Recently, the Ministry of Health issued Circular 05/2022/TT-BYT detailing the implementation of several articles of Decree 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical equipment. get medical. The new point in Circular 05/2022/TT-BYT must be mentioned is the classification of medical equipment, this content has partly overcome the difficulties and obstacles in the effective management and control of the problem. purchase medical equipment. This content will be presented in more detail through the following article:
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Accordingly, for the classification of medical equipment, medical equipment is classified according to one or a group to determine the level of risk and the level of circulation number. The determination of risk levels according to A, B, C, and D levels is based on classification rules. Medical equipment that is not medical equipment for in vitro diagnostics has 16 classification rules; In vitro, diagnostic medical devices have 7 classification rules.
In addition to the new classification, the regulations on the implementation roadmap also have the following highlights: for medical equipment such as ventilators, anesthesia machines with breathing apparatus, and electric scalpels, if purchased after the date of purchase. On December 31, 2022, medical equipment must be tested for safety and technical features by the inspection process promulgated by the Minister of Health. If purchased before January 1, 2023, medical equipment must complete the inspection before June 1, 2023, by the inspection process issued by the Minister of Health.
For medical equipment that is an infant incubator, defibrillator, and hemodialysis machine, if purchased after December 31, 2022, the medical equipment must be tested for safety and technical performance. according to the inspection process promulgated by the Minister of Health. If purchased before January 1, 2024, medical equipment must complete the inspection before June 1, 2024, by the inspection process issued by the Minister of Health.
In addition, Circular 05/2022/TT-BYT also has some new highlights such as:
- Supplementing the list of in vitro diagnostic medical equipment that is not subject to quality assessment by Vietnamese competent authorities;
- The list of medical equipment of types B, C, and D that can be bought and sold like ordinary goods;
- List of medical equipment that must be inspected for safety and technical features; the list of medical equipment licensed for import.
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Circular 05/2022/TT-BYT detailing several articles of Decree 98/2021/ND-CP on the management of medical equipment takes effect from August 1, 2022.
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