From 1st January 2022 it is mandatory to use new templates to present the documentation and the technical information necessary to obtain the pre-market registration at the Chinese Regulatory Authority, National Medical Products Administration – NMPA.
Through these templates, NMPA aims to further strengthen and speed up the IVDs and Medical Devices registration process for marketing in China.
Please note that foreign Manufacturers cannot directly submit the documentation to NMPA, they need instead to appoint a Legal Agent, namely an onsite organisation acting on behalf of the Manufacturer for every registration procedure and which handles communications as well with the Regulatory Authority.
How to submit documentation for registration to NMPA?
During the last few years, China went through a transition phase during which the double dispatch of the registration dossier was allowed, both in paper and in electronic format.
Currently, in order to optimize sending and receiving times the documentation can be sent via electronic format eCopy only.
From an organisational point of view, new templates are arranged in folders and require information about devices, clinical and non-clinical data, labelling (IFU and tags), and information about the quality system.
New templates files for registering Medical Devices and in Vitro Diagnostic-Medical Devices (IVDs), such as for example the list of devices basic safety and performance principles, can be downloaded from NMPA official website.
Do you want to register your Medical Devices and IVDs in China and do you need help?
Thema experts, thanks to extra-EU international registration services, are here to support and help you with your submission procedure relating to your own Medical Devices and IVDs in China.
Contact us for further information and find out how we can help you!
Sources:
NMPA, New documents for the registration of Medical Devices, n° 121 of 2021
NMPA, New documents for the registration of IVD Devices, n° 122 of 2021
