China’s CMDE Releases New Rules for Inquiries on Technical Review

In late 2016, the Center for Medical Evaluation (CMDE) of the China Food and Drug Administration (CFDA) released the Guidance for the Management of Inquiry on Medical Technical Review.  This replaces the previous Guidance for the Management of Technical Inquiry on Registration of Medical Devices from 2007.  The CMDE performs “technical reviews” of applications for a new medical device, or for amendments and renewals.  During this process, the applicant is not granted formal meetings with officials, but rather, is allowed to make inquiries regarding their application.  The New Guidance makes the following changes to on-site, online, and telephone inquiries:

  1. The scope of the inquiry is now limited to the specific content of the request for supplemental information, rather than any topic related to the technical review.
  2. The applicant is only allowed three on-site inquiries, limited to thirty minutes. Previously, applicants could ask CMDE representatives unlimited questions during “Open Thursday”.
  3. Online inquiries will be permitted for more simple questions, and will be answered within 20 business days.
  4. The CMDE will release a quarterly FAQs page to provide answers to common onsite, online, and telephone inquiries.
  5. The telephone inquiry process remains largely unchanged. Phone inquiries are permitted from 3:30-4:30 pm Monday and Wednesday.