On June 24, 2020, CMDE start to collect comments on the Technical Review Guideline for Evaluation Method Establishment and Characterization of Unknown Leachables in Medical Devices (Draft). This guideline can apply to medical device registration or product development process. more…
On June 24, 2020, CMDE start to collect comments on the Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval (Draft 2020). NMPA drafted this new edition Catalog base on the current Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval. This new Catalog more…
On June 24, 2020, NMPA released a notice on the cancellation of two medical device registration certificates. The two devices are the Metal Bone Screws (国械注准20153461528) made by Shandong Wendeng Zhenggu Yantai Hospital Co. LTD and the Single-use Puncture Set and Cannula for Local Anaesthesia (国械注准20163662291) made by Ningbo Junma Medical Apparatus Co., Ltd. more…
On May 19, 2020, NMPA has approved a total of 135 medical devices. 79 of them are domestic Class III medical devices, 21 of them are imported Class III medical devices, 32 of them are imported Class II medical devices and 3 of them are from Hong Kong, Macao and Taiwan. more…
On June 18, 2020, Arrow International, Inc. voluntarily recalled its product, AutoCAT 2 and AutoCAT 2 WAVE (国械注进20153211603、国械注进20153081603、国食药监械（进）字2011 No.3211652). The product involved may have a component in IABP vulnerable to vibration failure, which will eventually cause a sudden stop or failure to start IABP. more…
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.
