April 27, 2020

China Med Device to Hold RAPS Webinar on China & U.S Regulatory Response to COVID-19

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

NMPA: Two Devices Granted Innovation Status

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 NMPA Overseas Inspection Results in Suspension of Importation

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

Updated NMPA Quality Inspection: Sterile and Implantable Devices

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

NMPA News Roundup 202003

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. […]