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 devices | Non-In Vitro Medical devices | ||
|---|---|---|---|
| 1.The General summary document on medical devices | |||
| 1.1 | Brief, general description of medical devices | X | X |
| 1.2 | History of circulation on the market | X | X |
| 1.3 | Intended use and indication for use | X | X |
| 1.4 | Licensing information for circulation in different countries | X | X |
| 1.5 | The importance of information relating to the safety and effectiveness of medical devices. | X | X |
| 2. Essential Principles Checklist | X | X | |
| 3. The documents describe medical devices | |||
| 3.1 | Describe and display the features of medical devices | X | X |
| 3.2 | Intended to use | X | |
| 3.3 | Indication for you | X | |
| 3.4 | User manual | X | X |
| 3.5 | User manual | X | |
| 3.6 | Warning | X | X |
| 3.7 | Cautions | X | X |
| In-Vitro Medical Devices | Non-In Vitro Medical Devices | ||
| 3.8 | Potential adverse effects | X | X |
| 3.9 | Alternative treatments | X | X |
| 3.10 | Materials | X | X |
| 3.11 | Other relevant technical specifications | X | X |
| 3.12 | Other information | X | X |
| 4. Summary document on design verification and validation | |||
| 4.1 | Pre-Clinical research | ||
| 4.1.1. Verification and validation studies of the software | X | X | |
| 4.1.2 Medical devices containing biological materials | X | X | |
| 4.2 | Preclinical studies of reagents, calibrators, and in-vitro control materials | ||
| 4.2.1 Analytical Performance | X | ||
| 4.2.2 Stability | X | ||
| 4.3 | Clinical Evidence | ||
| 4.3.1 Data from available reference documents | X | X | |
| 4.3.2 Data from Clinical Experience | X | X | |
| 4.3.3 Data from clinical studies | X | X | |
| 5. Labelling of Medical devices | |||
| 5.1 | Labeling on the medical devices and packaging | X | X |
| 5.2 | Vietnamese user manual. | X | X |
| 6. Risk Analysis | X | X | |
| 7. The production information | |||
| 7.1 | Information on manufacturing sites | X | X |
| 7.2 | The production process | X | X |
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:
490qdb_QD-huong-dan-ho-so-csdt-ivd.signed
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