一次性使用无菌医疗器械监督管理办法（Measures for the supervision and administration of disposable sterilized medical instruments）.docVIP

一次性使用无菌医疗器械监督管理办法（Measures for the supervision and administration of disposable sterilized medical instruments） Chapter I General Provisions Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices for the purpose of strengthening the supervision and administration of the sterilized medical apparatus for the use of one-off use, and ensuring the safety and effectiveness of the products. The term aseptic medical instruments (hereinafter referred to as sterile instruments) as mentioned in the present Measures refers to medical instruments that are sterile, pyrogen free, and qualified for inspection and are used directly within the period of validity for the duration of the term of validity. (second). The sterile instruments shall be supervised and managed according to the catalogue of disposable sterile medical instruments (hereinafter referred to as the catalogue). The catalogue (see Annex) shall be promulgated and adjusted by the State Drug administration. Article third all units or individuals engaged in the production, operation, use, supervision and administration of sterile instruments within the territory of the Peoples Republic of China shall abide by these measures. [editor this paragraph] second chapter supervision and management of production Fourth production of sterile equipment should be implemented by the State Drug Administration promulgated the sterile medical device production management norms and sterile equipment production implementation rules.. Sterile instruments must be inspected in strict accordance with the standards, and those who have not been inspected or inspected are not allowed to leave the factory. Fifth production of sterile equipment should be in accordance with the rules for the implementation of the production requirements of the procurement of materials, components. The enterprise shall keep complete purchasing and sales notes and records, and the notes and