CMD Blogs

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.

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

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

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

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

China Periodic Risk Assessment Evaluation Report China’s NMPA now requires your submission of a Periodic Risk Assessment Evaluation Report, based on the initial NMPA registration

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The program, which has been piloted in Hainan

Here’s April’s NMPA news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a

NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. The impacted reagents include but

Premier Li Keqiang of China, center, speaking at the Jinyintan hospital in Wuhan/ Reuters The Chinese government is moving to enhance quality inspection and export

On April 10, the NMPA issued the “Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring”. Based on Decree 1 Medical

China mandated electrical medical device manufacturers to comply with its national mandatory standard GB 9706.1-2007, equivalent to IEC 60601-1 Edition 2, since 2008. Even though