Jun 3, 2020

The Health Products and Food Branch (HPFB) of Health Canada announced that it expanded the scope of the Regulatory Enrolment Process (REP) pilot program to include private labels. This news comes on the heels of what the agency describes as a successful initial phase of the pilot that ended on March 31. Health Canada conducted a previous REP pilot for pharmaceuticals and biologics that concluded in July 2019 and led to the decision to begin implementing the program in August of that year.

What is the Regulatory Enrolment Program (REP)?

The REP consists of a set of web-based templates that designed to enable more accurate information collection and automated generation of metadata. It gathers this information from industry utilizing extensible markup language (XML) format, instead of the current practice of using Microsoft Word or PDF forms. Medical device companies are encouraged to take advantage of the opportunity to use the REP and submit their regulatory transactions via the Common Electronic Submissions Gateway (CESG).

The REP can be used for Class II, III, and IV regulatory activities such as Medical Device License (MDL) applications and amendments, minor change amendments, and private label applications and amendments. The REP pilot expansion will be available to companies that are filing regulatory transactions in the IMDRF ToC format.

How can medical device manufacturers join the REP pilot?

Manufacturers who are not already enrolled in the pilot can send an email request to hc.eReview.sc@canada.ca, with the subject heading "REP Pilot Medical Devices."The email must include the following information: manufacturer name, contact information, number of new and/or existing dossier(s) planned, and number of regulatory activities planned.​​ Health Canada will provide further information on how to use the REP to companies once they have been approved for participation. Participants in the pilot are required to make several commitments, one of which is that the REP has been used for a dossier, it must be used for all subsequent transactions involving the same dossier.

Related Health Canada medical device regulatory information from Emergo by UL:

  • Canada emergency use pathways for medical devices and IVDs
  • Health Canada Medical Device License (MDL) registration consulting
  • CMDCAS, MDSAP and Health Canada ISO 13485 quality compliance support
  • Regulatory process chart: Health Canada approval for medical devices

 

Author

  • Timothy Herr

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