China’s overhaul of medical device and IVD regulations could mean huge benefits. Manufacturers have additional options for fast-track approvals and more flexible testing / clinical-evaluation pathway requirements. Is your company positioned to benefit from a faster and less-costly market entry?
Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China today. This 2022 annual NMPA (CFDA) Blue Book provides with a snapshot of 2021 changes and impacts on 2022.
Get it today with the completion of survey below:
This 70+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements:
For a 15 minute complimentary consultation on the impacts of these changes to your business, please indicate it when you submit your survey.
“The China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.”
— Mr Gong Zhi Jun, Director Administration Institute of Executive Development NMPA