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
On May 29, 2020, CMDE offers further explanation for the registration unit division of interbody fusion cage products. According to CMDE, the composition material of the product body (including material brand number) should be divided into different registration units. Based on the common materials of the body of the interbody fusion cage products, it can be divided into more…
On May 29, 2020, CMDE further introduces benefits of the Intelligent Assignment of medical device registration and evaluation. With an intelligent assignment application added in the eRPS system for the evaluation, the evaluation and approval process is much more efficient. In addition, with the increase in the proportion of intelligent assignment, it minimizes the human intervention in the registration and evaluation process.
