天际彩票
喜報!恭喜萬孚公司拿下MDSAP證書!
發布時間:2019-02-25 15:14:31

        2019年2月20日,廣州萬孚生物技術股份有限公司(以下簡稱“萬孚生物”或“公司”,證券代碼:300482)收到了由南德意志集團TüV 簽發的MDSAP證書,標志著公司順利完成了MDSAP體系的國際質量體系認證。



        作為國內POCT行業領跑者,萬孚公司此前已通過了IS09001:2015、IS013485:2016、美國FDA、世界衛生組織WHO PQ等質量體系審核。

        此次通過MDSAP認證,意味著公司的質量體系同時獲得美國(FDA)、加拿大(HC)、巴西(ANVISA)、澳大利亞(TGA)等多個國家監管機構的認可,對公司發展尤其是海外市場帶來重要的積極影響。


什么是MDSAP認證?


        MDSAP,即醫療器械單一審核程序(Medical Device Single Audit Program),是國際醫療器械監管機構論壇(IMDRF)成員共同發起的項目。MDSAP是基于ISO 13485,覆蓋美國(FDA)、加拿大(HC)、澳大利亞(TGA)、巴西(ANVISA)、日本(MHLW)法規要求的醫療器械質量管理體系要求。該程序旨在開發、管理、監督一項單一審核程序,這一程序將允許對由MDSAP認可的審核組織對醫療器械制造商進行一次法規審核來滿足多國法規要求。目前,中國、歐盟和WHO也以觀察員的身份參與其中。



萬孚生物MDSAP認證歷程


前期準備階段

        2017年底正式立項,開始對MDSAP法規要求進行解讀及差距分析,對自身體系做法規符合性準備工作。


認證審核階段

        2018年8月,進行第一階段正式審核,并于10月進行第二階段正式審核,兩個階段的審核工作皆順利完成。


審核收尾階段

        在完成審核報告跟進后,于2019年2月,公司收到由南德意志集團TüV 簽發的MDSAP證書。



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