2018 Update: Overview of Recent Medical Device Regulatory Changes in China

Product Id : FDA177
Instructor : John Balzano
Dec 12, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Overview

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
Speaker Profile:

John Balzano is a partner in the Food, Drug, and Device group of Covington & Burling LLP, resident in its New York office. John represents companies and trade associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products. He has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the China Food and Drug Administration and other agriculture, animal, and health care products and services. He helps clients develop strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

John also has experience with advising on regulatory compliance and enforcement issues related to China, such as developing global and China-specific compliance procedures, as well as managing China "professional consumer" litigation and inspections, product testing, and regulatory investigations by Chinese authorities.

Prior to joining Covington, John taught Chinese law and transnational litigation at Boston University School of Law. He was also a senior fellow and a lecturer in law at the Paul Tsai China Center at Yale Law School, where he worked with Chinese officials and academics on cooperative projects, primarily in the areas of administrative law and food and drug law and policy.


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