Review and approval of medical devices in China: Changes and reform.

Abstract

The 4th US-China Joint Workshop on Regulation, Standards and Innovation of Biomaterials was held during the Annual Meeting of the Society for Biomaterials on April 5, 2017 at Minneapolis, MN. This series of joint workshops have become a unique platform for both the US and China to discuss and update what is new in the field of biomaterials and medical devices in terms of regulation, standards and innovation since 2013. China Food and Drug Administration and its affiliated agencies such as Center for Medical Device Evaluation presented at each of the workshop. With the implementation of Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the People's Republic of China, No. 650) since June 1, 2014, the regulatory changes and reform for medical devices in China have been hot topics in the workshops. This report captures the key information presented during the workshops, which includes major changes of the Chinese medical device regulation systems, reform of the review and approval system for medical devices in China, and the special procedures of review and approval for innovative medical devices. The market growth of medical devices along with demands for innovative technologies brings the ongoing regulatory changes and reform in China, which will certainly create positive impact on both the development of the Chinese healthcare system and the innovation of medical devices in China. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2093-2100, 2018.