Vietnam Consolidates Medical Device Management Regulations
On March 16, 2020, Vietnam’s Ministry of Health issued Integrated Document No. 01/VBHN-BYT, consolidating the Government’s regulations on the management of medical devices. The document integrated Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, and Decree No. 03/2020/ND-CP, creating a consolidated reference text for the regulatory framework applicable at that time.
The consolidated regulations covered a broad range of activities relating to medical devices, including classification, manufacturing, circulation, trading, provision of medical device services, information and labeling, and the management and use of medical devices at healthcare facilities.
A key element of the framework was the definition and risk-based management of medical devices. The regulations covered products such as equipment, instruments, materials, implantable devices, in vitro reagents and calibrators, and software that met the prescribed criteria and were intended for purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease and injury.
The document also provided regulatory requirements concerning the classification of medical devices, eligibility for manufacturing and trading, circulation, import and export, labeling, and the responsibilities of organizations and individuals involved in the medical device sector. These requirements established an important foundation for managing medical devices throughout their lifecycle and ensuring their safety and quality.
For manufacturers, importers, distributors, and healthcare organizations, the consolidated document served as a useful reference for understanding Vietnam’s medical device regulatory requirements before the subsequent regulatory framework under Decree No. 98/2021/ND-CP was introduced.
Integrated Document No. 01/VBHN-BYT is no longer in force. However, it remains a useful historical reference for understanding the development of Vietnam’s medical device regulatory framework and the regulatory basis that preceded Decree No. 98/2021/ND-CP.
Labomed Vietnam provides this regulatory reference as part of its collection of legal documents relevant to Vietnam’s medical device market, supporting manufacturers, suppliers, distributors, and international partners in understanding the evolution of medical device regulations in the country.
Loading Viewer...
