On May 7th this year, China National Drug Administration (CNDA) released a proposed draft of special review and approval procedure for innovative medical devices. The procedure intends to expedite approval for medical devices if the Applicant has patents or patent applications pending in China. This draft contains several major revisions compared with the previous version issued in 2014.
Highlights of revisions are as follows:
1） the revised measures add in vitro diagnostic medical devices;
2) the measures limit eligibility to only Category II and Category III devices from previously Category I – III devices;
3) the CNDA adds the following requirements to the core technology related patents:3-1) for a granted patent, its application date (or the priority date) shall be within 5 years from applying for the innovative medical device approval procedure, while the previous version does not have any time limit;
3-2) for a published patent application, the Applicant should provide a search report issued by the Patent Search and Consultation Center of the State Intellectual Property Office (SIPO) indicating the core technology of the products has novelty and inventiveness, while previously the Applicant could submit a novelty assessment report issued by a domestic searching agency recognized by the Ministry of Science & Technology;
4) the CNDA increases the term of reviewing eligibility to participate in expedited review by adding 20 additional working days (60 in total);
5) the Applicant will now receive review results online instead of by mail;
6) the Applicant must complete the regulatory review process within three years of receiving approval from the CNDA to participate in the expedited approval program;
7) the CNDA adds the following three situations that can terminate the application process:
7-1) when the invention patent application of the core technology is rejected or deemed withdrawn;
7-2) when the Applicant loses its ownership or right to use the core technology invention patent;
7-3) when the product applied for is no longer considered a medical device which belongs to Category II or Category III (e.g., downgraded to Category I);
The above proposed revisions focus on optimizing the current procedure and facilitating the approval process for innovative medical devices. If there are no additional changes due to suggestions coming from the public, the above revised procedure will come into force on October 1, 2018.