Global Regulatory Pulse

CFDA Issues Announcement on Medical Device Priority Approval Procedures

In Asian Market, Regulatory by Dr. Jiechen Yin

On October 26, 2016, the China Food and Drug Administration (CFDA) issued an announcement on the priority approval procedure for medical devices to help further optimize examination and approval procedures, and to help meet increased clinical demands. This guidance will take effect on January 1, 2017.

Background
Prior to October’s announcement, the CFDA issued a “Special Examination and Approval of Innovative Medical Devices (Trial)” in February of 2014, which established special testing and approval procedures for innovative medical devices.

Following, in March, 2014, the State Council released a revised “Medical Device Supervision and Management Regulations” document, which encouraged medical device research and innovation, and discussed the importance of letting “the market mechanism play its role in order to promote the development and application of new medical devices, and to drive the development of the medical device industry.”

And, in 2016, the General Office of the State Council circulated the “Notice on Key Tasks in 2016 on Deepening Healthcare System Reform,” further encouraging research and innovation by providing special procedures for the testing and approval of medical devices that meet urgent clinical needs for rare diseases specific to special populations (children, elderly).

These announcements not only demonstrate the CFDA’s encouragement of innovation and development within the medical device industry, but also its commitment to providing guidance to assist in the growing need for devices, and support of industrial development.

Scope of Application
The most recent guidance on medical device priority approval procedures (October, 2016), outlines the following:

Domestic Class III, and imported Class II and Class III medical devices, that meet one of the criteria below, are eligible for applying for priority approval through the CFDA:

I. Medical devices that meet one of the following conditions:

  • Diagnosis or treatment of rare diseases, and has obvious clinical advantages
  • Diagnosis or treatment of malignant tumors, and has obvious clinical advantages
  • Diagnosis or treatment of diseases specific to, and frequently occurring in, the elderly population, where there are no other available effective diagnosis or treatment
  • Dedicated to children, and has obvious clinical advantages
  • To meet urgent clinical needs, and where there are no same species of products approved for registration in China

II. Medical devices in the National Science and Technology Major Project, or in National Key Research and Development Program

III. Other medical devices that should be given priority approval. (The CFDA will gather opinions and comments, and an organized experts committee to determine whether the devices are eligible for entering the priority approval procedure.)

Priority Approval Procedure
For medical devices listed in the National Science and Technology Major Project, or National Key Research and Development Program (criteria 2), the applicant shall submit relevant supporting documents. After examination and announcement by the CFDA’s Center for Medical Device Evaluation (CMDE), the priority shall be given. CMDE shall start an evaluation procedure within five business days once the device is qualified.

For devices that fall into criteria 1 and 3, the CMDE will organize monthly expert review meetings to determine whether the devices are eligible. If there are no objections during this process, priority shall be given. If a device is determined unqualified for the priority procedure, it will be evaluated as an ordinary device, and follow the standard procedure. Devices that enter the priority approval procedure will be evaluated separately from other devices by CMDE, chronologically.

For further information regarding the recent priority approval procedures announcement, please click 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.