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Ellen Jiang

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United States

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Newsletter on China Medical Device Polices from Jan-Sep,2018 Attachments

Posted By Ellen Jiang 11-Oct-2018 01:49
Found In Library: Regulatory Open Forum

Newsletter on China Medical Device Polices from Jan-Sep,2018

Posted By Ellen Jiang 11-Oct-2018 01:49
Found In Egroup: Regulatory Open Forum \ view thread
Ellen Jiang President ( RAMED (Beijing) Medical Technology Co., LTD. Tel: (+86) 13910975728 Tel: +86 10 6431 5866 (+86) 21 5866 1516 ellenjiang@ramed.top www.ramed.top

China Medical Device Regulatory Forum in Cambridge, MA

Posted By Ellen Jiang 04-Jul-2018 04:36
Found In Egroup: Regulatory Open Forum \ view thread
The medical device regulatory reform in China is changing the pattern and future of the enterprises and the whole industry at an unprecedented pace. What benefits will the enterprises gain from the reform? How should the enterprises understand and make use of these regulatory advantages? The ...

CFDA issued "Medical Device Standards Planning 2018-2020" on Jan.29, 2018

Posted By Ellen Jiang 30-Jan-2018 10:26
Found In Egroup: Regulatory Open Forum \ view thread
CFDA issued "Medical Device Standards Planning 2018-2020" on Jan.29, 2018. Based on this New Standards Planning, CFDA will establish and revise about 300 Medical Device Standards from 2018 to 2020, the key standards include the following scopes: 1. Medical Device Quality Management Standardization ...

RE: CFDA issued "Technical Guideline to accept Medical Device Overseas Clinical Data" on Jan.11, 2018

Posted By Ellen Jiang 16-Jan-2018 06:56
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Hello Vidyalakshmi, This guideline is released in CFDA website, but it is only in Chinese, please see the following link for your reference. 接受医疗器械境外临床试验数据技术指导原则发布 Sfda remove preview 接受医疗器械境外临床试验数据技术指导原则发布 该指导原则用于指导医疗器械在我国申报注册时，接受申请人采用境外临床试验数据作为临床评价资料的工作。指导原则 ...