Obtaining a Health Canada Medical Device License (Case Study)
This article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device Licensing is generally a more straightforward process than the 510(k) submission process for the US FDA and the European CE Marking Process. Therefore, launching a new product in Canada is one of the fastest ways for start-up medical device companies to achieve initial cash flow.
For this case study, I chose the maker of Krazy Glue® as a hypothetical new client. The company wants to start selling their products as medical devices. Fortunately for them, companies have been selling cyanoacrylate (e.g., – Krazy Glue®) as a medical device for years. Therefore, my client needs to decide if they want to sell the product as 1) a liquid bandage, 2) a topical adhesive to replace sutures, or 3) a vascular repair device for use inside the body during surgery. The client indicates that they want to sell cyanoacrylate as a medical device all over the world. Therefore, after a little homework, the client decided that a “topical adhesive” application will give the company higher margins of a medical device for prescription use. Still, it will also avoid the costly Pre-Market Approval (PMA) process at the FDA. I recommend that the client try a pilot launch in Canada first to evaluate their new packaging ideas on a smaller market than the USA or Europe.
Even though I have submitted multiple-device license applications to Canada, my first job in Regulatory Affairs taught me the most valuable lesson of all: “Always check the source.” Therefore, I went to the “helpful links” (http://bit.ly/RA-Resources) page of my website to find the Canadian Medical Device Regulations (CMDR), but for those of you that just don’t want to work that hard, here’s the direct link: http://bit.ly/SOR-98-282. The CMDR was most recently updated on December 8, 2014, but there have been no amendments to the regulations since December 16, 2011. If you want to know what the difference is between the current version and the previous version, I wrote an entire blog posting on just that topic (http://bit.ly/CMDRChange). The posting is 701 words long, but the two-word answer is: “Not much.”
Once I find the most recent version of the CMDR, I skip ahead to the bottom of page 54. Rule 4 states that “all non-invasive devices that are intended to come into contact with injured skin are classified as Class 2.” This is the applicable rule for a topical adhesive, but with device classifications, I always verify the Classification by looking up the license for a competitor product. The competitor product I selected was “Surgiseal.” I wasn’t sure who the manufacturer was for Surgiseal™, so I used Health Canada’s Medical Device Active License Database and searched by “Device Name.” In this case, I quickly found the license information I needed. Still, sometimes I use the US FDA website’s Registration and Listing Database (http://bit.ly/CDRH-Registration-Listing-Database) to identify device names and the name of manufacturers. The Canadian Device License information for Surgiseal™ is shown below:
After verifying, this is a Class 2 device in Canada, I reviewed the Canadian Licensing Process for Class 2 devices. Starting on page 16 of the CMDR, Section 32, I reviewed the process of applying for a Medical Device License. I also reviewed the Guidance Document for “How to complete a new medical device license application.” The location of that Health Canada Guidance Document is http://bit.ly/Canadian-Device-License. Fortunately, this is a Class 2 device, and the requirements are primarily to complete the application form for a new Class 2 device license (http://bit.ly/Canadian-Device-License-Form), sign attestations regarding compliance with the safety and effectiveness requirements (Section 10-20 of the CMDR) and compliance with the labeling requirements (Section 21-23 of the CMDR). The application form has a new section requiring information about the phthalate content of the device in the application. However, this tissue adhesive would only have phthalates if it was contained in the packaging.
Obtaining a Health Canada Medical Device License: The Process
After reviewing all the requirements for a device license application, I meet with the client to explain the next steps of the process:
- The client needs to upgrade its existing ISO 9001:2008 Quality Management Certificate to an ISO 13485:2003 Certificate with CMDCAS. “CMDCAS” is the Canadian Medical Device Conformity Assessment System (http://bit.ly/CMDCAS-Certification-Part2). The Quality System Auditor from the registrar will look for additional requirements specific to the CMDR, but all of these requirements are identified in GD210—another guidance document from Health Canada. This will only require a one-day external audit to upgrade the scope of the current certification.
- The labeling needs to be revised to meet the requirements for Sections 21-23 of the CMDR. Since this product will be used by Medical Professionals, rather than an over-the-counter product, the labeling requirements are similar to Europe and the U.S. The most important thing to do will be to implement the use of appropriate symbols found in ISO 15223:2012—an Internal Standard for Labeling and Symbols.
- The client will need to conduct an internal audit to the CMDR requirements before the certification upgrade audit. If I make revisions to the client’s quality system, then another auditor on my team will conduct the internal audit remotely. If the client makes the changes to the quality system themselves, then I can conduct the internal audit myself.
- Finally, once the new CMDCAS Quality System Certificate is received, we can complete the medical device license application and submit the application with a copy of the new certificate.
In my proposal to the client, I estimate that the entire process will require less than 60 days. When the client gets an upgrade quotation from their registrar, the earliest date available is in 10 weeks, but their annual surveillance audit is already scheduled for 13 weeks. Therefore, the client decided to combine the upgrade audit and the annual surveillance audit to save money on the travel costs and to give themselves more time to prepare for the upgrade to CMDCAS certification.
Not all applications are this easy. For higher-risk devices (i.e., Class 3 and 4), Summary Technical Documentation (STED) must be submitted in both paper and electronically. Health Canada provides guidance documents for this, and there is a Global Harmonization Task Force (GHTF) document that explains how to prepare these documents. Depending upon the Classification and complexity of the device being submitted, this documentation can take weeks or months to prepare.
The STED documents described above meet the European CE Marking requirements for the content of a Technical File, and most of the STED documents can be modified to meet 510(k) submission requirements of the US FDA. Preparation of STED documents, including STEDs for biocompatibility testing and sterilization validation, can be prepared in parallel with obtaining ISO 13485:2003 certification. The only item that should require additional time is the clinical summary–if clinical studies are required.
If your company needs help with Canadian Medical Device Licensing, please contact Rob Packard.
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