Vietnam Proposes Lifecycle Management for Medical Devices, Building Data Infrastructure

Vietnam's Ministry of Health has proposed a new policy to manage medical devices throughout their entire lifecycle, including building a connected data infrastructure, enhancing oversight of the distribution chain, and reducing unnecessary intermediaries. The proposal is part of an impact assessment report for amending Article 113 of the Law on Examination and Treatment, currently under review by the Ministry of Justice. The Ministry of Health states that Vietnam's medical device market is vast, with diverse product types and technologies, ranging from consumables to diagnostic and treatment machines, laboratory equipment, surgical robots, and medical software. Many devices have long lifecycles, involving warranty, maintenance, calibration, and software updates. Therefore, management cannot be confined to the point of registration or procurement but must encompass the entire process from manufacturing, import, distribution, use, to post-circulation disposal. Currently, approximately 295,000 items are distributed in the market, with 92% being imported products. High-technology devices are almost entirely dependent on foreign supply. The market is fragmented by model, configuration, and product group, complicating price management, traceability, and post-inspection. An online public service system for medical devices has been operational since 2020, with a goal to provide 100% of public services in this sector fully online by 2026. However, current data primarily serves registration, declaration, and licensing. Information on imports, distribution, pricing, procurement, and usage is not yet sufficiently standardized and interconnected for search, alert, and post-inspection purposes. When safety alerts or recalls occur, quickly identifying the product, the entity that brought it to market, the official distribution channel, and the facility currently using it remains challenging. The Ministry of Health believes that while current laws adequately regulate many management stages, a principle of lifecycle management based on interconnected data has not yet been established. Consequently, the Ministry of Health proposes lifecycle management for medical devices on a data platform. A unified, interconnected, and shared medical device database will be built, prioritizing the reuse of existing data. Information about business establishments, official distributors, or agents will also be considered for public disclosure within appropriate scopes and timelines. The objective is to enhance traceability, alerting, recall, warranty, maintenance, and quality control during use. Furthermore, the Ministry of Health proposes a focused approach to price management. Businesses will be responsible for their declared prices, while regulatory bodies will concentrate on data, monitoring, and post-inspection. Price negotiation and centralized procurement will continue to be used for suitable device groups, rather than being applied universally. Additionally, the reduction of unnecessary intermediaries is proposed. The Ministry of Health suggests encouraging manufacturers to distribute directly, while also allowing direct purchase and import in cases meeting specific conditions. Distributors will be maintained if they provide essential services such as warranty, maintenance, technical support, and after-sales supply. The Ministry of Health indicates that the general direction is a shift from procedure-heavy management to data- and responsibility-based management. Products will be tracked throughout their entire lifecycle, businesses will bear greater responsibility for information and pricing, and regulatory agencies will focus on monitoring, alerting, and post-inspection.