Knowing how to register a device in China is more and more difficult: finding texts is an mission impossible and even if some information is available, well, it is in Chinese!
And regarding class I radiation-emitting devices of (Attention! The classification is the Chinese one), the going gets though.
However, we did succeed and we managed to find the guideline on class III X-ray devices registration with CFDA, last update in 2016.
This guideline shows how to prepare and elaborate the dossier for such devices, to be submitted to the Chinese Regulatory Authority, and it provides also instructions for a proper documentation review.
The guideline applies to class III X-ray devices for angiography, fluoroscopy and C-arms.
The document is the 2010 Product Registration Guidance of Medical X – ray Diagnostic (Class III) Equipment for Technical Review revised version and the changes included refer to the following eight points:
- the content adjustment to the Notification on publishing the requirements for application documents of Medical Devices and the format of approval documents (CFDA NO.43 of 2014);
- the scope review;
- the introduction of the documents summary to be submitted for registration;
- extension of the requirements for the documentation to be submitted;
- the Technical Guidance for clinical evaluation of Medical Devices requirements adjustment;
- need to carry out on-site clinical trials for interventional devices ;
- introduction of new technical product requirements (including the Chinese standards);
- changes to the classification.
Therefore, if the medical device to be registered in the Chinese market is an X-ray device, the registration procedure is quite complex but it reserves success and satisfaction if you are ready to take up the challenge!
Do you want other information about China? Go to the section Countries China.
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Marisa Testa
QA/RA Manager
