A medical device company wanted to get into the Canadian Market to meet the requirements of many of its customers. However, they were unsure of how to begin this journey and what should be done to achieve authorization to sell legally within Canada.

Primary objectives:

The primary objectives of the medical device company were to:

• Ensure they understand the regulations of the Canadian Market
• Make sure the efforts are not redundant and the work done prior can be put to use
• Analyze which license might be applicable to bring in their products
• Understand the timeline and cost of approval

Knowhow offered by Elexes:

With its thorough knowledge and experience of Health Canada Regulations, Elexes guided the Client and helped them understand the 3 primary prerequisites, as applicable, to be able to enter and legally sell medical devices in the Canadian Market:

Prerequisite 1 — Medical Device Single Audit Program (MDSAP)

• MDSAP is a single audit program for medical devices, which fulfills the regulatory requirements of major countries like the US, Canada, Japan, Australia, and Brazil.
• Manufacturers of Class II, III, and IV devices except for the manufacturers of Class I devices, can add the MDSAP certificate audit to their current audit program.
• MDSAP helps demonstrate compliance with the QMS requirements to receive Health Canada approval.

Prerequisite 2 — Medical Device License (MDL)

• An MDL application is a manufacturing license or an approval license issued by Health Canada to sell Class II, III, or IV devices in Canada.
• An MDL application must be submitted in accordance with the IMDRF TOC format.
• The contents of submissions are dependent on the device classification.
• For Class II devices the required documentation is the MDL application form, fee form, declaration of conformity, ISO 13485 (MDSAP) certificate, and labeling.
• For Class III and IV devices, the required documentation is the MDL application form, fee form, declaration of conformity, ISO 13485 (MDSAP) certificate, labeling, and premarket review documents including clinical and non-clinical evidence.

Prerequisite 3 — Medical Device Establishment License (MDEL)

• MDEL is an authorization or permits issued by Health Canada to Class I medical device manufacturers and other Class device importers/distributors to market their devices in Canada.
• Unless exempted under section 44 of the Medical Devices Regulations, medical device manufacturers must maintain and apply for a Medical Device Establishment License (MDEL) in order to import or sell any Class of medical devices in Canada.
• The essential information to be submitted for an applicable type of MDEL application is the applicant information, activities, sites, manufacturer and supplier information, and attestations.

Types of MDEL Applications

New MDEL Application:

This type of submission is applicable in the following cases:

• Applying for the first MDEL
• Applying for a new MDEL after a cancellation of a previous MDEL

Notification:

This type of notification must be delivered to Health Canada within 15 calendar days and it is applicable when any of the following occur after the issuing of an MDEL:

• Change in establishment name and/or address
• Change in the details of the representative such as name, title, and/or telephone number

Cancellation:

In the event that you are no longer carrying out any activities covered by an MDEL, this form of submission is appropriate. In addition, Health Canada has the following grounds for revoking a license:

• Failure to submit an annual license review application by the 1st of April of each calendar year, or
• In case MDEL has been suspended for more than 12 months.

Amendment:

• This application is sought if there are any modifications to the information on an existing MDEL.

Reinstatement:

• After the suspension of MDEL by Health Canada, this application is sought if the manufacturers want to resume importing, selling, and/or manufacturing medical devices.
• Elexes made the medical device company aware of the overall process flow, cost and timeline involved

After making the Client understand the prerequisites and helping choose the best application to be pursued, Elexes continued to help the Medical Device Company by supporting quality systems, product documentation, clinical studies, and finally regulatory approval.

Quality Systems

Elexes conducted a gap assessment of the medical device company’s current quality systems and identified gaps with respect to MDSAP. Elexes assisted in addressing each of the gaps and some deliverables involved in this process were as follows:

• Roles undertaken by an organization — with respect to Class II devices that are not subject to Design and Development controls, verify whether the manufacturer has objective evidence to establish that devices meet the safety and effectiveness requirement
• Risk, sequence and interaction — identify whether the manufacturer has a process or procedure for identifying a “significant change”
• Evaluation of document and record control process

Product Documentation

Elexes patiently reviewed all the documents that the medical device company already had in place, tried to leverage and reduced redundant work. Additionally, Elexes Team helped the Client create or update:

• Labeling documents
• Revised user manual to include the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device since the specifications, are necessary for proper use
• Created shipping labels
• Ensured UDI requirements were met
• Updated storage conditions
• Design History File (DHF) which consisted of, but not limited to the following:
• Risk management file
• Usability engineering file
• Validation protocols and reports
• Performance test reports

Clinical trials

Elexes first assessed the product technology and as a result identified a need for clinical trials. Elexes facilitated a Pre‐Investigational Testing Authorization application meeting with Health Canada to present relevant data and to discuss concerns and issues regarding product development. The following were prepared to organize the Pre‐ITA application meeting.

• Synopsis of proposed study
• Set of preliminary questions
• Information package with following details;
• Device specifications, preclinical testing which includes the results of bench tests and animal studies
• Details on standards used in the design and manufacture of the device
• Details of the proposed clinical investigation

Submission

After clarifying with Health Canada, Elexes started the review and preparation of the entire submission application and associated requirements for the submission such as:

• Device description
• Indications for use
• Design Philosophy
• Marketing History
• Risk Assessment
• Results of bench testing and pre‐clinical studies
• Alternate Treatments

Outcome:

• The Client was able to understand the different prerequisites in order to launch their devices into the Canadian market and was audited for MDSAP and received the certification, which made it easier to showcase their compliance with the QMS requirements.
• The Medical Device Company could conduct their clinical trials within Canada and submit the report detailing the data analysis together with statistics and a critical appraisal of the aims of the investigation.
• With Elexes’ commitment and consistent efforts, the Client was able to achieve approval from Health Canada and make their products available to interested customers.

A wrong regulatory step for your device classification, application type, and testing will be detrimental to your company, both in terms of time and money. Elexes has a well-experienced team capable of providing timely inputs for different Medical device submissions and approvals. Contact Elexes to avoid missteps in your regulatory submissions.

Please feel free to contact us at jennifer@elexes.com or call +1 408–475–8091 for further details.

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