CFDA: CFDA Issues Measures for Unannounced Inspection of Drugs and Medical Devices
3. August 2015Certain medical products and devices are required to have CFDA registration 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.
The CFDA has recently issued the Measures for Unannounced Inspection of Drugs and Medical Devices, which will take effect on September 1, 2015. The measures comprises of 35 articles in five chapters, including the general provisions, initiating, inspection, handling and supplementary provisions. The measures provide that development, production, operation and the processing of drugs and medical devices are included in the scope of unannounced inspections.
The goal of these inspections is to make sure that manufacturers stay up to date with the current regulations and to promote the positive development of China’s medical equipment industry, ensuring the quality and safety of medical products.
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”).
- 2015 – The CFDA introduced another 90 industry standards (you can find more information on these in our news section).
It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the near future. In our “News section” on our website, we will keep you informed regarding the official announcements and changes to these regulations.
Please do not hesitate to call (UK: +44 2071931135, US: +1 773 654-2673) or email with any questions you may have.
