On July 2, 2020, to further implement the Management Measures for the Adverse Event Monitoring and Reevaluation of Medical Devices, NMPA released a Writing Specification for Periodic Risk Evaluation Report of Medical Devices to standardize and guide medical device registrants for the Periodic Risk Evaluation Report writing. more…
On July 2, 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 links are listed in the table below. China Med Device suggest manufactures to follow the new requirements to do relevant registration. more…
On July 1, 2020, CMDE start to collect comments on the Technical Review Guideline for Change of Permission Items on IVD Products (Second Edition Draft). This guideline will apply to the changes of the main raw material supplier, test method, analytical performance, product technical requirements, positive judgment value or reference interval, product stability, packaging specifications, more…
On July 1, 2020, CMDE start to collect comments on the Technical Review Guideline for Citric Acid Disinfectant Registration (Draft). The main active ingredient in this Guideline is citric acid which can also contain lactic acid and malic acid. more…
On June 24, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from May 26, 2020 to June 8, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
On June 24, 2020, CMDE start to collect comments on the Technical Review Guideline for the Registration of Additive Manufactured Selective Laser Melting Metal Materials for Dental Prosthetics (Draft). This guideline will apply to selective laser melting (SLM) additive manufacturing metal materials of fixed or movable prostheses, more…
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…
