CMD Blogs

NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. It is an effort to implement

A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative

In March 2018, the transformation from CFDA to NMPA, which emerged into State Administration for Market Regulation (SAMR), was to make the linkage between pre-market

NMPA published 14 guidelines in July 2020. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia and immunology, etc. Full List of Guidelines

A Periodic Risk Evaluation Report is required to submit to NMPA, depending on the initial NMPA registration time, according to Decree No. 1 Administrative Measures

NMPA issued nine orthopedic standards on July 9, 2020 to guide manufacturers for local type testing and regulatory approval. Their implementation date is June 1,

Here’s the June 2020 China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device,

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

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

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