INTERNATIONAL REGULATORY AFFAIRS TRAINING FOR MEDICAL REGISTRATIONS – upon request
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
In this training module, you will learn how to bring medical devices to the international markets for Australia, Brazil, Canada, China, Japan, Korea, Russia, and Singapore.
This training will give an in-depth overview of quality system requirements, device classification, developing regulatory strategy, submission requirements and post market surveillance. This training session does not require any prior knowledge of international medical device regulations and will give you the information required to prepare your first submission to select international markets.
By the end of the training, you will understand regulatory requirements for select regulatory jurisdictions and the relevant quality system requirements. You will also understand how to select and prepare regulatory strategy based on available premarket pathways as well as comprehend submission requirements and processes based on the chosen regulatory strategy and understand the applicable post-market requirements
•Background of regulatory requirements
•Current applicable medical device regulations
•Quality system regulations
•Selecting and preparing regulatory strategy
•Preparing and submitting medical device submissions
- Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF