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.
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.
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
Course Provider
David Lim,
