ComplianceOnline

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

Instructor: David Lim 
Product ID: 702841
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

Why Should You Attend:

The medical devices are currently one of the fastest growing industries. The knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and 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 streamline the regulatory process. To do so, we should understand differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

This 90-minute training will discuss medical device laws and regulations in China, Hong Kong, Japan and Korea. It is intended to guide you through to understand and accurately interpret applicable laws and regulations governing medical devices in the above Asian countries. The presenter will guide participants from the medical device industry to streamline their business planning and regulatory strategy in these global markets.

Areas Covered in the Webinar:

  • Medical device laws and regulations in China, Hong Kong, Japan and Korea.
  • Definitions
  • Regulatory framework for medical devices in China, Hong Kong, Japan and Korea.
  • Device classification
  • Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea.
  • How to identify and meet 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, through (PASS-IT) manner.

Who will Benefit:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Marketing (associates, specialists, managers, directors and VPs)
  • Site managers, and consultants
  • Contract manufacturing organization (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors

Instructor Profile:

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters.

Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, Dr. Lim has completed two years in law school.

Dr. Lim is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.

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