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. […]
April 16, 2020
Under the COVID-19 crisis, China’s health regulators demonstrated unprecedented speed in providing approvals in mere weeks for needed medical devices, particularly for diagnostic test kits. Jiangsu provincial NMPA approved the […]
April 11, 2020
Despite the global outbreak of novel coronavirus (COVID-19), NMPA published 16 guidelines and 43 standards in March, guiding manufacturers with type testing and registration. For English version of any documents […]