Health Canada has announced a consultation period for its draft guidance on managing applications for medical device licenses. This guidance is designed to assist manufacturers in navigating the application process while ensuring compliance with regulatory standards.
A key focus of the consultation is to gather feedback on the clarity and content of the draft guidance. Additionally, Health Canada is particularly interested in comments regarding the revamped reconsideration process outlined in the document. The goal is to enhance transparency and streamline the application process for medical device manufacturers.
How can you provide your feedback?
The consultation is open until April 21, and stakeholders are encouraged to provide their input.
Feedback can be submitted here: https://www.canada.ca/en/health-canada/programs/consultation-draft-guidance-managing-applications-medical-device-licences.html
Health Canada values the perspectives of those in the medical device industry and related sectors to ensure the guidance meets practical needs and regulatory expectations.
For manufacturers and industry professionals, this is an excellent opportunity to contribute to shaping the future regulatory landscape for medical devices in Canada.
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