On July 22, 2020, NMPA intends to allow the following application to be subject to the innovative green pathway review procedures: Continuous Glucose Monitoring (CGM) System made by Shenzhen Sisensing Co., Ltd.
Link: https://www.cmde.org.cn/CL0004/21324.html
On July 2020, Beckman Coulter, Inc. (the manufacturer) voluntarily recalled the LDH (product name) due to the content differences in its English and Chinese IFU. The English IFU describes the stability of bottle opening for 21 days; however, the Chinese IFU describes the stability of bottle opening for 30 days. more…
On July 21, 2020, CMDE announced its preparation of the Technical Review Guidelines of Nitrous Oxide Delivery Systems. These guidelines apply to nitrous oxide delivery systems which are Class III medical devices in China according to the Classification Catalogue of Medical Devices drew up by NMPA. more…
On July 16, 2020, CMDE announced its preparation of 14 technical guidelines and a list of all these guidelines are listed below.
CMDE is collecting information from domestic and foreign manufacturers, universities, research institutes and clinical institutions, etc. who have relevant research experience. more…
On July 15, 2020, CMDE announced its preparation of the Technical Review Guidelines of Vision Screening Device (Draft). These guidelines apply to vision screening devices but not to optometrists (including desktop and handheld optometrists). more…
On July 14, 2020, CMDE announced its preparation of Technical Review Guidelines of Electronic Upper Gastrointestinal Endoscope (Draft). These guidelines are applied to electronic upper gastrointestinal endoscopes (excluding electronic duodenal endoscopes). more…
On July 10, 2020, CMDE announced its preparation of Framework Guidelines for Evaluating the Safety and Effectiveness of Nanomaterials Used in Medical Devices.
CMDE is collecting information from domestic and foreign manufacturers, universities, research institutes and clinical institutions, etc. who have relevant research experience. more…
In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market approval and post-market surveillance, to strengthen the market supervision for pharmaceutical and medical device products’ lifecycle, and to utilize the administrative resources in SAQSIQ to prevent bribery. more…
