CMD Blogs

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

China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (COVID-19) since late January. China Med Device, LLC, with its partner

On April 23, 2020 NMPA CMDE (Center of Medical Device Evaluation) granted two innovative medical device status: Microtech Medical: Continuous Glucose Monitoring System Edwards Lifesciences:

China National Medical Products Administration (NMPA) announced the suspension of importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China on March 25, 2020.