CFDA promulgated Provisions on the Administration of Instruction for Use and Labels of Medical Devices (NO. 6 Order of CFDA) on 30 July 2014. The provisions were adopted at the 27 June 2014 CFDA meeting, and took effect 1 October 2014.
To help management representatives and regulatory professionals better understand labeling and Instructions for Use (IFU) in China, the presenter will provide an overview through the following three parts: 1) labeling and IFU relating to the risk of use; 2) China’s provision of labeling and IFU; and 3) implementation of labeling and IFU.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Upon the webcast's conclusion, you will:
- Learn the risks of use for medical devices and the role of labelling and IFU
- Understand the new China provisions on labeling and IFU
- Be familiar with the key issues related to the implementation of labeling and IFU
Who should attend
- Regulatory professionals
- Management representatives
Liang Yan, president of the Shanghai Pudong Medical Device Trade Association; vice president of Medical Devices Industry Association; senior consultant of policy & regulations and international cooperation in Institute of Food and Drug Safety of Shanghai Food and Drug Administration
Yan was the director of medical device registration and director of legal affairs and international affairs of the Shanghai Food and Drug Administration until 2009. He has been engaged in government administrative work for more than 35 years, focusing on pharmaceutical and medical device industry management and administrative regulations. In 2006, Yan used the unique device identifier concept to organize a first pilot project of the implantable medical device traceability system in Shanghai 120 hospitals.