Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG)

May 26, 2020
Our file number: 20-107270-785

The Health Products and Food Branch (HPFB) is pleased to announce that the initial phase of the pilot for the medical device Regulatory Enrolment Process (REP) concluded on March 31, 2020. Assessment of the REP pilot was generally positive and users’ indicated a favorable response to the expansion of the REP for medical device regulatory activities.

Effective immediately, the scope of the REP pilot has been expanded to include private labels. HPFB will be encouraging all medical device companies to take advantage of the opportunity to use the REP and submit their regulatory transactions via the Common Electronic Submissions Gateway (CESG). Transactions sent via the CESG are received by HPFB within minutes, using efficient and secure transmission in comparison to the current courier and email processes. Refer to the Common Electronic Submissions Gateway information page on the Health Canada website for further details.

Scope

The use of REP will be available for medical device regulatory activities pursuant to section 32 of the Medical Devices Regulations. All regulatory transactions submitted must be prepared using the International Medical Device Regulators Forum (IMDRF) table of contents (ToC) format. Specifically, REP is available for the following regulatory activity types:

• Class II, III, IV licence applications
• Class II, III, IV licence amendments
• Class II, III, IV minor change amendments [Faxbacks]
• Class II, III, IV Private Label applications
• Class II, III, IV Private Label amendments

Regulatory transactions for the following are currently not accepted as part of REP:

• Investigational Testing Application (ITA)
• Medical Device Establishment Licence (MDEL) Applications (e.g. Class I medical devices)
• Special Access Program (SAP) Applications

What is the REP?

The REP consists of a set of web-based templates used to collect information from industry related to their company, dossiers (licence), regulatory activities and transactions by utilizing extensible markup language (XML) format. Currently, this information is collected using Microsoft Word or PDF forms.

Details on the expanded use of the REP for medical devices

The REP pilot expansion will be available to companies that are filing regulatory transactions in the IMDRF ToC format. Additional information regarding the REP is available on the Regulatory enrolment process information page.

Manufacturers not currently enrolled in the pilot may express their interest by:

• Sending an email to request to participate to hc.eReview.sc@canada.ca, with the subject heading "REP Pilot Medical Devices".
• Providing the following information with the email request:
  • Manufacturer name
  • Contact information
  • Number of new and/or existing dossier(s) planned
  • Number of regulatory activities planned

We encourage manufacturers to submit their requests for participation as soon as possible.

Health Canada will assess requests based on the requirements above. Further instructions on how to use the REP will be provided to all approved participants.

REP Commitments

• Once REP is used for a medical device dossier (licence), all subsequent transactions for that dossier must also use REP.
• If a company has at least one dossier (licence) using REP, all company information must only be provided to Health Canada using the REP Company template.
• The amendments to the REP Company XML files must be sent to, and received from, Health Canada via the CESG.
• All regulatory transactions (< 10 GB) provided using REP (i.e. transactions including a REP XML file) must be sent via the CESG.

Companies without a CESG account who are interested in using REP should obtain one as soon as possible. Please refer to the CESG information page for detailed instructions.

Questions related REP for medical devices should be sent via email to hc.eReview.sc@canada.ca.