The Chinese authority NMPA has made a carton illustration for a pre-submission consultation of registration process for medical devices.
Category: Resources
NMPA Overseas Audit at Medtronic, Inc. in the USA (2019/03/05)
License Holder: Medtronic, Inc. Address of License Holder: 710 Medtronic Parkway N.E. Minneapolis MN 55432 USA Manufacturing Site: 3800 Annapolis Lane Plymouth, MN 55447, USA. China Agent: Medtronic Shanghai Product: Artificial heart valve Type of Inspection: Regular Supervision Guidelines for…
China issues revised drug administration law on August 26th, 2019
On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001. In the updated drug law, the concept of marketing authorization holder…
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…