Vietnam Issues Guidance on the Review of Legal Documents for Medical Device Marketing Authorization Applications

On August 5, 2024, Vietnam’s Ministry of Health issued Decision No. 2302/QD-BYT, promulgating guidance on the review of legal documents included in medical device marketing authorization applications. The Decision aims to provide a consistent basis for assessing the legal validity and completeness of application dossiers submitted for the circulation of medical devices in Vietnam. It took effect on the date of issuance and replaced Decision No. 3007/QD-BYT dated November 3, 2022.

The guidance is developed under the regulatory framework established by Decree No. 98/2021/ND-CP on the Management of Medical Devices, as amended and supplemented by relevant legal instruments, including Decree No. 07/2023/ND-CP. It specifies the legal documents subject to review by legal assessors during the evaluation of medical device marketing authorization applications.

Key documents covered by the guidance include the application for issuance of a marketing authorization number, a valid ISO 13485 certificate, and a valid letter of authorization issued by the medical device owner to the entity responsible for submitting the application. Depending on the nature of the device and the applicable regulatory pathway, additional documents may be required, such as a certificate of conformity, a valid type-approval decision for measuring instruments, or circulation documents issued by reference countries in cases eligible for expedited processing.

For in vitro diagnostic medical devices, the guidance also addresses requirements concerning quality assessment certificates issued by competent Vietnamese authorities or designated organizations, subject to specific exemptions under applicable regulations.

The Decision includes an appendix setting out detailed assessment criteria for legal documents, supporting a more structured and consistent review process.

For manufacturers, importers, distributors, and international medical device companies seeking market access in Vietnam, understanding Decision No. 2302/QD-BYT is essential for preparing complete documentation and facilitating regulatory compliance. Labomed Vietnam provides this legal reference to support partners in navigating Vietnam’s medical device registration requirements.