Content
Entering the Asian market offers enormous opportunities for medical device manufacturers - but not without risk. India in particular, which is now the most populous country in the world, offers interesting potential. Knowing and understanding the diverse Asian mentalities as well as the national regulations of the different markets is essential and can make the difference between success and failure. Participants learn how to proceed to successfully create the necessary documentation for registration. During the seminar, the requirements and procedure are examined and the theory is supported with case studies and experience reports.
Topic overview
- Presentation of regulatory requirements for the approval of medical devices in Taiwan, Hong Kong and India
- Responsible authorities and representations in the country
- Documents to be submitted
- Quality management system/inspection requirements
- Process and case studies
- Experience reports/cultural peculiarities
- Duration and costs
target group
Managing Director and Employee Regulatory Affairs.
Prior knowledge
Knowledge of the EU MDR and DIN EN ISO 13485 is recommended.
Notice
Participation in the seminar “Fundamentals of Regulatory Affairs International” is recommended in advance.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
