Chương X Nghị định 98/2021/NĐ-CP: Quản lý, sử dụng trang thiết bị y tế tại các cơ sở y tế

Chapter X

MANAGEMENT AND USE OF MEDICAL DEVICES BY HEALTH FACILITIES

Article 63. Rules for management and use of medical devices

1. Medical devices must be properly managed and used to ensure their functions as well as economical and effective use.

2. Medical devices shall be stored, maintained and used in accordance with the manufacturer's instructions, and must undergo quality in accordance with regulations of this Decree.

With regard to medical devices subject to strict occupational safety and health requirements, regulations of the Law on occupational safety and health must be strictly complied in addition to regulations on quality control laid down in this Decree.

3. Documents on medical devices must be adequately prepared, managed and retained; medical devices shall be sufficiently and punctually recorded according to their actual state and values in accordance with regulations of laws on accounting and statistics and other relevant laws; funding for performing tasks prescribed in Clause 2 of this Article must be ensured.

4. Health facilities shall bear inspection of regulatory authorities in charge of managing medical devices.

Article 64. Management and use of medical devices by State-owned health facilities

In addition to the provisions of Article 63 of this Decree, State-owned health facilities shall comply with the following provisions:

1. Investment in, purchase, management and use of medical devices shall comply with regulations of law on management and use of public assets.

2. Use of domestically manufactured medical devices is encouraged.

Article 65. Rights and responsibilities of health facilities for management and use of medical devices

1. Each health facility shall have the following rights:

a) Request the registration number holder or the warranty center recognized by the product owner to provide periodical maintenance of medical device during the warranty period;

b) Request the seller to provide technical documents of the medical device;

c) Receive the used medical devices to serve their scientific research and training in use and repair of medical devices.

2. Each health facility shall have the following responsibilities:

a) Use and operate the medical device according to instructions of the product owner;

b) Carry out periodical maintenance, inspection and calibration according to instructions of the product owner or as prescribed by law;

c) Participate in testing for and assessment of quality of medical devices;

d) Submit reports on defective medical devices and provide other information at the request of competent authorities.