2018 Update: Overview of Recent Medical Device Regulatory Changes in China
Instructor : John Balzano
Dec 12, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes
China has started another round of substantial changes to medical device regulation over the past year, creating a more efficient system for companies to develop and market their products in China. This includes a new regime for the acceptance of foreign data to support medical device marketing applications, a proposal for an expanded system of clinical trial exemptions, and new regulations on post-market surveillance.
Why Should You Attend:
China’s medical device regulatory environment has been particularly dynamic and fluid over the last four years. China completely revised its device regulatory regime in 2014 and is now preparing to make potentially equally significant changes in the coming year or two. Continuously monitoring for new opportunities and challenges is important, particularly at a time when the regulatory regime is increasingly complex and enforcement against devices on the market is becoming more stringent.
This webinar will provide an overview of the past, present and future of medical device regulation in China. In particular, it will discuss the groundbreaking reforms that China’s government passed in October 2017 and the progress and prospects for implementation of those reforms. It will cover certain core changes in depth and provide insight as to what stakeholders should monitor for in the future.
Areas Covered in the Session:
- Summary of the device regulatory environment in China to date
- Overview of new policy changes issued in October 2017 and implementation progress to date
- Key changes in the proposed Medical Device Supervision and Administration Regulation
- New guidance documents on the acceptance of foreign data
- New post-marketing surveillance regulations, including on recalls and adverse event reporting
- Important upcoming reforms (e.g., registration agent reforms, unique.
Who Will Benefit:
- Regulatory Professionals
- Quality Professinals
- Regulatory lawyers
- Small Business Owners
- GxP Consultants
- FDA and International Regulators