On-demand Webcast: CFDA Registration Requirement for Imported Class II&III Medical Devices

With the implementation of Provisions for Medical Device Registration on 31 October 2014, there were lots of changes for CFDA registration requirements related to medical devices, especially with treating domestic and imported medical devices equally. The newly added request compared to the previous regulation put imported medical devices in a more challenging position. This webcast will help foreign establishment get prepared through the learning of the overall China regulation framework for imported medical devices and provide a detailed introduction of CFDA registration process, requirement and potential cost.

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: 

  • Deliver the overall CFDA registration process and timeline
  • Provide a guideline for CFDA registration documentation preparation for multiple types (new, change, extension registration)
  • Understand the concept of CFDA registration requirement for imported medical devices in China

Who Should Attend

  • Regulatory affairs specialists in charge of imported MD CFDA registration
  • Decision maker who needs to know the overall CFDA registration timeline and budget planning
  • Those interested in CFDA registration requirements for imported MD

Speaker

Elva Shang, regulatory affairs manager, Siemens Greater China

Elva Shang is the regulatory affairs manager of Siemens Greater China and has more than 10 years experience with CFDA registration and regulatory strategy planning for multiple imported and domestic medical devices. Shang has a masters degree for pharmaceuticals and Regulatory Affairs Certification (US/Global/EU/CAN).