Vietnam Medical Device and IVD Classification and Grouping

What regulations inform Vietnam medical device classification?

Classification of medical devices and in vitro diagnostic (IVD) medical devices is regulated by the Infrastructure and Medical Device Administration (IMDA) under the framework of Decree No. 98/2021, which came into effect on January 1, 2022. This regulation aligns with international standards, including the ASEAN Medical Device Directive and Global Harmonization Task Force (GHTF) classification guidance. Circular 05/2022, as amended, provides additional guidance on the classification of medical devices and IVDs, as well as lists of device types that have specific market entry requirements or exemptions.

How are devices classified in Vietnam?

A medical device in Vietnam includes instruments, implants, materials, reagents, software, or in vitro calibrators that are used—alone or in combination—for human health purposes such as diagnosis, prevention, monitoring, treatment of disease or injury, supporting physiological functions, sustaining life, sterilization, or providing diagnostic information through specimen testing.

Vietnam classifies medical devices into four risk-based classes:

• Class A – Low risk; apply the rule to the actual product rather than assigning all gloves or instruments to this class

• Class B – Low-to-moderate risk; examples depend on the intended purpose and applicable rule

• Class C – Moderate-to-high risk (e.g., ventilators, anesthesia machines)

• Class D – High risk (e.g., pacemakers, defibrillators)

The classification depends on several factors including intended use, duration of contact with the body, invasiveness, whether it is active or passive (i.e., does the device require a power source, such as a battery), and whether it supports or sustains life.

IVD Medical Devices Classification

In vitro diagnostic (IVD) devices are defined in Decree 98/2021 as a subset of medical devices used to test specimens from the human body and include reagents, analyzers, calibrators, and related systems. IVDs are also classified under the same risk framework (Class A, B, C, and D), with classification based on intended use (e.g., self-testing vs. professional use); risk to public health (e.g., tests for transmissible agents); and impact on patient management.

Medical device and IVD grouping in Vietnam

Medical devices and IVDs can be grouped and registered as one application to obtain one medical device registration certificate. Medical devices that apply for registration as a group must have the same intended use, legal manufacturer, and risk classification. Potential grouping categories include single devices, families, systems, sets, IVD test kits, and IVD clusters.

2026 classification review and dossier consistency

Circular 24/2026/TT-BYT, effective 1 July 2026, confirms use of the A–D framework under Decree 98 for medical devices and amends the technical inspection timetable in Circular 05/2022. It does not replace device risk classes with a generic product-quality risk scale. The technical inspection duties for specified equipment are a separate assessment from product registration.

Prepare a rule-based rationale recording the intended medical purpose, users, patient population, technology and consequence of an incorrect result. For IVDs, identify analyte, specimen, diagnostic role and public-health risk. Document how the proposed grouping satisfies the relevant category; a shared brand or common distributor is insufficient.

Reconcile that record with the model list, Vietnamese labeling and evidence used for the declaration or registration route. The current Ministry portal should be checked for filing forms and current administrative instructions.

For regulatory terminology and the authority framework, see the Vietnam Ministry device authority.