On June 5, 2020, NMPA released five guidelines for medical devices to strengthen the surveillance and guidance of the registration of medical device products and further improve the quality of registration review. All the new guidelines and their links are listed in the table below. more…
On June 5, 2020, CMDE start to collect comments on the Technical Review Guideline of Medical Device Software (Draft Edition 2). This guideline may have an impact on the registration of the self-developed software, off-the-shelf software, and Class II or Class III SaMD (software as a medical device) and SiMD (software in a medical device). more…
On June 5, 2020, CMDE released details for further standardizing the filing review procedure to improve the filing review quality and efficiency. For example, CMDE conducts data review by the filing review requirements in the acceptance process. Theoretically, where additional information is required, the reviewer shall release a supplementary requirement at one time.
Link: https://www.cmde.org.cn/CL0004/21037.html
On June 5, 2020, CMDE released a notice about the application withdrawal and re-application process for the imported Class III medical devices that were initially registered as Class II devices in China. Recently, CMDE found many imported medical devices were applied to be registered as Class II medical devices while they are identified as Class III devices after review. more…
China’s Center for Medical Device Evaluation (CMDE), a division of NMPA announced its preparation of “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs” on June 3rd, 2020. CMDE is collecting the CDx manufacturer’s information. Whether you are an IVD or drug/pharmaceutical manufacturer in or outside of China, you have an opportunity to have your companion diagnostic needs for the clinical trial heard in the co-development of CDx reagents and anti-tumor drugs. more…
On June 4, 2020, NMPA released the SaMD Onsite Audit Technical Guideline for Medical Device Good Manufacturing Practice in order to better supervise the implementation of GMP and its “Independent Software Appendix”. This guideline regulates the following details in the manufacturing process: more…
On June 4, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who are developing, producing or registering the IgM/IgG antibody detection reagents for mycoplasma pneumoniae. All the information is collected for compiling the Technical Guidelines for the Registration of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents, more…
On June 1, the Overall Plan for the Construction of Hainan Free Trade Port, formulated by the CPC Central Committee and the State Council, was officially released. The medical field plays a vital role in the 60 key policies of the plan, i.e., “support to develop cross-border medical insurance products in cooperation with overseas institutions” and “build a regional medical center”. more…
On June 3, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who have approved products or intend to be engaged in the production of CDx (Companion Diagnostics). All the information is collected for compiling the Technical Guidelines for the Clinical Trials of CDx Simultaneously Developing with Anti-tumor Drugs, which will guide the clinical trial conduction for the CDx registration application.
On May 29, 2020, the National Health Commission decided to postpone the declaration of the configuration license for Class A large medical equipment in 2020 due to the impact of COVID-19. The second round of the expert review for the configuration of Class A large medical equipment in 2019 was affected by the epidemic so the remaining number for the configuration plan of Class A large medical equipment in 2020 cannot be determined temporarily.
Link: http://www.nhc.gov.cn/caiwusi/s10743/202005/2d281f6219fa4c7e8826ee13e27153c0.shtml
