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.
• Decree No. 04/2025/NĐ-CP, effective January 1, 2025, further amends Decree 98/2021 (as revised by Decree 07/2023), particularly in relation to import procedures, transitional arrangements, and certain management requirements applicable to medical devices.

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 other simple non-invasive accessories.

• 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. Each component of an in vitro diagnostic (IVD) system, such as instruments, reagents, calibrators, and control materials may be classified individually. However, when the system is intended to function as an integrated diagnostic unit, the final risk classification must correspond to the highest risk level applicable to the system as a whole.

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?

Under Article 5 and Article 74 of Decree No. 98/2021/NĐ-CP (as amended by Decree No. 07/2023/NĐ-CP), the classification of medical devices in Vietnam is the responsibility of the organization that declares applicable standards or registers the circulation number for the device. In all cases, the registration holder is deemed the ‘classification establishment’ under Vietnamese law and is legally accountable for the accuracy of the classification uploaded to the MOH portal.

This means that the entity listed as the applicant or registration holder,  typically the manufacturer, importer, or authorized representative, must perform the classification in accordance with the official risk-based rules issued by the Ministry of Health (MOH).

Enterprises may carry out the classification themselves if they have the necessary technical capability, or they may hire a qualified third party to assist.
However, the registration holder remains legally responsible for the accuracy and validity of the classification result published on the MOH online portal.

If the MOH later determines that a classification result understated the device’s actual risk level or was conducted beyond the registrant’s authority, it may order corrective actions or revoke the related registration number (per Article 74 of Decree 98/2021/NĐ-CP).

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 compile the Classification Result Table, which forms part of the declaration of applied standards or the registration dossier. Classification is not a separate approval procedure for a medical device. The required documents generally include:

• 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.

The registration holder must maintain this dossier to justify the classification result they have published on the MOH portal.

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 registration holder (as the classification establishment) to carry out corrective measures, remove the revoked classification from the MOH’s electronic management portal, and is disseminated to the registration holder, relevant provincial health departments, the General Department of Customs, and customs authorities at border checkpoints.

Subsequently, The registration holder must cease using the revoked classification result in any pending or future dossiers and must rectify affected registrations or import procedures accordingly. 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, guide your team in fulfilling your classification responsibilities, and streamline your import process.

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