Global Regulatory Pulse

CFDA Announces “Administrative Measures on Communication with Applicants for the Technical Evaluation of Medical Device (Trial)”

In Asian Market, Regulatory by Dr. Jiechen Yin

Background
Oftentimes, during the process of medical device registration, applicants need to consult with reviewers at the Center of Medical Device Evaluation (CMDE), a branch of the Chinese Food & Drug Administration (CFDA), to discuss the technical review of application materials.

Earlier this year, the CFDA announced the release of the “Administrative Measures on Communication with Applicants for the Examination of Medical Device (Trial),” which outlines new requirements for communication with the CMDE. In an effort to assist Chinese medical device manufacturers to better understand these updated practices and guidelines, the CMDE has provided various ways to speak with Chinese government officials. These include:

I. Technical Questions
For general technical questions, applicants can approach the CMDE reviewers via phone, email, mail, fax and the CMDE online consultation system. To get in touch with a specific reviewer, you may visit http://www.cmde.org.cn/CL0017/to locate a reviewer’s contact information. (The telephone consultation service is open every Monday and Wednesday afternoon from 15:30 to 16:30.)

II. Online Consultation System
Medical device registration applicants may also use the online system to ask questions (visit: http://www.cmde.org.cn/schedule_zx/login.jsp). For general questions, CMDE reviewers may provide answers online; for more in-depth questions, a phone call may be required by the reviewer. If face-to-face communication is necessary, the reviewer will reach out directly to the applicant to secure a meeting.

In order to utilize the online system, an application number is required, allowing access only to manufacturers who have successfully submitted their case.

It is also important to note that CMDE’s previous “Open Day On-Site Consultation Service” has been discontinued. Alternatively, Thursdays are now open for face-to-face consultations for applicants with appointments only. 

III.  Communication Session
Typically, a communication session with CMDE reviewers and other attendees (per applicant request) can be arranged by CMDE under the following circumstances:

1. Before a submission of an innovative medical device, the following topics may be discussed during a review meeting:

  • Major technical issues
  • Significant security issues
  • Clinical trial protocol
  • Summary and evaluation of the results of clinical trials when achieving a significant milestone
  • Other issues that require communication
  1. Organizations submitting information for an innovative medical device or a medical device that is eligible for priority approval and are under technical review, may arrange a communication session. These sessions will focus on, and discuss, any issues regarding supplementary submission.

All registration applicants that require communication sessions must submit their application to the CMDE directly. The detailed procedure can be found by visiting: http://www.sda.gov.cn/WS01/CL0087/169361.html.

Summary
The new CMDE administrative measure will provide more options for medical device manufacturers to communicate directly with the CMDE. This is especially true for innovative medical devices and medical devices that are eligible for priority approval. However, for manufacturers who have not submitted communication applications, but require a consultation, there may be limitations. Nevertheless, other communication methods are available via phone and email.

These recent efforts further demonstrate the CFDA’s commitment to encouraging innovation and product development within China’s medical device industry.

Did You Know?
NAMSA has dedicated regulatory experts in China that are ready to discuss your potential medical device development efforts, including your registration strategy, to help identify the most efficient product pathway for your device. NAMSA’s regulatory expertise, coupled with our recently-opened preclinical research laboratory in Shanghai, is providing clients with significant time and cost savings throughout all stages of the development process.

If you’d like to discuss your medical device development project, please contact us at communication@namsa.com. We also invite you to watch the unique, fun video created for our Shanghai lab opening here.

Authors:

Dr. Jiechen Yin joined NAMSA China in June 2016 as Medical Writer, responsible for composing Clinical Evaluation Reports (CERs) and other essential documents. Dr. Yin has 8 years of R&D experience in the field of medical device in academia, and worked as a Collaboration Scientist and Product Manager in Siemens Healthcare. She received her Ph.D. degree in Biomedical Engineering from University of California, Irvine.