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
China National Center for Biotechnology Development released the results of urgent approved HGR administrative licensing for medical devices. Details of the approved medical device are listed in the table below. This project is an international cooperative scientific research of China National Center for Biotechnology Development. more…
Since the electronic Regulated Product Submission (eRPS) system was implemented on June 24, 2019, CMDE has issued 2,626 Certificate Authority (CA) by December 31, 2019. The number of medical device registration applications submitted through online channels has reached 10,652, accounting for 80% of the total registration applications, which makes the working process more effective and convenient. more…
In March, 2020, NMPA has approved a total of 172 medical devices. 131 of them are domestic Class III medical devices, 18 of them are imported Class III medical devices, 22 of them are imported Class II medical devices and 1 of them is from the Taiwan medical device.
Link: http://www.nmpa.gov.cn/WS04/CL2121/376511.html more…
On March 25, 2020, CMDE released an announcement of review results on green pathway for two innovative medical devices, i.e., “Multi-branch Artificial Vascular Endurant Stent Graft System” and “Metal 3D Printed Sacrum Fusion” from Percutek Therapeutics and AK Medical respectively.
On April 15, 2020, CMDE released a notice of adjusting the notarial documents for some of the medical device registration applications. This adjustment mainly focuses on the submission time and form considering the global spread of COVID-19, e.g., the notarization dossiers could be submitted during the supplementary phase due to the overseas notarization process delayed. NMPA will accept the e-notarization form from overseas manufacturers. Bradynuoen can provide the turnkey solutions to manufacturers for China entry. more…
On April 14, 2020, NMPA released a notice of strengthening surveillance of sterile and implantable medical devices from four aspects: inspection objects, inspection key points, inspection method and work requirements. Especially for the inspection key points of the manufacturing, circulation and application processes are clearly specified in this notice. Since China NMPA enhances the post-market surveillance, Bradynuoen can help manufacturers review the relevant process in compliance to China regulations. more…
On April 10, 2020, NMPA released a notice for providing a guideline for adverse event surveillance by medical device registration applicants. This guideline is to guide and standardize the medical device registration and filing applicants in the surveillance of adverse events. NMPA is enhancing post market surveillance since 2018, and will do overseas onsite facility inspection. Bradynuoen can provide training and mock up inspection on overseas facility. more…
On April 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 17, 2020 to March 30, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
On April 9, 2020, NMPA announced that 12 medical device industry standards and an amendment have been approved. Details about the standards and amendment is listed in the table below for your reference. Bradynuoen can help manufacturers to evaluate the gap between your products and new guidelines.
