Special Review Process for Innovation Medical Device

China NMPA published the Special Approval Process for Innovation Medical Device, it is has some changes compare with the pilot edition published at 2014. Below please find my findings thought out the text contrast.

1.       Add IVD Registration Regulation as the reference regulation in item1.

2.    Add two request in item2.1: First is the apply date should be no more than 5 years to patent authority date; another is similar with the prior 4.5.1 but more specific, the published patent should have the Patent Search and Consultation Center’s(part of National Intellectual Property Administration) report to confirm novelty and creativity.

3.       Clarify in item4 that the innovation product application should before the class II and class III first submission process.

4.       Add the item in item6 that Applicant could request for withdraw before the final review decision made with reasons.

5.      Add5 situations to reject with non-expert review:

        a.      Fake files.

        b.    Mess and no logic files

        c.      The content of files obviously in comply withthe apply program.

        d.      The property rights certificate is incomplete and the patent right is not clear

         e.      Prior review has indicated that the product is not first creative in china but no

design change this time.

  6.      Extend the decision time frame from 40 working days to 60 working days(Publicity time is not included.)

  7.       Change the way of notice in item11 that the decision will inform though out the CMDE website, not notice in writing. Meantime, it has 5years valid time, if applicant don’t make submission in 5years, it should re-submit according to this process.

  8.       Delete the prior evaluation request to testing center.

  9.       Add 3 situations in the item22 to stop the process:

            a.     All the core invention patents are rejected or deemed to be withdraw.

            b.     Lost all the core invention patents or the right of using.

            c.      The product is not treated as medical device.

Original version please find below NMPA website.

http://www.nmpa.gov.cn/WS04/CL2138/331560.html

Any problem you want to discuss, please let me know. I will be glad to have a discussion.