April 27, 2020
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 Musculoskeletal Clinical Regulatory Advisers (MCRA), […]
April 24, 2020
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: Transcatheter Valve Repair Clip NMPA […]
April 24, 2020
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. Celgene, now a Bristol-Myers Squibb […]
April 20, 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 Supervision and Management of Medical […]
April 16, 2020
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 a colleague and opt-in here. […]