CMD Blogs

CER (Clinical Evaluation Report) plays a vital role in the clinical pathway in China and predicate-comparison is the key element of CER. NMPA published Guideline

NMPA published the draft document of National Medical Device Quality Inspection Sampling Procedure on October 13, 2020 for feedback. Feedback needs to be submitted by

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

Here’s the latest China NMPA regulatory and clinical affairs news in September 2020 for medical device and IVDs pros. These updates are presented by China

NMPA published the final notice “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” on September 25, 2020. The draft version was released

NMPA issued nine September guidelines that cover indications of orthopedic, cardiovascular, hematology, general hospital, etc. General NMPA Guidelines September Technical guideline on medical device cybersecurity

In the third quarter of 2020, the NMPA posted recall notices regarding 26 medical devices and IVDs. Here we provide the analysis of the recalls.

As innovative devices and first-of-kind products enter the China market, the NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all

NMPA published two Q&A on orthopedic devices, addressing two frequently asked issues: Q: How to determine the mechanical performance indicators when submitting the orthopedic product