Execution of a sound regulatory strategy is paramount to the successful development and commercialization of a medical device. The regulatory requirements that drive strategies are predicated on risk-based device classification schemes.
The lecture component of this session will provide participants with an understanding of the medical device regulations, in key markets, as they pertain to medical device classification and the corresponding regulatory requirements and pathways to market authorization. Real-world examples will be discussed, demonstrating the processes to classify various devices in Canada, United States and the European Union. An overview of regulatory strategy development will be provided along with a tool kit to assist entrepreneurs to compile the critical regulatory and market information that informs the decision of initial target market for their proposed product.
The workshop component will provide participants with an opportunity to practice classification of a medical device (tangible or fictitious – examples will be provided) in international jurisdictions, and to explore the available resources to inform a regulatory strategy. Exercises will employ tools and templates that will be provided to participants for use during the sessions and for future reference.
1) Understand the impact of risk-based medical device classification on regulatory requirements
2) Apply tools and resources to appropriately classify a medical device in key regulatory jurisdictions
3) Recognize the critical elements of a regulatory strategy
4) Understand the processes and data sources for developing a regulatory strategy