July 9, 2020

NMPA is Revising Clinical Trial Approval Catalog

As innovative devices and first-of-kind products enter China market, NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical approval to […]
July 8, 2020

In One Day, Two AI Diagnostic Software Go into NMPA Fast-Track Channel

NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020: Innovation Status Zhiyuan Huitu: Assistance software for fundus diagnosis Priority Review Status Hangzhou Yitu: Assistance software […]
July 2, 2020

Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained NMPA Innovation Approval

NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020. Balloon Technology The product includes transcatheter […]
June 30, 2020
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CMD New Webinar! Learn China Mandatory Period Risk Evaluation Report (PRER) and the latest PMS Requirements in China NMPA and US FDA

Thursday, July 9, 2020 | 12:00 pm – 1:10 pm ET Register Now! China has been increasing its surveillance on post market monitoring with more regulations and random inspections both […]
June 22, 2020

NMPA Updates: Four Orthopedic Guidelines Published in One Day

NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval. Registration Guideline on 3D printed acetabular cup products Registration Guideline on […]
June 22, 2020

China Real World Data Adoption: Faster Introduction for Urgently Needed Devices

 “Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. This important document mandates the qualification […]
June 18, 2020

86 NMPA Standards to be Issued in 2020: Cosmetic Surgery, Cardiovascular and More

NMPA issued the finalized version of 2020 Medical Device Industry Standards Revision Plan on May 19, in which 86 medical devices and IVDs are affected. The Standards Revisions are aimed […]
June 12, 2020

NMPA News Roundup May 2020

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros from May 2020. These updates are presented by China Med Device, LLC, your partner […]
June 9, 2020

Feedback Needed for CDx Guideline by China NMPA

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 4, 2020

Record Number of Devices Obtain Innovation Status in May

NMPA granted innovative status to nine medical device manufacturers in May, including three foreign manufacturers and six domestic ones. Neurology Rapid Medical: Thrombectomy stent (Imported device) Keystone Heart: Anti-embolization distal […]
June 1, 2020

NMPA Guideline on Raw Material Changes for Non-active Devices: Eleven Examples

NMPA implemented the “Guideline on Raw Material Change Evaluation of Non-active Device” on May 19, 2020. The guideline has gone through modifications since the draft feedback was released on June […]
May 27, 2020
China periodic risk evaluation report

Periodic Risk Evaluation Report: China’s NMPA Further Specifies PMS Requirements