Year: 2020

With an announcement on October 20, 2020, the NMPA reclassified 29 cancer biomarker-related reagents from Class III to Class II. Additionally, they modified its intended use. The draft version for

Thirty four industry standards for medical devices were issued by the NMPA on October 22, 2020. These were put in place to guide manufacturers for local type testing, clinical trials,

The NMPA issued a notice called “the Establishment of Medical Robotics Standardization Agency” on September 27. This is announcing the regulatory preparation for medical robotics. The agency is responsible for

NMPA granted priority review designation to CooperVision and Biomerieux on September 30, and gave its reason as below: Soft hydrophilic contact lens, by CooperVision, on the ground that it is

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 on Technical Review on Predicate-Comparison

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 November 12, 2020. The National

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

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 Med Device, LLC, your partner

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 on March 5, 2020. The

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 (draft) Technical guideline on verification

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. According to Decree No. 1