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2026 China NMPA Bluebook is here:
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.
NMPA published the notice Enhance Quality Inspection for Sterile and Implantable Medical Devices on April 14, 2020. Regulations to be Based upon Regulations for the
Here’s the latest regulatory news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to