Medical Device Laws and Regulations in Asia – China, India, Japan and Korea

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, India, 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, India, 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, India, 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.

Areas Covered in the Session :

• Updated medical device laws and regulations in China, India, Japan and Korea.
• Definitions, Device classification and rules
• Regulatory framework for medical devices in China, India, Japan and Korea.
• Regulatory requirements for medical devices including in vitro diagnostic devices in China, India, 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.
• PASS-IT Recommendations: Best Practices
• Interactive Q&A session

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

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. 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 eight 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 pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.