Register for Upcoming Webinar on DEC. 8 @ 11AM
2024 China NMPA Bluebook is here:
According to Article 29 in the “Administrative Decree for the IVD Reagents Registration” (CFDA, No. 5), the clinical exempt IVD reagents will need the clinical performance evaluation based on the assessment of products’ intended use, interference factors, comprehensive literature review and other non-clinical-trial methods.
China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA
China’s new requirements for CERs (Clinical Evaluation Reports) and CTs (Clinical Trials) have now been in place for more than two years. Understanding the difference and their appropriate use can
Email: info@chinameddevice.com
Phone: 978-390-4453
USA Office:
1 Broadway, 14th Floor
Cambridge, MA 02142
CHINA Office:
Suite 1702C, Beijing Hailongshiyou Building, Chaoyang District, Beijing