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Six Recalls Released by NMPA

On September 18, 2020, six overseas manufacturers voluntarily recalled five different medical devices. All these recalls are Class II Recalls. more…
Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval

On September 18 2020, CMDE released an amendment of the Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval (Amendment 2020). more…
NMPA Approved 96 Medical Devices in August 2020

In August 2020, NMPA has approved a total of 96 medical devices. 57 of them are domestic Class III medical devices, 13 of them are imported Class III medical devices, more…
Green Pathway for 4 New Innovative Medical Device

On September 16, 2020, NMPA intends to allow the following applications to be subject to the innovative green pathway review procedures: Bowel Polyp Colonoscopy Assisted Detection Software made by Wision A.l., more…
Suggestion Collection for Making and Revising the Working Plan on Medical Device Registration Review in 2021

On September 14, 2020, CMDE announced a notice to collect suggestions on 2021 medical device registration review work plan. This plan compilation includes a proposal on technical review guidelines for medical device registration more…
Stent Retrievers

On September 11, 2020, NMPA approved the registration of the “Stent Retrievers” produced by Ton-Bridge Mediacal Technology Co.,Ltd. The innovative device has the following advantages: more…
New China Clinical Trials with HGR Filing

On September 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from August 4, 2020 to August 17, 2020 on human genetic resources in China. more…
Technical Review Guideline on the Medical Device Cybersecurity (Version II)

On September 8, 2020, CMDE announced its preparation of Technical Review Guideline on the Medical Device Cybersecurity (draft). This Guideline is the second version draft on the cybersecurity issues of the medical devices. more…
Green Pathway for 2 New Innovative Medical Device

On September 7, 2020, NMPA intends to allow the following applications to be subject to the innovative green pathway review procedures: more…
Five Recalls Released by NMPA

On September 4, 2020, five overseas manufacturers voluntarily recalled five different medical devices. These recalls include Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. more…
China UDI Database Launched: 97,258 Device Identifiers Already Uploaded

NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take effect on October 1, 2020. more…
Technical Guideline on the Registration of Predicate Clinical Evaluation of Ultrasonic Soft Tissue Cutting Hemostatic Systems

On September 3, 2020, CMDE announced its preparation of Technical Guideline on the Registration of Predicate Clinical Evaluation of Ultrasonic Soft Tissue Cutting Hemostatic Systems (draft). more…

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