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June 16, 2025
Approximately 5 minutes
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
The classification of a medical device is the foundational first step for regulatory compliance in Vietnam, determining the subsequent regulatory pathway (Notification vs. MA License) and the required documentation. Vietnam’s classification system aligns closely with the international Global Harmonization Task Force (GHTF) guidelines.
The Four Risk Classes
Medical devices in Vietnam are categorized into four classes, ranging from the lowest to the highest risk, based on factors such as intended use, level of risk to the patient, delivery method, and degree of invasiveness.
- Class A: Low Risk
- Class B: Medium-Low Risk
- Class C: Medium-High Risk
- Class D: High Risk
Classification guidance is primarily found in Circular 05/2022 (which replaced Circular 39/2016).
Responsibility Shift to the Registration Holder
Under previous Vietnamese regulations, device risk classification had to be performed by a locally certified third-party organization or person. Decree 98/2021/ND-CP implemented a significant change to streamline this process:
- New Rule: The responsibility for classifying the product now falls directly to the Registration Holder (the local authorized representative) as part of the overall application submission process.
- Impact: This shift allows manufacturers and their local agents greater control over the initial classification, though it must still strictly adhere to the guidelines set out in the relevant Circulars.
IVD Classification
In Vitro Diagnostic (IVD) devices are also classified into the same four categories (A through D). The classification rules for IVDs are based on 7 specific rules outlined in the regulatory appendices and closely follow the guidance provided by the ASEAN Medical Device Directive (MDD).
Factors that specifically affect the risk classification of IVDs include:
- Purpose of use and intended indications.
- Expertise of the medical device user.
- Importance and impact of the device information on individuals and public health.
Accurate classification is mandatory for market entry, as it dictates the level of regulatory scrutiny and the specific documentation required for obtaining the Market Authorization (MA) License.
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