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. […]
April 16, 2020

Regulatory Guidance on COVID-19 Give IVD Manufacturers Lessons on Seeking China Approval

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

NMPA under Pandemic: Record Number of Guidelines and Standards Issued in March

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 […]