Reader Nguyen Nga asked: "In addition to the list of medical equipment that must be inspected for safety and technical features according to the provisions of Article 5 of Circular No. 05/2022/TT-BYT, do other medical equipment that are measuring instruments have to be inspected and calibrated before being put into use for medical examination and treatment services?
Specifically, does the Symplicity machine (imported goods) with a temperature sensor need to be inspected and calibrated before being put into use for medical examination and treatment services?
Regarding this issue, the Ministry of Health responded as follows:
Article 55 of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management stipulates:
"Article 55. Principles of inspection and calibration of medical equipment
1. Medical equipment on the list announced by the Minister of Health must be inspected for safety and technical features before being put into use (except for the cases specified in Article 57 of this Decree), periodically, and after major repairs. Inspection of medical equipment that are measuring instruments and radiation equipment shall be carried out in accordance with the provisions of Clause 2 of this Article.
2. Medical equipment that is a measuring instrument or radiation device must be inspected and calibrated according to the provisions of the law on measurement and atomic energy".
Currently, medical equipment that is a group 2 measuring device must comply with the regulations on inspection and calibration (list, frequency, etc.) according to the provisions of the law on measurement stipulated in Circular No. 07/2019/TT-BKHCN dated July 26, 2019 of the Minister of Science and Technology amending and supplementing a number of articles of Circular No. 23/2013/TT-BKHCN dated September 26, 2013 of the Minister of Science and Technology regulating measurement for group 2 measuring devices and Circular No. 23/2013/TT-BKHCN. It is recommended to review the provisions of the Circular for appropriate application.
For the specific equipment as mentioned in the petition, the Ministry of Health has no basis (detailed information, technical records, circulation records, etc.) to determine the inspection and calibration of the equipment; it is recommended to specifically study the equipment and its records to apply the regulations on inspection and calibration mentioned above.
