Vietnam Sets IVD CSDT Assessment Criteria

The Ministry of Health of Vietnam has issued Decision No. 49/QD-BYT, promulgating the criteria and principles for assessing Common Submission Dossiers (CSDT) for in vitro diagnostic medical devices in accordance with ASEAN regulations.

The Decision establishes a standardized framework for the assessment of technical dossiers submitted for the registration and circulation of in vitro diagnostic medical devices in Vietnam. Its purpose is to support a consistent and transparent evaluation process while aligning Vietnam’s regulatory practices with the harmonized requirements of the ASEAN medical device regulatory framework.

The CSDT is a structured technical dossier designed to provide competent authorities with comprehensive information about a medical device. For in vitro diagnostic medical devices, the dossier generally includes information on the device’s intended use, design and manufacturing processes, essential principles of safety and performance, risk analysis, verification and validation, clinical or performance evaluation, labeling, and post-market surveillance.

The assessment criteria and principles under Decision No. 49/QD-BYT provide a basis for reviewing the completeness, consistency, and adequacy of the technical information submitted by applicants. They are intended to facilitate the evaluation of the safety, quality, and performance of in vitro diagnostic medical devices before they are placed on the Vietnamese market.

For manufacturers and international suppliers, compliance with the CSDT requirements is an important part of preparing a medical device marketing authorization application. A well-structured dossier can help applicants address regulatory requirements more effectively and support the review process conducted by the competent authorities.

Understanding Decision No. 49/QD-BYT is therefore essential for manufacturers, importers, distributors, and other stakeholders involved in the registration and commercialization of in vitro diagnostic medical devices in Vietnam.

Labomed Vietnam provides this legal reference to support international manufacturers and business partners in understanding Vietnam’s medical device regulatory framework and preparing for market access in the country.