Health Canada has recently launched a significant update to streamline the submission process for medical devices. The Medical Devices Directorate (MDD) is now offering the Regulatory Enrolment Process (REP) as a voluntary option to stakeholders involved in medical device applications. This development marks an important step towards creating a unified submission intake method across different product lines and filing formats.
Purpose and Scope
The purpose of this update is to inform stakeholders about the availability of the Regulatory Enrolment Process (REP) for medical devices. The REP aims to simplify the submission process by introducing web-based templates that replace the various current Medical Device Licence (MDL) application forms. These templates standardize how information is captured, allowing for a more efficient submission process and automated integration into Health Canada’s internal systems.
What Are the Changes?
The REP is available for the following activities related to Class II, III, and IV medical devices:
The following activities are not included in the REP:
Health Canada has announced that the voluntary phase of the REP for medical devices will continue for the next 18 months, starting from July 2024. Following this period, the REP will become mandatory for all in-scope MDL submissions. At that time, the use of the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format will also become mandatory for all regulatory submissions.
How Can I Be Prepared?
To ensure your readiness for this transition, stakeholders are encouraged to adopt the REP for all upcoming MDL submissions. This proactive approach will help familiarize your team with the new format and process before its mandatory implementation.
Stay informed by regularly checking the Regulatory Enrolment Process (REP) Main Page for updates and guidance.
Get Expert Advice
At dicentra, we’re here to help you navigate these regulatory changes with ease. Our team of experts is ready to provide tailored compliance strategies and support to ensure your medical device submissions meet the new REP requirements. Don’t hesitate to reach out to us for assistance in preparing your applications or to learn more about how these changes could impact your regulatory strategy.
For further questions regarding the REP, please contact Health Canada directly at devicelicensing-homologationinstruments@hc-sc.gc.ca.
Together, we can streamline your path to compliance and make the transition to the Regulatory Enrolment Process as seamless as possible.