September 13, 2019 @ 11:00 AM – 12:00 PM
LIVE Online Seminar (LIVE Webinar)
Global Compliance Seminar
731-Go to GCS (468-6427)

LIVE Online Seminar

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

  • Date:  September 13, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes


About the Seminar

This webinar is intended to help you identify and get familiar with the regulatory requirements for medical devices including in vitro diagnostics (IVDs) in Asian countries, China, Hong Kong, Japan and Korea.  In particular, we will discuss current medical device laws and regulations in these countries.

The medical devices are currently one of the fastest growing industries. The current knowledge and 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.

This webinar will greatly help you understand and accurately interpret applicable laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.

This webinar will further help you facilitate and expedite the registration process for your medical devices including IVDs in these Asian countries.

The speaker will present the regulatory requirements for medical devices in a CAC-SI manner.  *: CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the regulatory requirements in these four Asian countries, helping you save significant amount of your time, efforts and resources.

About the Areas to Be Discussed

  1. Medical devices and in vitro diagnostics: laws and regulations in China, Hong Kong, Japan and Korea.
  2. Definitions and classification.
  3. Regulatory framework for medical devices in China, Hong Kong, Japan and Korea.
  4. Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea.
  5. How to identify and address the regulatory requirements.
  6. How to establish and maintain systematic methods to meet the regulatory requirements.
  7. How to streamline the regulatory process.
  8. Culture, people, and sustainable business strategy.
  9. Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.
  10. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. Dr. Lim also developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $249 


Error! You must specify a price for your product in the shortcode.

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

Medical Device Laws and Regulations in Asian Countries