The Second China International Import Expo (CIIE) was held in Shanghai from November 5 to 10, 2019.The rapid growth of medical devices and health market attracts enterprises from all countries to enter China’s big market. CIIE is quite a rare…
Author: jmedtec0
Must-read: NMPA Pre-submission consultation of Registration process for medical devices
The Chinese authority NMPA has made a carton illustration for a pre-submission consultation of registration process for medical devices.
NMPA officially joined the IMDRF National Competent Authorities Report information exchange mechanism
On September 19, at the 16th management committee meeting of IMDRF held in Yekaterinburg, Russia. The application to join National Competent Authorities Report information exchange mechanism of IMDRF submitted by the Chinese delegation was unanimously approved by the member states.…
China starts to implement UDI for certain Implantable Devices
On October 15th, 2019, Chinese National Medical Product Administration (NMPA) announced 64 types of medical devices required for the UDI implantation. All of them are classified as class III. Those devices listed shall be produced with UDI after October 1st,…
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…
China NMPA issued the Rules for Unique Device Identification System on August 23rd, 2019
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…
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…