Circular 59/2025/TT-BYT amending Circular 05/2022/TT-BYT detailing Decree 98/2021/ND-CP on management of medical equipment

 CIRCULAR

Amending and supplementing a number of articles of the Minister of Health’s Circular No. 05/2022/TT-BYT dated August 01, 2022, detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021, on management of medical equipment

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

Pursuant to the Government’s Decree No. 98/2021/ND-CP of November 08, 2021, on management of medical equipment, amended and supplemented under Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP;

At the proposal of the Director of the Agency for Health Infrastructure and Medical Equipment,

The Minister of Health hereby promulgates the Circular amending and supplementing a number of articles of the Minister of Health’s Circular No. 05/2022/TT-BYT dated August 01, 2022, detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021, on management of medical equipment.

Article 1. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 05/2022/TT-BYT dated August 01, 2022, detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021, on management of medical equipment

To amend Article 8 as follows:

“Article 8. Implementation roadmap

For medical equipment specified in Clauses 1, 2, 3, 4, 5 and 6, Article 5 of this Circular:

1. Medical equipment purchased after June 30, 226, must be subject to safe and technical inspection in accordance with the inspection procedures promulgated by the Minister of Health;

2. Medical equipment purchased before July 01, 226, shall continue to be used and must completely undergone safe and technical inspection before December 31, 2026, in accordance with the inspection procedures promulgated by the Minister of Health. Health establishments shall bear full legal responsibility for ensuring patient safety when using such medical equipment during the period in which inspection has not yet been carried out.”.

Article 2. Effect

This Circular takes effect from the date of its signing for promulgation.

Article 3. Implementation organization

1. The Agency for Health Infrastructure and Medical Equipment shall:

a) Assume the prime responsibility for, and coordinate with relevant agencies and units in, implementing this Circular;

b) Disseminate information and encourage the further development of medical equipment inspection establishments in accordance with regulations;

c) Strengthen inspection, supervision, and urge the implementation of medical equipment inspection at inspection establishments and health establishments.

2. Heads of health establishments shall:

a) Carry out the inspection of medical equipment in strict accordance with regulations;

b) Manage, maintain, service, and use medical equipment in compliance with the manufacturer’s instructions;

c) Carry out regular inspection and assessment of quality and report medical equipment that fail to meet quality requirements to the competent management agency in accordance with regulations.

Any difficulties arising in the course of implementation shall be reported to the Ministry of Health (the Agency for Health Infrastructure and Medical Equipment) for consideration and settlement./.