Program Description

This suite of courses provides learners with a country by country overview of the regulatory and ethics requirements to start, conduct and close pre and post market medical device clinical investigations. Each course will cover:  

• the country specific regulations and how to implement the national requirements for medical device clinical investigations
• resources such as notification forms, which are provided
• the ethics requirements in a given country
• the timelines involved in the regulatory and ethics committee submissions with details about common pitfalls
• the fees involved
• other applicable requirements where needed including insurance
• ongoing reporting requirements during the clinical investigation including safety reporting
• Data protection requirements
• How to close down prematurely or at study completion including reporting needed and archiving requirements.

This suite will be completed with country requirements from around the world with the addition of at least 1 nation per month. Participating experts have committed to providing updates where needed.

Upon completion of a country specific course , learners will be able to:

• perform regulatory submissions to start clinical investigations with medical devices or provide the necessary documents for third parties to perform the submission on their behalf
• ensure the necessary documents are available to put together a notification to the ethics committees and make the submission, depending on the learner’s role
• ensure compliance with national requirements on ongoing reporting during clinical investigations
• ensure compliance with national requirements to prematurely terminate or close a clinical investigation upon completion.