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The on-site promotion of the production quality management standard of medical devices in The province will be held in Hangzhou

Click:81 Time:2020-05-14 14:35:41

   为进一步推进永利皇宫会员登录系统生产质量管理规范的全面实施,树立规范企业引领示范作用,全省永利皇宫会员登录系统生产质量管理规范现场推进工作会日前在杭州市召开。省局苏志良总工程师、省局器械处负责人、各市局永利皇宫会员登录系统监管处负责人以及杭州各区、县(市)永利皇宫会员登录系统监管有关负责人参加此次推进会。
   在推进会上,省局通报了全省永利皇宫会员登录系统生产质量管理规范情况及5家规范示范企业创建情况,杭州市局、温州市局在推进会上分别做了经验交流,介绍了一二类一类器械生产企业质量管理规范推进实施情况,其他市局汇报了辖区内规范推进进度及下一步工作措施等。此后,省市永利皇宫会员登录系统监管负责人实地参观考察了一家二类永利皇宫会员登录系统生产企业——永利皇宫登录网址的质量体系保障运行情况。
   苏志良总工程师肯定了目前各地规范实施推进的工作进展,强调永利皇宫会员登录系统生产企业从2018年1月1日起全面实施GMP是国家总局全面推进永利皇宫会员登录系统质量体系保证和推动监管的重要要求,各地监管部门认真抓好现场核查。他再次强调了尽管今年规范核查任务重,强度大,但是各监管部门不能放松核查标准,特别是对一类生产企业也要按照规范的要求实施,该整改的整改,该停产的要停产,同时要加强示范引领,确保这项工作目标全面完成。


In order to further promote the full implementation of the production quality management standards of medical devices and set up the exemplary role of normative enterprises, the on-site promotion work of the production quality management standards of medical devices of the whole province was held in Hangzhou a few days ago.Su Zhiliang, chief engineer of the provincial bureau, responsible person of the equipment department of the provincial bureau, responsible person of the medical device supervision department of the municipal bureau, and responsible person of the medical device supervision of hangzhou district, county (city) attended the promotion meeting.


At the propulsion ShengJu notified by the provincial medical equipment production and the quality control standard for demonstration enterprises create conditions and five specifications, city bureau of hangzhou, wenzhou city bureau respectively for the exchange of experience in promoting meeting, introduced a second class of equipment manufacturing enterprises and the quality control standard for advancing the implementation of other city bureau to report the standard measures to promote the progress and future work within their respective jurisdictions.After that, the provincial and municipal medical device supervisors visited a second-class medical device manufacturer -- Zhejiang Ganevi Medical Technology Co., LTD., and investigated its quality system guarantee operation.


Chief Engineer Su Zhiliang affirmed the current progress of the implementation of local standards, and stressed that the full implementation of GMP in medical device manufacturers from January 1, 2018 is an important requirement for the General Administration of China to comprehensively promote the assurance of medical device quality system and promote supervision, and local regulatory authorities pay close attention to on-site inspection.He once again stressed that although the task of standardized verification is heavy and intensive this year, all regulatory authorities cannot relax the verification standards. In particular, a class of production enterprises should also be implemented in accordance with the requirements of the standards. The rectification should be carried out and the suspension of production should be suspended.



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