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.
- Medical devices and in vitro diagnostics: laws and regulations in China, Hong Kong, Japan and Korea.
- Definitions and classification.
- 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.
- 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.
- Culture, people, and sustainable business strategy.
- Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.
- Much more.
Dr David Lim,
President and Principal Consultant,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 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.