Supplementary data pre-review service, is a consultation service provided by CMDE, whose application scope extends to initial registration, changes in licensing and approval of clinical trials of high-risk medical devices. Given the applicants only have one chance to submit the supplementary data, more…
On July 29, 2020, the medical device standard management center released a notice about information collecting on six medical device industrial standards (draft). All the six standards are listed in the table below. Opinions or suggestions are all welcomed to be filled in the information collection and registration form and submit it to the standard management center before September 30, 2020, via email. more…
On July 29, 2020, CMDE released a notice about information collecting on medical device of soft tissue repair biomaterial. This is the first batch of collection which mainly focuses on the Hernia Mesh and Dura Substitution. CMDE is collecting information from relevant units and institutions in this field, more…
On July 29, 2020, CMDE released its revision of the New and Revised Catalog of Medical Devices and ICD Products Exempted from Clinical Trials in 2020 (Draft). Devices such as Fluoroscopy Radiography X-ray Equipment, Disposable Aortic Punch, Surgical Zipper, etc. are all exempted from clinical trials now. more…
On July 29, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from June 9, 2020 to July 6, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
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…
