Content
The ASEAN countries are among the most important markets in medical technology. However, before medical devices can be legally distributed, manufacturers must demonstrate compliance with legal regulations. In this seminar, participants will learn which requirements must be met in the respective countries in order for medical devices to be approved by the responsible authorities there. You will learn how to proceed to successfully create the necessary documentation for registration.
Topic overview
- Regulatory requirements compared to Europe
- Documents to be submitted
- Competent authorities and representation in the country
- Necessary quality management systems
- Process and case studies
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
