05 amended administrative procedures in the field of medical equipment in Vietnam according to Decision 1705/QD-BYT

On June 18, 2024, Ministry of Health of Vietnam issued Decision 1705/QD-BYT including a list of 05 administrative procedures in the field of medical equipment that were amended and supplemented according to Decree 96/2023/ND-CP, detailing several articles of the Law on Medical Examination and Treatment under the functional management scope of the Ministry of Health.

1. 05 amended central-level administrative procedures in the field of medical equipment in Vietnam according to Decision 1705/QD-BYT

Decision 1705/QD-BYT has supplemented 05 administrative procedures amended in the field of medical equipment including:

- Issuance of a new circulation number for medical equipment of type C and D with corresponding national technical standards;

- Issuance of a new circulation number for medical equipment of type C and D that are measuring instruments requiring model approval according to measurement laws;

- Issuance of a new circulation number for certain expedited medical equipment of type C and D;

- Emergency issuance of circulation numbers for medical equipment of type C and D in urgent situations to serve disease prevention and control;

- Issuance of a new circulation number for other medical equipment of type C and D.

2. Which agency is responsible for implementing administrative procedures in the field of medical equipment in Vietnam?

Based on Clause 2, Article 2 of Decision 5074/QD-BYT in 2019, the agencies responsible for implementing administrative procedures include:

a) The Ministry of Health, the Department of Medical Equipment and Construction, and units under the Ministry of Health;

b) Departments of Health of provinces and cities;

c) The General Department of Customs and the Customs Departments under the General Department of Customs.

Additionally, according to Clause 1, Article 1 of Decision 5074/QD-BYT, 04 administrative procedures in the field of medical equipment that apply the national single-window mechanism are:

- Declaration of applied standards for medical equipment of type A;

- Issuance of a new circulation number for medical equipment without corresponding national technical standards;

- Extension of the circulation number of medical equipment;

- Issuance of free sale certificates for medical equipment with a circulation number.

3. Principle of management and use of medical equipment in medical examination and treatment facilities in Vietnam

According to Article 105 of Decree 96/2023/ND-CP detailing several articles of the Law on Medical Examination and Treatment under the functional management of the Ministry of Health, medical equipment in medical examination and treatment facilities must comply with the following principles:

(1) Must be allowed to circulate, trade, and receive according to laws about the management of medical equipment and related laws;

(2) Must ensure compliance with regulations on the management and use of medical equipment according to laws about the management of medical equipment and related laws;

(3) There is an obligation to ensure funding to serve the maintenance, repair, inspection, calibration of medical equipment, and training, updating knowledge for staff using medical equipment in the facility according to laws;

(4) Must assign departments and personnel responsible for managing the use, inspection, maintenance, repair, inspection, calibration of medical equipment;

(5) Personnel stipulated in Clause 4, Article 105 of Decree 96/2023/ND-CP must have certificates of training, updating knowledge on the management of medical equipment as regulated by the Ministry of Health.

Additionally, for the management, use, inspection, maintenance, repair, replacement of materials and components, inspection, calibration of medical equipment, medical examination, and treatment facilities must:

(1) Must have a management and tracking file on: the list; usage; inspection; maintenance; repair; component replacement; inspection, calibration;

(2) The head of the medical examination and treatment facility is responsible for issuing regulations on the management, use, inspection, maintenance, repair, replacement of components, preservation of medical equipment in the facility based on the manufacturer's instructions and the facility's usage requirements.

For medical equipment that is public property, it must be managed and used according to laws on managing and using public property.

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