CFDA: CFDA Issues Technical Guideline for Clinical Evaluation of Medical Devices
18. June 2015Certain medical products and devices are required to have CFDA registration prior approval by the CFDA (China Food and Drug Administration Chinese: 国家食品药品监督管理总局) before they can be imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.
China Food and Drug Administration (CFDA) recently issued the latest Technical Guideline for Clinical Evaluation of Medical Devices. The new regulations are applicable to medical devices in Class II and Class III. However, they are not relevant to the clinical evaluation of in vitro diagnostic reagents.
The current technical guidelines of the CFDA are in direct correlation with the recently published working procedures for the examination of quality management systems for the registration of medical devices in China. These working procedures set the formal framework for the application process and system audit procedures for the registration of medical devices.
In an effort to control and increase the safety of medical devices in China, there have been many regulatory restructuring and revisions of the regulations in recent years. It is important that manufacturers stay up to date with the current regulations. Some of the more recent published updates are as follows:
- March 2014 – The CFDA published a completely new version of their “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案)
- July 2014 – The CFDA launched “120 new industry standards for medical devices” (abbreviated as “YY-Standard”).
The purpose for these changes is to promote the positive development of China’s medical equipment industry and to ensure the quality and safety of medical products. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future.
