On-demand Webcast: China Regulations on Medical Devices: Adverse Event Monitoring and Re-evaluation

When the Medical Device Regulation in China was updated in June 2014 it included the regulatory requirements for the monitoring of adverse event and recall of medical device. In addition, CFDA also updated the provisions for the handling of medical device adverse event.

The regulatory requirements for reporting of adverse event and recall of medical device are different from other countries. Under the new regulation, CFDA will perform a more strict post-market surveillance than before. This webcast will provide you with new regulatory requirements and help you establish internal procedures.

Learning Level:

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.

Learning Objectives 

  • Upon the webcast’s conclusion, you will be able to:
  • Know the regulatory requirements for reporting and recall
  • Become familiar with the specific definition in China
  • Understand procedures for reporting and recall

Who Should Attend

  • RA managers
  • RA specialists

Speaker

Xiaoming Hong, president, Mid-Link Technology Testing Co., Ltd

Xiaoming Hong is dedicated in providing regulatory services for medical device firms, including premarket applications, quality systems, compliance, trainings and tests, which helps the products access to market in a speed manner and ensure the compliance during the whole product life cycle. Hong has also been involved in working with various government agencies to provide professional opinions. She is also the invited to be the guest professor of China Food and Drug Administration Institution of Execute Development, which is held directly by CFDA. Her professional job has been complimented by not only the industry but also by authorities.