Regulatory Affairs Update: Vietnam

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

In the first quarter of 2024, The Department of Infrastructure and Medical Equipment released Decision No. 166/QĐ-BYT and Decision No. 490 / QĐ-BYT regarding the issuance of criteria and principles for assessment of the general technical documentation for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT).

They have provided the principles for evaluating CSDT documentation as follows:

In-Vitro Medical devicesNon-In Vitro Medical devices
1.The General summary document on medical devices
1.1Brief, general description of medical devicesXX
1.2History of circulation on the marketXX
1.3Intended use and indication for useXX
1.4Licensing information for circulation in different countriesXX
1.5The importance of information relating to the safety and effectiveness of medical devices.XX
2. Essential Principles ChecklistXX
3. The documents describe medical devices
3.1Describe and display the features of medical devicesXX
3.2Intended to useX
3.3Indication for youX
3.4User manualXX
3.5User manualX
In-Vitro Medical DevicesNon-In Vitro Medical Devices
3.8Potential adverse effectsXX
3.9Alternative treatmentsXX
3.11Other relevant technical specificationsXX
3.12Other informationXX
4. Summary document on design verification and validation
4.1Pre-Clinical research
4.1.1. Verification and validation studies of the softwareXX
4.1.2 Medical devices containing biological materialsXX
4.2Preclinical studies of reagents, calibrators, and in-vitro control materials
4.2.1 Analytical PerformanceX
4.2.2 StabilityX
4.3Clinical Evidence
4.3.1 Data from available reference documentsXX
4.3.2 Data from Clinical ExperienceXX
4.3.3 Data from clinical studiesXX
5. Labelling of Medical devices
5.1Labeling on the medical devices and packagingXX
5.2Vietnamese user manual.XX
6. Risk AnalysisXX
7. The production information
7.1Information on manufacturing sitesXX
7.2The production processXX

In addition, this Decision also provided Annex 2 for the Essential Principles Checklist for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT).  In the case of medical devices that have been granted market authorization in EU member states, the Essential Requirements Checklist according to EU Regulations may be used if available.

The assessment report of ASEAN’s CSDT of Non-In Vitro and In-Vitro Medical Devices in Annex 3 is attached in the decision. Please refer to the link for the detailed information in Vietnamese:



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