On June 17, 2020, Prodimed.S.A (the manufacturer) voluntarily recalled its Peripherally Inserted Central Catheter (国械注进20143036029) and Catheters Ombilicaux (国械注进20153030470), because during the re-validation of the ethylene oxide sterilization process in April, Prodimed. S.A was failed to control the weight of the sterilized tray. more…
On June 17, 2020, NMPA released eight 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 are listed in the table below. more…
On June 12, 2020, CMDE released the achievements of the China’s Scientific Action Plan on Medical Product Regulation proposed on April 30, 2019. The first batch projects in this Action Plan includes nine projects in four areas which are safety and effectiveness evaluation research of artificial intelligence more…
On June 12, 2020, CMDE released an interpretation of the Basic Principles of Safety and Performance of Medical Devices. This interpretation emphasizes that the highlight of this Principle this in the Basic Principles of Risk Management in “2.1 Summary” section. It suggests that the focus of CMDE is transferring from result-oriented to process-oriented now.
On June 5, 2020, CMDE start to collect comments on the Administrative Measures on Filing for Medical Representatives (Trail & Draft). A medical representative hereof refers to a professional who is engaged in the transmission, communication and feedback of pharmaceutical information in China on behalf of a pharmaceutical marketing license holder. more…
On June 10, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who are developing, producing or registering the GBS (Group B streptococcus) nucleic acid detection reagents. All the information is collected for compiling the Technical Guidelines for the Registration of GBS Reagents, which will guide the registration for the GBS nucleic acid detection reagents. The “Information Collection Form” shall be submitted to CMDE before June 30, 2020 via email.
On June 10, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who are developing, producing or registering the rotavirus antigen detection reagent. All the information is collected for compiling more…
On June 10, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who are developing, producing or registering the human parvovirus B19 IgM/IgG antibody detection reagent. All the information is collected for compiling more…
On June 10, 2020, CMDE released a notice about collecting information from domestic and foreign manufacturers who are developing, producing or registering the real-time fluorescence quantitative PCR analyzer. more…
On June 8, 2020, NMPA approved the registration of an innovative device — “SAPIEN 3 TAVR” made by Edwards Lifesciences LLC. The product is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
