Completing the legal framework for medical equipment management
The Vietnamese market currently has nearly 300,000 items of medical equipment, about 92% of which are imported goods; with high-tech equipment, the level of dependence on foreign goods is almost complete.
According to the Ministry of Health, data on import, distribution, prices, procurement and use are still scattered, not fully standardized and interconnected, causing difficulties for traceability, identification of distributors, warnings and recalls in case of incidents.
Implementing the requirements of the Government and the Prime Minister, the Ministry of Health is developing contents to amend and supplement Article 113 of the Law on Medical Examination and Treatment, including it in the draft Law amending and supplementing a number of laws in the field of health, expected to be submitted to the National Assembly at the 2nd Session, 16th National Assembly.
The amendment aims to improve the legal framework for medical equipment management, in the context that many specialized contents are currently mainly regulated at the decree level.
The draft aims to manage quality, data, usage, prices and supply chains; increase transparency, reduce unnecessary intermediaries and contribute to ensuring access to quality equipment at reasonable costs.
Draft Article 113 updated on September 10, 2026 includes 4 clauses, focusing on: equipment management according to life cycle and risk level; management and use at medical facilities; prices, procurement, import; detailed regulatory authority of the Government and the Minister of Health.
No new decentralization or hierarchy
According to the Ministry of Health, the draft does not decentralize or decentralize state management tasks for medical equipment from the Central level to the local level or between local government levels.
The draft assigns the Government to detail and decide on the roadmap and management measures in some cases; the Minister of Health promulgates a list and content of information that must be publicized online, the roadmap and rules for classifying equipment according to risk levels.
Medical equipment management shifts strongly to data-based
The draft requires that the medical equipment database must ensure "correct, sufficient, clean, live, unified, shared and shared". Information on listed prices and business establishments is oriented towards publicity and transparency; The Minister of Health shall identify the list, content of public information and implementation roadmap.
Management according to the life cycle and risk level creates a basis for applying technology to traceability, warning, quality monitoring and post-inspection.
Accordingly, medical equipment management can shift from relying heavily on individual records and procedures to management using data throughout the life cycle.
Registration, import, distribution, price, procurement and usage data can be standardized, connected, supported for retrieval, warning, recall and quality monitoring; medical facilities also have additional tools for searching and comparing information.
The Ministry of Health orients to inherit and upgrade existing systems and reuse data according to the principle of "importing once, using many times", avoiding duplicate investment and limiting businesses from having to re-declare existing information.
To overcome the current limitations, the Ministry of Health proposes to manage medical equipment according to the life cycle, from registration, import, distribution to use, warranty, maintenance and recall on a unified database platform.
Regarding prices, the orientation is to increase publicity, transparency and post-inspection instead of the State approving the prices of each device. Businesses self-determine, announce maximum selling prices and be responsible for information; management agencies strengthen data exploitation, monitoring and warning.
The Ministry of Health also proposed reducing unnecessary intermediate layers, encouraging manufacturers to distribute directly and allowing medical facilities to purchase and import directly when meeting the conditions.
The goal is market transparency, reducing intermediary costs, increasing traceability and ensuring that medical equipment is managed throughout its life cycle.
An Giang Department of Health contributed opinions: This mechanism helps hospitals access sources of original prices from foreign manufacturers. It is proposed that the Government clearly stipulate the minimum conditions on techniques, personnel and foreign trade legal affairs for medical facilities to be purchased and imported directly; and at the same time simplify customs procedures and registration for circulation so that hospitals, especially at the local level, can feel secure in implementing and ensuring legal safety.
The Ministry of Health replied: The draft does not apply the mass purchase and direct import rights, but assigns the Government to stipulate the roadmap and conditions. The conditions will include technical capacity, personnel, contracts, payments, customs, logistics, installation, warranty, maintenance and post-circulation responsibilities. Direct import is only carried out when the company has a legal focal point in Vietnam, and at the same time the procedures are simplified within the scope of law, not contrary to regulations on bidding, customs and foreign trade.
Bac Ninh Department of Health contributed opinions: It is proposed to review and clarify the responsibilities of organizations and individuals trading in medical equipment, owners of circulation numbers, importers, and distributors in ensuring quality, traceability, and handling of medical equipment incidents.
The Ministry of Health replied: Accepting the request to clarify the responsibilities of entities in the supply chain. The draft stipulates the principles of management according to the life cycle, supply chain, data and transparency, and at the same time assigns the Government to specify details. The responsibilities of the owner of the circulating number, manufacturer, importer and distributor regarding quality, traceability, warning, and incident handling will be specified in the Decree, ensuring fullness but not making Article 113 too detailed.
