target group
Managers and employees of Regulatory Affairs.
content
Entering the Asian market offers enormous opportunities for medical device manufacturers – but not without risk. Knowing and understanding the Asian mentality and the national regulations of the Asian market is essential and can mean the difference between success and failure. The seminar examines the prerequisites and procedures and underpins the theory with case studies and field reports.
topic overview
- Presentation of regulatory requirements for the approval of medical devices in China and Japan
- Quality Management System Requirements / Inspections
- Case studies: Approval of medical devices
- duration and cost
- Field reports / cultural characteristics
previous knowledge
Knowledge of the EU MDR and DIN EN ISO 13485 is recommended.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
