Medical Device Laws and Regulations in Asian Countries: China, Hong Kong, Japan and Korea

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Comprehend The Laws And Regulations Governing Medical Devices In China, Hong Kong, Japan And Korea

The medical devices are currently one of the fastest growing industries. The current knowledge, accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market.  Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in Asian medical device markets, it is necessary to get familiar with applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process.  To do so, we should understand the differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

Join Dr. David Lim in this 60 minute audio session, where he will shed light on the laws and regulations governing medical devices in China, Hong Kong, Japan and Korea. This session is designed to help medical device industry implement practical, actionable and sustainable strategy for device registration in these countries and further to streamline their business planning and registration process in Asian countries.

David will help you get familiar with medical device laws and regulations, and help you understand and expedite the registration process for your devices in these Asian countries:  China, Hong Kong, Japan, and Korea.

Session Highlights

  • Laws and regulations governing medical devices in China, Hong Kong, Japan and Korea
  • Definitions and classification
  • Regulatory framework for medical devices in China, Hong Kong, Japan and Korea
  • Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea
  • How to identify and address the regulatory requirements
  • How to establish and maintain systematic methods to meet the regulatory requirements
  • How to streamline the regulatory process
  • Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, thorough (PASS-IT) manner

Clear your doubts at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Who should attend?

  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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