CFDA Announces 186 New Industry Standards for Medical Products
20. May 2016Certain medical products and devices are required to have 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 sold or used in China. In an effort to insure continued safety and effectiveness of medical products, there have been several changes and revisions within the Chinese regulatory framework for CFDA certification.
In March of 2014 the CFDA published a new version of the “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案). In its announcement No. 25 and No. 74 of 2016 the CFDA introduced 186 new Industry Standards (abbreviated as “YY Standards”). These industry standards are split in 42 mandatory and 144 recommended standards. However, recommended changes are often a precursor to future mandatory changes to come. Compliance with these new recommended “YY” standards is highly recommended since they may become mandatory at any time with very short notice.
The new standards apply to the following products:
- Implants for surgery
- Disinfection equipment
- Medical extracorporeal circulation equipment
- Dental equipment
- Ophthalmic equipment
The purpose for these changes is to promote further improvement of China’s medical device standards system, and build a solid foundation for ensuring the safety and effectiveness of medical devices. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future.
