Let’s assume a medical device company wants to get into the Canadian Market to meet the requirements of many of its customers. But they are not aware of Canadian regulations for medical device manufacturers and importers that they need to meet to bring their product in the market.
Here, in this article, we will discuss the following –
⦿ Primary objectives of a medical device company
⦿ How Elexes helped the medical device company to meet medical device regulations in Canada?
● Prerequisite 1 : Medical Device Single Audit Program (MDSAP)
● Prerequisite 2 : Medical Device License (MDL)
● Prerequisite 3 : Medical Device Establishment License (MDEL)
● Quality System
● Production Documentation
● Clinical Trials
● Submissions
● Final Outcome
Primary Objectives
The primary objectives of the medical device company in discussion is 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
How Elexes helped the medical device company to meet medical device regulations in Canada?
With the thorough knowledge and experience of Health Canada Regulations, Elexes’ team guided the Client and helped them understand the 3 primary applicable prerequisites required to enter and legally sell medical devices in the Canadian Market.
These 3 prerequisites are part of Canadian medical device regulations that every company wishing to market their product in Canada.
Prerequisite 1 : Medical Device Single Audit Program (MDSAP)
MDSAP is a single audit program for medical devices, which fulfills the regulatory requirements to bring your product to market in multiple countries including US, Canada, Japan, Australia, and Brazil. It helps demonstrate compliance with the QMS requirements to receive Health Canada approval.
As per the Canadian medical device regulations, all the Class II, III, and IV devices can add the MDSAP certificate audit to their current audit program to launch their product in Canada.
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.
Prerequisite 2 : Medical Device License (MDL)
An MDL application is the manufacturing license or approval license issued by Health Canada to sell Class II, III, and IV medical devices as per the Canadian medical device regulations.
The MDL application is required to be submitted in accordance with the IMDRF TOC format. As per the requirements, for Class II devices, documentations include –
● MDL application form
● Fee Form
● Declaration of conformity
● ISO 13485 (MDSAP) certificate
● Labeling documents
For Class III and IV, the documents required are –
● MDL application form
● Fee Form
● Declaration of conformity
● ISO 13485 (MDSAP) certificate
● Labeling documents
● Premarket review documents
● Clinical & non-clinical evidence
Prerequisite 3 : Medical Device Establishment License (MDEL)
Medical Device Establishment License (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 according to Canadian medical device regulations.
Unless a device is exempted under section 44 of the Medical Devices Regulations in Canada, it is mandatory for medical device manufacturers to 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 required to be submitted for an applicable type of MDEL application are:
● Applicant information
● Activities information
● Sites information
● Manufacturer, supplier information, and attestations.
Types of MDEL Applications
According to the Medical device regulations in Canada, the following are the differnt types of applications you must know about –
New MDEL Applications
This is a type of submission that is applicable when you are applying for the first MDEL or are applying for a new MDEL after the cancellation of the previous one.
Amendment
This application is sought if there are any modifications to the information on an existing 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 addres
● Change in the details of the representative such as name, title, and/or telephone number
Cancellation
As per the Canadian medical device regulations, 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
● In case MDEL has been suspended for more than 12 months.
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
This is required when after the suspension of MDEL by Health Canada, the application is sought if the manufacturers want to resume importing, selling, and/or manufacturing medical devices.
We, at Elexes made the medical device manufacturer aware of the complete process, cost and timeline involved in MDEL
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
Final 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 as per the Canadian medical device regulations.
● 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.
