The Rules for Unique Device Identification System in China is issued by the NMPA/CFDA on August 23rd, 2019 and effective from October 1st, 2019. The UDI shall be composed of product identifier and manufacturing identifier. The product identifier shall be…
Author: jmedtec0
List of Innovative Devices Approved to Enter Green Channel Registration (Continuously updated)
List of Prioritized Devices Approved to Enter Green Channel Registration (Continuously updated)
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…
Guidelines for Specific Medical Devices (Continually Updated)
The NMPA (ex-CFDA) has also published lots of product-specific guidelines for technical review and clinical trials. JMedTec has summarized the complete list of all the guidelines as below. Please use the product keywords to search whether any guidelines are relevant…
Overview of the Most Important Medical Device Regulations in China (Continually updated)
This page gives a summary of the most important medical device 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 are…
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…
ICH Guidelines adopted in China (Continually Updated)
China Drug Regulation Summary
CFDA Drafts a New Regulation for Medical Device Clinical Trial Inspection
June 1, 2018- The China Food and Drug Administration (CFDA) requested public comments on “Medical Device Clinical Trial Inspection Essentials and Decision Principles (Draft)”. This guidance is to strengthen the supervision and management of the medical device clinical trial. CFDA…