Circular No. 46/2025/TT-BYT on the delegation of authority to decide standards and quotas for the use of specialized medical equipment under the jurisdiction of the Ministry of Health for agencies, organizations, and units under the management of the Ministry of Health.

CIRCULAR

Delegation of authority to decide standards and quotas for the use of specialized medical equipment under the jurisdiction of the Ministry of Health for agencies, organizations, and units under the management of the Ministry of Health

Pursuant to the Law on the Organization of the Government No. 63/2025/QH15 dated February 18, 2025;

Pursuant to the Law on Enacting Regulatory Legal Documents No. 64/2025/QH15 amended and supplemented by Law No. 87/2025/QH15;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on the management of medical devices amended and supplemented by Decree No. 07/2023/NĐ-CP, Decree No. 96/2023/NĐ-CP, and Decree No. 04/2025/NĐ-CP;

Pursuant to Decision No. 15/2025/QĐ-TTg dated June 14, 2025 of the Prime Minister stipulating standards and quotas for the use of machinery and equipment;

At the proposal of the Director of the Medical Infrastructure and Equipment Department;

The Minister of Health issues this Circular delegating the authority to decide standards and quotas for the use of specialized medical equipment under the jurisdiction of the Ministry of Health for agencies, organizations, and units under the management of the Ministry of Health.

Article 1. Scope of Regulation

This Circular stipulates the delegation of authority to decide standards and quotas for the use of specialized medical equipment under the jurisdiction of the Ministry of Health for agencies, organizations, and units under the management of the Ministry of Health.

Article 2. Delegation of authority to decide standards and quotas for the use of specialized medical equipment under the jurisdiction of the Ministry of Health for agencies, organizations, and units under the management of the Ministry of Health

The Minister of Health delegates authority to agencies, organizations, and units under the management of the Ministry of Health to decide standards and quotas for the use of specialized medical equipment of their own agency, organization, or unit according to the provisions at point b, Clause 2, Article 6 of Decision No. 15/2025/QĐ-TTg dated June 14, 2025 of the Prime Minister stipulating standards and quotas for the use of machinery and equipment.

Article 3. Implementation Provisions

1. This Circular takes effect from February 15, 2026.

2. In cases where the referenced documents in this Circular are replaced or amended, they shall be implemented according to the replacing or amending documents.

Article 4. Responsibilities for Implementation

1. The Medical Infrastructure and Equipment Department shall be responsible for:

a) Taking the lead and coordinating with relevant agencies, organizations, and units to guide and implement this Circular.

b) Monitoring, guiding, and inspecting the implementation of tasks and powers delegated.

2. Heads of agencies, organizations, and units under the management of the Ministry of Health shall be responsible for:

a) Deciding standards and quotas for the use of specialized medical equipment according to this Circular and Articles 2, 3, and 4 of Circular No. 08/2019/TT-BYT dated May 31, 2019 of the Minister of Health guiding standards and quotas for the use of specialized equipment in the field of health, ensuring effectiveness and suitability with the professional activities of their own unit; bearing full responsibility before the law and the Minister of Health regarding the results of the delegated tasks and powers.

b) Publicizing the decision on standards and quotas for the use of specialized medical equipment on the Ministry of Health's electronic portal.

Article 5. Transitional Provisions

Standards and quotas for the use of specialized medical equipment of agencies, organizations, and units that have been issued by competent authorities before the effective date of this Circular remain valid until replaced if they continue to be appropriate, according to the issued documents.

During implementation, if there are difficulties or obstacles, organizations and individuals should report them to the Ministry of Health (Medical Infrastructure and Equipment Department) for consideration and resolution.