The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program.

FDA

Regulatory Enrolment Process: Regulatory Background

According to the notice, Health Canada states that the Regulatory Enrolment Process pilot program has successfully met its primary target and has been widely accepted and used by the medical device manufacturer. Thus, the authority decided to expand its initial sphere of application. In particular, the scope of the REP now would also cover private labels. Health Canada actively encourages medical device manufacturers intended to place their devices on the market to use the new regulatory framework. The authority also emphasizes the importance of using the Common Electronic Submission Gateway (CESG) to submit the documents. The use of the CESG, the novel information transmission system, allows us to accelerate all procedures and make them secure and efficient. 

In accordance with the guidelines published by Health Canada, all submissions should be based on the format developed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authorities collaborating to improve the regulatory framework for medical devices. 

In order to assist medical device manufacturers, the authority provides the lists of both acceptable and unacceptable regulatory activities. 

  1. The Regulatory Enrollment Process could be applied in case of:
    1. Class II, III, IV license applications,
    2. Class II, III, IV license applications,
    3. Class II, III, IV minor change amendments,
    4. Class II, III, IV Private Label applications,
    5. Class II, III, IV Private Label amendments.
  2. The Regulatory Enrollment Process could not be applied in case of:
    1. Investigational Testing Application (ITA),
    2. Medical Device Establishment License (MDEL) Applications (e.g. Class I medical devices),
    3. Special Access Program (SAP) Applications.
infusion pumps

REP in Brief

The Regulatory Enrollment Process is based on the collection of the information about the entities involved in operations with medical devices, licenses the hold, regulatory activities and operations, performed with the help of the web-based templates. In comparison to the current approach industry representatives utilize to provide such information is that REP is actually based on the use of extensible markup language (XML) format while now medical device manufacturers submit all aforementioned information in the form of MS Word or PDF files.

In order to apply for participation in the Regulatory Enrollment Process pilot program, the medical device manufacturer shall:

  1. Submit the appropriate request via email. The request shall contain the indication “REP Pilot Medical Devices”.
  2. Supplement the request with the additional information including:
    1. The name of the medical device manufacturer applying for participation,
    2. Contact details,
    3. The number of both existing dossiers and ones the manufacturer intends to submit, and
    4. The number of regulatory activities the manufacturer intends to perform.

Health Canada additionally emphasizes the importance of submitting the appropriate requests within the shortest period of time.

Dossier ID Request Form 

The list of guidance documents and templates published by Health Canada in order to assist medical device manufacturers in applying for and using the Regulatory Enrollment Process pilot program includes, inter alia, the Dossier ID request form for medical devices. According to the template provided by the Canadian medical devices regulating authority, the aforementioned form shall contain:

  1. Dossier Information, including the manufacturer and regulatory company and contact IDs respectively, the indication of the class of the medical device in question in accordance with the risk-based classification, the particular type of the regulatory activity, the number of the license and the name of the device in question in a way it is indicated on the label. This section should also include the indication of the MDSAP Auditing Organization and the license application type. 
  2. In the Primary Contact Information section, the manufacturer shall indicate the name and contact details of the contact person, and also to choose the language for further communications (it could be English or French). 
  3. Alternate Contact Information section intended to be used in a case the manufacturer needs to provide information about additional contact person.

REP Applications Rules

The notification issued by Health Canada describes the consequences of applying for the REP pilot program and also the additional obligations and responsibilities associated thereto. In particular, when applying for participation in the Regulatory Enrollment Process, the medical device manufacturer shall consider the following:

  • In the case that the manufacturer used REP at least once in connection to the particular dossier, all further transactions related to the same dossier should be performed with REP.
  • In the case that the manufacturer used REP at least once, it will have to provide the authority with any additional information only using the REP.
  • Any amendments to the REP Company XML files should be performed exclusively via the CESG. 
  • Any and all transactions related to REP should be performed via the CESG.

It is also important to mention that in order to be able to use the CESG, the company shall have the appropriate account. Thus, the authority encourages medical device manufacturers to apply for account opening as soon, as possible.

EUA eligibility criteria checklist

CESG in Detail

The Common Electronic Submission Gateway constitutes an entirely new approach to the transmission of the documents in the course of regulatory procedures related to the medical devices. The CESG is based on the use of the electronic Common Technical Document (eCTD) format. 

The new system has been implemented by Health Canada to accelerate and simplify the documents exchange between the medical device manufacturer and the authority. It was developed in collaboration with the Food and Drug Administration (FDA), the US medical device regulating authority. 

The medical device manufacturer that intends to use the CESG shall:

  1. Complete the registration as a Trading Partner with the FDA, including the FDA Electronic Submission Gateway (ESG) registration.
  2. Use CESG to send documents to the Canadian authority indicating the “HC” to ensure the documents would be properly redirected to Health Canada. 

The eCTD standard has been initially developed by the International Conference on Harmonisation (ICH) especially to be used in the transmissions related to the regulatory procedures. Wider utilization of the eCTD standard allows to:

  • Submit documents to Health Canada and the FDA simultaneously, which allows associated costs and time needed to be reduced.
  • Reduce costs associated with the delivery of physical documents, including ones transmitted using physical media carriers. 
  • Reduce significantly the paper document flow.

Summarizing the information described hereabove, the new pilot program introduced by Health Canada allows medical device manufacturers to perform all transmissions of the documents required in the course of the regulatory activities in a fast, secure and efficient manner. The new Regulatory Enrollment process program already proved its effectiveness and would be further developed by the authority in the future.

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Sources:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice-expansion-medical-device-rep-via-common-electronic-submissions-gateway.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-electronic-submissions-gateway.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-electronic-submissions-gateway/instructions-benefits-common-electronic-submissions-gateway.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/medical-device-dossier-template.html