Master Vietnam Medical Device Classification A–D Procedure Guide 2026

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.

Understanding the Risk-Based Classification of Medical Devices (Class A, B, C, D)

The essence of the classification lies not in the device’s name, but in the level of risk it poses to the user.

According to Article 4 of Decree No. 98/2021/ND-CP, medical devices are divided into four groups of increasing risk:

Class A devices generally have the lowest risk, primarily being non-invasive products with minimal health impact. As the level of intervention increases or invasiveness increases, devices are categorised into classes B or C. Meanwhile, class D represents the highest-risk devices, often involving long-term implantation or life support.

It’s crucial that classification isn’t solely based on structure, but also depends on the intended use, duration of contact with the body, and the device’s operating mechanism. This is why the same product can result in different classifications depending on its application context.

Classification Principle: Why Always Choose the Highest Risk Level

One of the core principles in the classification of medical devices in Vietnam is to always choose the highest risk level in all possible scenarios. If a device has multiple uses, the classification will be based on the use with the highest risk. Similarly, with combined systems or devices, each component may be assessed separately, but the final result must still reflect the highest risk level of the entire system. This principle helps regulatory agencies closely control potential risks while placing higher demands on businesses to accurately assess products from the outset.

Legal Responsibility in Product Classification

It is not the regulatory agency, but the business that publishes or registers the product for circulation that is directly responsible for the classification results. The business can perform the classification itself or hire a consulting firm, but legally, the responsibility remains unchanged. If the classification results are inaccurate, the business may face requirements for correction, recall of the product registration number, or even suspension of product circulation on the market. This requires the business not only to understand the regulations but also to have the technical assessment capabilities or to choose a consulting partner with sufficient expertise.

Classification Documentation: Proper Preparation to Avoid Delays

In reality, classification is not a standalone procedure but an integral part of the declaration or marketing authorization dossier. To build the classification report, businesses need to rely on technical documents such as catalogs, instruction manuals (IFUs), descriptions of intended use, operating principles, and the degree of invasiveness of the device. This information forms the basis for comparison with classification rules and determining the appropriate risk level. Although some documents such as Certificate of Free Sale or ISO 13485 are not mandatory for the classification step, early preparation will significantly shorten the overall dossier completion time.

When are classification results revoked and what are the consequences?

Incorrect classification doesn’t just stop at adjusting the documentation; it can lead to serious consequences. If the results don’t accurately reflect the risk level or show signs of dishonesty, the Ministry of Health has the right to revoke the classification results and request their removal from the system. This can lead to customs clearance suspension, withdrawal of registration numbers, or even recall of products already distributed in the market. Businesses are then forced to repeat the entire classification process and cooperate with relevant agencies to address the resulting consequences.

Conclusion: Proper classification from the start optimizes the entire process.

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.