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 […]