Organizational apparatus and operation mechanisms of the Infrastructure and Medical Device Administration in Vietnam

Organizational apparatus and operation mechanisms of the Infrastructure and Medical Device Administration in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Organizational apparatus and operation mechanisms of the Infrastructure and Medical Device Administration in Vietnam

- Head of Department: Director and Deputy Directors.

+ The director and deputy director are appointed, relieved of duty, or dismissed by the Minister of Health in accordance with the law.

+ The Director of the Department is responsible to the Minister of Health and before the law for all activities of the Department, and the Deputy Director assists the Director and is assigned by the Director to be in charge of a number of tasks, responsible to the Director and to the law for the assigned tasks.

- Organizational apparatus of the Department:

+ Office of the Department;

+ Medical Works Management Department;

+ Department of registration management and sales of medical equipment;

+ Department of quality management and use of medical equipment;

+ Non-business units under the Department:

Center for support and development of works and medical equipment.

- Mechanism of action:

+ The Infrastructure and Medical Device Administration operates under the head regime;

+ The functions, tasks, and powers of the Office of the Department and the departments and organizations under the Department are prescribed by the Director on the basis of the functions and tasks of the Department. The relationship between the Bureau's Office, its divisions, and organizations shall be regulated by the Director;

+ The appointment and dismissal of leadership positions of the Office and leaders of Divisions and organizations under the Department according to the provisions of law;

+ The titles of Department leaders, Office leaders and leaders of Departments and organizations under the Department are entitled to allowances according to current regulations;

+ The recruitment of civil servants, public employees, and employees for the Department shall comply with the provisions of law and regulations of the Ministry of Health.

- Payroll:

The payroll of the Infrastructure and Medical Device Administration is determined according to the provisions of the law on employment positions and adjusted according to the needs of the positions decided by the Minister of Health.
on the basis of the proposal of the Director of the Infrastructure and Medical Device Administration.

- Funding: Operational funding of the Infrastructure and Medical Device Administration shall be provided by the state budget and other lawful funding sources.

(Article 3 of Decision 2316/QD-BYT in 2023)

2. Tasks and powers of the Infrastructure and Medical Device Administration in Vietnam

Tasks and powers of the Infrastructure and Medical Device Administration include:

(1) Development of policies and laws on the construction of medical facilities and medical equipment

- Preside over or participate in formulating and submitting to the Minister of Health for promulgation according to his/her competence, or the Minister of Health to submit to competent authorities for promulgation legal documents, national standards, national technical regulations, strategies, policies, and plans on the construction of medical works and medical equipment;

- Promulgate according to its competence, documents providing professional and technical guidance on the management of the construction of medical works and the management and use of medical equipment.

(2) Construction management of medical works

- Preside over or participate with relevant agencies in formulating and submitting to competent authorities for promulgation national technical regulations and design standards for medical works; design standards for specialized faculties and departments in medical works;

- Assume the prime responsibility for formulating regulations and guidelines on standards and norms for the use of non-business works in the medical field;

- Preside over or comment on the construction planning of units under and under the Ministry of Health and construction planning projects under the approving competence of the Prime Minister;

- Assume the prime responsibility for, and coordinate with relevant agencies in, guiding and inspecting the implementation of professional and technical regulations on the construction of medical works; guide and inspect the implementation of investment projects in the construction of medical facilities; manage the quality of medical works by units under and under the Ministry of Health; participate in the supervision and assessment of quality; check the acceptance of construction investment projects under the management of the Ministry of Health;

- Assume the prime responsibility for, and coordinate with relevant agencies in, giving opinions on functional lines and technical standards for investment projects in the construction of medical works at the request of agencies, ministries, branches, and localities;

- Participate in the development of regulatory documents on investment management in the construction of medical facilities in agencies and units under the Ministry of Health.

(3) Medical device management

- Assume the prime responsibility for developing and submitting to the Minister of Health for promulgation a list of medical equipment not subject to declaration of eligibility for purchase and sale, the list of medical devices that must be inspected, and the promulgation of inspection procedures for each type of medical equipment in the list;

- Assume the prime responsibility for, and coordinate with relevant units in, formulating and submitting to the Minister of Health for promulgation detailed regulations on standards and norms for using specialized machinery and equipment, including medical equipment, in service of medical non-business activities as prescribed by law;

- Assume the prime responsibility for carrying out the procedures for submitting to the Minister of Health for promulgation a decision: granting, suspending, or withdrawing the free-sale registration number of medical equipment; medical device recall; issue and revoke the certificate of free sale for medical equipment; promulgate documents on revocation and publicize documents on revocation of classification results of medical devices; grant import licenses for medical equipment;

- Assume the prime responsibility for managing, guiding, inspecting, and supervising according to its competence the implementation of: publicizing medical device advertising information; publicizing information and publication dossiers for raw materials for the production of medical equipment and controlled substances containing narcotics and precursors;

- Assume the prime responsibility for organizing the publicity of information and declaration of eligibility to provide medical equipment technical consulting services; issue new, re-issue, supplement, and revoke the certificate of registration of medical device inspection activities within the scope of their assigned management according to the provisions of law;

- Take the lead in guiding and organizing the publicity on the website of the Ministry of Health on: medical equipment prices in accordance with law; the list of medical devices that have been granted, with the free-sale registration number revoked;

- Preside over or participate in directing, guiding, and inspecting the implementation of legal documents, national standards, national technical regulations, and professional and technical guidelines in the use of medical equipment; organize inspections and coordinate with competent agencies in inspecting, settling complaints and denunciations, and handling violations of the law on medical equipment in accordance with the law;

- Participate in and coordinate with relevant agencies in appraising and commenting on investment projects on the procurement of medical equipment under the management of the Ministry of Health; participate in guiding and commenting on standards and techniques of medical equipment for investment projects in the medical field at the request of ministries, branches, and localities.

(4) Assume the prime responsibility for, and coordinate with related agencies and units in, building training, retraining, and human resource development needs in the construction management of medical facilities and medical equipment; organize professional training courses on the construction management of medical works and medical equipment.

(5) Assume the prime responsibility for, and coordinate with relevant units in, implementing scientific research, international cooperation, and regional and international integration into the management of medical devices under the authority of the Ministry of Health, as prescribed by law.

(6) Organize the implementation of legal work, administrative reform work, and the application of information technology in state management activities on the construction of medical facilities and medical equipment, and build and manage an information system on medical equipment in accordance with the law.

(7) Manage assigned organizations, officials, public employees, assets, and funds according to the provisions of the law and the decentralization of the Minister of Health.

(8) Perform other duties assigned by the Minister of Health.

(Article 2 of Decision 2316/QD-BYT in 2023)

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