2008 ASEAN Medical Device Harmonization Trends
Regulatory harmonization, post-marketing surveillance schemes, and a Common Submission Dossier Template are just some of the new plans the Association of Southeast Asian Nations (ASEAN) has been working on recently. Are you aware of the newest regulations and trends in Southeast Asia? Though some of these nations' medical device regulations have been minimal or nonexistent in the past, increased ASEAN medical device regulation and rapid change are now underway. ASEAN includes Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.
What you will learn:
- Country Overview
- Overview of ASEAN
- Key Indicators
- Priority Sectors
- What is ACCSQ?
- What is ACCSQ MDPWG? ASEAN Medical Device RegulationRegime
- Formation of MDPWG
- Structure of MDPWG
- Current Status
- Technical Documentation -- Common Submission Dossier Template
- Development of CSDT
- Implementation of CSDT
- Status of Implementation
- Development of ASEAN Medical Devices Directive
- Purpose of Directive
- Timeline for Implementation of Directive
- Adoption of GHTF Documentation
- Classification of Devices
- ASEAN Medical Device Industry Association
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on ASEAN medical device issues.
This webcast CD includes the audio and PowerPoint presentation.