2014 - Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea

Instructor: David Lim
Description:
This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.
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, which necessitates the integration of regulatory schemes available and applicable in various regions of the world to best develop a practical, actionable and sustainable regulatory plan and strategy. For many reasons, Asian medical device markets are highly attractive. Thus, it is imperative we get familiar with currently applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process.
In this webinar, the speaker will discuss the updated differences in regulatory frameworks (regulatory requirements and compliance) in Asia, intending to help you understand and accurately interpret applicable laws and regulations governing medical devices in China, Hong Kong, Japan and Korea. This webinar will help you expedite the registration process for your devices in these Asian countries.
Speaker will present laws and regulations governing medical devices in China, Hong Kong, Japan and Korea. It 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.
Objectives of the Presentation:
Updated medical device laws and regulations in China, Hong Kong, Japan and Korea.
Definitions
Device classification and rules
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.
Regulatory requirements for medical devices in China, Hong Kona, Japan and Korea
How to establish and maintain systematic methods to meet the regulatory requirements.
How to streamline the regulatory process.
Speaker's suggestions for best practices in a PASS-IT manner
Conclusion
Who can Benefit:
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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