E-Submissions for registration in China

China is step by step implementing an E-submission approach. As of 2019-11-01 applications submitted to NMPA shall be submitted according to the “Technical Guideline on Registration Material Requirements for Electronic Submission System”. (see our News Blog "NMPA published the "Technical Guidance for Submission under the RPS ToC")

NMPA as member of the IMDRF prepared this guidance for the e-RPS based on the IMDRF nIVD(MA)ToC.

This does not necessarily mean that the applications now need to be submitted through the online portal e-RPS without submitting any paperwork but he may also follow the second option to at least organise the documents in a way following the e-RPS structure  and submit the paperwork together with a memory stick to NMPA.