise in guiding companies through Vietnam’s regulatory landscape—accurate classification, dossier preparation, and registration. Contact Green NRJ today to ensure your device meets all legal requirements and achieves efficient market access in Vietnam.”