In Asia, not understanding or failing to comply with various regulatory requirements can severely inhibit your ability to conduct business. Conversely, rapid registration and regulatory approval will give you a significant competitive advantage.
Given that for medical device, the key areas for business growth and opportunity are primarily in Asia. As such, commercial and regulatory staff must have a good understanding of the regulatory environment in each market to ensure efficient product launch and regulatory compliance.
This seminar will provide students with a deep understanding of the regulatory landscape for each area discussed as well as a broad awareness of the developing trends and project that may influence regulations in the future.
Learning objectives
Introduction to GHTF and AHWP
- What are the key global and regional regulatory organizations in play.
- What trends are developing
Update on AHWP and ASEAN
Introduction to regulatory requirements for Hong Kong, Singapore, Malaysia, Thailand, Taiwan, Korea and Japan
Gain an in-depth understanding of the regulatory process in India
Update on China including a project management discussion
- Key challenges of registration in China
Course materials
Students will receive reference materials.
Who should attend
- Staff concerned with product regulations
- Corporate officers concerned with company compliance to regulatory requirements
- Commercial staff required to understand the environment in which they are selling
Prerequisite
There is no formal prerequisite for this course.
