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CFDA: China Focuses on the Registration of Medical Devices

27. March 2017

For the next few years the Chinese government will focus on the development of the market for medical devices. This point was announced as a part of the 13th Five-Year Plan. This year is the first year the five-year plan comes into force with implementation also starting. This may lead to serious changes in the Chinese medical market which will influence CFDA registration.

Chinese manufacturers of medical devices are in a difficult situation. It is estimated that multinational corporations such as GE, Philips and Siemens have approximately 70% of the market share. The market share of Chinese manufacturers of high-quality medical devices is estimated to be only at about 10-20%.

The five-year plan is designed to strengthen domestic manufacturer’s market share. This will also be done though regulatory changes. A large number of foreign manufacturers of high-quality medical devices were required to undergo clinical trials during the registration process. After a long-term review of countless clinical trials, it was determined that up to 80% of the clinical trials were not properly performed or falsified. This has led the CFDA to increase the regulatory requirements for clinical trials. These new requirements protract the registration process and make it much more difficult for foreign manufacturers.
Portrait of two surgeons wearing surgical masks in the operating

The China Food and Drug Administration (CFDA) understands the importance of maintaining an appropriate level of over-sight for the registration process. For this reason, the CFDA has already publicly announced that a more streamlined assessment process is in the works to shorten CFDA registration. The new plan allows manufacturers of Class II products (imported only) and Class III products (domestic and imported) to apply for a “priority review”. However, this is only possible if one of the following three points applies. The product is part of a National Science and Technology Major Project, part of the National Key Research and Development Plan, or it provides significant benefits in the diagnosis or treatment of cancer, geriatric or pediatric diseases.

Despite the changes to the registration process, the Chinese market for medical products offers enormous potential with high growth rates. In order to take advantage of this potential, manufacturers are required to go through the CFDA registration. Due to the changes in regulations, applicants should work with a competent consulting company to save costs and complete the process in a timely manner.

It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. You will find updated information in our news section on our website, where we will keep you informed regarding official announcements.


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MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

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