On May 7, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Orthopedic Surgical Navigation and Positioning System” and “Blood Flow Guidance Device for Intracranial Aneurysms” from Suzhou Microport Changxing Robot co. Ltd. and AccuMedical respectively.
On April 29, 2020, NMPA released a national annual report on adverse events (AE) surveillance of medical devices. This report focuses on six aspects of the medical devices in China: working process of their AE surveillance; their overall AE report; the statistical analysis of their AE report; information release of AE; their alert release status; and other relevant situations. more…
On April 29, 2020, NMPA approved the registration of an innovative device — “Cardiovascular OCT System and Accessories” from VIVOLIGHT. The product is used in patients who need intracavitary interventional therapy, especially widely used in stent implantation.
On April 29, 2020, NMPA approved the registration of an innovative device — “Innovation Approval of RNF180 / Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method)” from Biochain (Beijing) Science-Technology.Inc.. It is the first gastric cancer auxiliary diagnostic product to detect the methylation of RNF180 and Septin9 gene (the innovative tumor standard substance) by fluorescence quantitative PCR.
On April 29, 2020, NMPA approved the registration of an innovative device — “Reewarm ® PTX” from Shanghai MicroPort Endovascular MedTech Co., Ltd. The product is used for balloon dilation of the femoral popliteal artery (except the inferior genu artery) in percutaneous intracavitary angioplasty to treat atherosclerotic stenosis or occlusion.
On April 27, 2020, an Announcement No.12 (2020) of the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation was released on further enhancing quality oversight for exported epidemic prevention and control supplies. Measures to enhance quality oversight and step up export regulation for epidemic prevention and control supplies are emphasized in this announcement. more…
On April 26, 2020, NMPA released an updated Drug GCP (Good Clinical Practice) which was amended by NMPA and National Health Commission of the People’s Republic of China. This updated Drug GCP, which will enter into force on July 1, 2020, is profoundly modified comparing to the old version in 2003. China GCP is more approaching to ICH, which will make China clinical study harmonized with the international practice.
On April 26, 2020, NMPA released an amendment for the Biological Products Appendix of GCP (Good Manufacturing Practice) of Medical Products and this amendment will enter into force on July 1, 2020. As for Article 59 of the appendix, due to a certain period required for information construction, manufacturers recording data via information system for real-time data collection shall meet the relevant requirements before July 1, 2022.
NMPA intends to make adjustment of the Classification Catalogue of IVD (in vitro diagnostic) Reagents (2013 edition), and 29 IVD reagents were selected to be modified in their classification and intended use. NMPA is now collecting public opinions on the contents of the proposed adjustment and relevant opinions should be submitted by May 10. 2020.
The press conference host on April 26, 2020, focusing on enhancing the supervision of export medical devices for epidemic control provides answers to the media in regard of the export of non-medical masks, standardize export regulations, quality surveillance of epidemic control materials, emergency approval of medical devices, etc. According to NMPA official, Wang Shucai, as of April 24, as many as 10,307 inspectors were sent to 1,216 medical device manufacturers that have started or were preparing to start exporting for quality tests, examining samples of 417 batches of products. Since China NMPA enhances the product surveillance, Bradynuoen can help manufacturers with the NMPA overseas audit.
On April 22, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 31, 2020 to April 13, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.
Link: http://www.cncbd.org.cn/Notice/Detail/9245
On April 23, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Continuous Glucose Monitoring System” and “Transcatheter Valve Repair Clip” from Microtech Medical and Edwards Lifesciences LLC respectively.
Link: https://www.cmde.org.cn/CL0004/20808.html
