Vietnam Adopts Non-IVD CSDT Assessment Criteria

On January 22, 2024, Vietnam’s Ministry of Health issued Decision No. 166/QD-BYT, promulgating the criteria and principles for assessing the ASEAN Common Submission Dossier Template (CSDT) for medical devices other than in vitro diagnostic (IVD) medical devices. The Decision took effect from the date of signing and provides an important reference for the technical assessment of medical devices seeking marketing authorization in Vietnam.

The Decision was issued pursuant to Vietnam’s regulatory framework on medical device management, including Decree No. 98/2021/ND-CP, as amended and supplemented by Decree No. 07/2023/ND-CP, as well as relevant regulations governing medical device documentation and the preparation of ASEAN CSDT dossiers.

The CSDT framework establishes a standardized structure for presenting technical information to support the assessment of medical devices. Under Decision No. 166/QD-BYT, the assessment criteria and principles are provided in three appendices, covering key technical and regulatory aspects of non-IVD medical devices.

The assessment process focuses on essential information necessary to evaluate a device’s safety, quality, and performance. Depending on the type and risk classification of the device, the technical dossier may include an executive summary, device description, information on design and manufacturing, essential principles checklist, risk analysis, verification and validation data, clinical evidence, labeling, and other supporting documentation.

For manufacturers and international suppliers, preparing a complete and well-structured CSDT dossier is an important step in meeting Vietnam’s medical device registration requirements. The criteria set out in the Decision provide a practical reference for organizing technical documentation and facilitating the review process by competent authorities.

Labomed Vietnam provides this regulatory reference to support medical device manufacturers, importers, distributors, and international partners in understanding Vietnam’s technical documentation requirements and preparing for market access in the country.