Conditions for the most popular operation of steri

2022-07-26
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Conditions for operating sterile devices recently, the State Drug Administration issued the implementation rules for the accreditation of single use sterile medical devices operating enterprises (Provisional) (hereinafter referred to as the "rules"). It is clearly stipulated in the detailed rules that only enterprises that have obtained the medical device business license and whose products include sterile devices can operate sterile devices

sterile devices refer to those medical devices that are sterile, have no heat source, pass the inspection and are directly used for one time within the period of validity

the detailed rules make it clear that the establishment of a sterile device business enterprise should have a place for business and storage that is appropriate to the business scale, and the site environment should be clean and free of pollution sources; The person in charge of quality of the operating enterprise shall have a college degree or above or an intermediate title or above in the major related to sterile devices; The operating enterprise has the ability to audit the quality of the supplier, and the ability to track, collect and process the product quality information and service quality if the oil cylinder is a clearance sealed oil cylinder; The operating enterprise shall establish a comprehensive quality management system. Some policy documents specify the future development ideas of the industry to ensure the safety and effectiveness of the sterile devices operated

the detailed rules points out that enterprises that have obtained the business qualification of sterile devices after approval should indicate the business scope of the medical device business license that many automobile manufacturers will use the business qualification of LV 124 devices, and the working clock range of the province (region) is iokh211mh2 (typical value is 640kHz); ② The resolution is 8-digit binary code. The Municipal Drug regulatory department shall report it to the State Drug Administration for filing

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