Master Vietnam Medical Device Classification A–D Procedure Guide 2025

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

Who Can Perform the Classification?

According to Decree No. 98/2021/ND-CP on Medical Device Management, the classification of medical devices in Vietnam must be carried out by qualified classification organizations recognized and published by the Ministry of Health (MOH). The MOH is responsible for updating and disclosing the official list of such organizations.

Only classification results issued by these recognized organizations are considered legally valid and serve as the official basis for:

• Medical device registration (granting of registration numbers), and

• Import licensing procedures, where applicable.

This means that enterprises, importers, or distributors cannot self-classify their devices. They must engage a MOH-recognized classification organization, whose name must be indicated in the registration dossier.

Required Documents for Classification Submission

Under Decree No. 98/2021/ND-CP on Medical Device Management and its implementing guidelines, an importer or distributor must prepare a complete dossier to obtain an official classification result for a medical device. The required documents generally include:

• Application letter formally requesting classification.

• Technical documents such as catalogues and product specifications.

• Instructions for Use (IFU) provided by the manufacturer.

• Declared standards that the manufacturer applies to the device.

• Supporting certificates, which may include a Certificate of Free Sale (CFS), ISO certificates, or a Letter of Authorization (LOA), depending on the device type and risk class.

Only dossiers containing sufficient and valid documents will be accepted by a MOH-recognized classification organization, and the issued classification result will serve as the legal basis for subsequent registration.

Revocation of Classification Results

Under Article 6 of Decree 98/2021/ND-CP, the Ministry of Health (MOH) has the authority to revoke a medical device classification result in cases where:

• The classification is incorrect and understates the actual risk level of the device; or

• The classification documents are found to be forged.

Once such a determination is made, MOH must, within one working day, issue an official decision to revoke the classification. The decision requires the classification body to carry out corrective measures, remove the revoked classification from the MOH’s electronic management portal, and is disseminated to the classification body, relevant provincial health departments, the General Department of Customs, and customs authorities at border checkpoints.

Subsequently, the classification body must withdraw all affected classification certificates. Authorities reviewing registration applications or managing issuance of registration numbers must then review and revoke any registration numbers granted based on the revoked classification. In practice, importers using such revoked classifications must reapply for correct classification before they can resume registration or import procedures.

Conclusion

Medical device classification in Vietnam is the first and most crucial step for foreign manufacturers and local importers. With strict MOH oversight, ensuring accurate classification can save months of delays and prevent compliance risks.

At Green NRJ, we specialize in assisting international companies with medical device classification and registration in Vietnam. Our regulatory experts help you prepare the right documents, work with authorized classification organizations, and streamline your import process.

📩 Contact Green NRJ today to ensure your medical devices are correctly classified and compliant with Vietnam’s regulations.