The Chinese authority NMPA has made a carton illustration for a pre-submission consultation of registration process for medical devices.
Category: China IVD RA
Overview of the Most Important IVD Regulations in China (Continually updated)
This page gives a summary of the most important in-vitro diagnostic reagent regulations in China, so regulatory professionals who are in charge of global regulatory management and do not speak Chinese can easily follow changes of the regulations. The regulations…
Complete List of Medical Device and IVD Standards in China and the International Equivalence (Continually Updated)
China has its own standard system including National Standards (GB) and Medical Industry Standards (YY), which is often confusing for foreign professionals to follow as the standards are only available in Chinese. Therefore, JMedTec has created this page to show…