Notice: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices
September 5, 2018
Our file number: 18-110311-854
In December 2018, Health Canada will start piloting REP using the CESG for Medical Device applications.
The REP helps industry provide information related to their company and licence applications to Health Canada, in advance of the regulatory review process. By using a collection of web-based templates to capture information in a structured XML format, Health Canada can receive the information via the CESG, partially populate internal systems ahead of time, and automate certain procedures when an application is received.
This Regulatory Enrolment Process is currently being piloted by Health Canada for other product types . The objective of REP is to implement a common intake approach while expanding the scope of the CESG to accept more transactions in various formats. Once fully implemented, the REP will reengineer existing administrative processes to take advantage of the tools and capabilities of an electronic processing and review environment. It will introduce a consistent approach to collecting high quality information across multiple regulatory activity types.
The CESG provides manufacturers the ability to send regulatory transactions electronically to Health Canada in a secure manner, with reduced transmission times and cost. It has been in operation at Health Canada since February 2014, for a subset of regulatory activities . Subsequently, the scope of regulatory activities accepted via the CESG will continue to expand to include more product lines in various formats. Refer to the Frequently Asked Questions – Common Electronic Submission Gateway (CESG FAQ) document.
REP Functional Pilot for medical device applications in electronic Table of ContentFootnote * (ToC) format
- Intent: To assess the feasibility of providing information related to company, licence (dossier), and regulatory transaction using REP and to test the use of the CESG for medical devices.
- Target duration for Phase I: December 2018 to May 2019.
- Scope: All Class III and IV New and Amendment applications, in ToC format, pursuant to section 32 of the Medical Devices Regulations
Comments regarding this notice can be sent to hc.eReview.firstname.lastname@example.org
- Footnote *
In efforts to stay aligned with other leading regulatory authorities, Health Canada is implementing the International Medical Device Regulators Forum (IMDRF) Table of Content (ToC) format as the preferred format when submitting Medical Device applications for both In Vitro Diagnostic Devices (IVDDs) and non-IVDDs as of April 1st 2019.
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