Thanks again to Rob Packard for providing another guest post. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs. 

Thank you for reading my previous posting on Creo Quality, “FDA 510(k) or CE Marking?” from July 10^th. As an encore performance, I am writing this posting to explain the process for obtaining a Canadian Medical Device License. Why?

Because Canada is easier to obtain approval from than the US FDA or European Notified Bodies.

For my example, I have chosen to invent a client for Jon to help.

Jon just got a call from the makers of Krazy Glue^®. They want 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, Jon’s 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. Jon’s client indicates that they want to sell cyanoacrylate as a medical device all over the world. Therefore, Jon does a little homework and decides that a “topical adhesive” application will give his client the higher margins of a medical device for prescription use, but it will also avoid the costly pre-market approval (PMA) process at the FDA. Jon also decides to recommend that his client try a pilot launch in Canada first to evaluate their new packaging ideas on a smaller market than the USA or Europe.

My first job in Regulatory Affairs taught me the most valuable lesson of all: “Always go back to the source.” In this case, Jon doesn’t want to rely only this posting for his information on how to get a Medical Device License in Canada. He needs to start with the Regulations. The “helpful links” (http://13485cert.com/helpful-links/) page of my website tells you how 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://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf. The Regulations were most recently updated on June 27, 2012. 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://13485cert.com/did-canada-forget-about-document-control/). The posting is 762 words long, but the two-word answer is: “Not much.”

Now that Jon has the single greatest cure for insomnia, he skips 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 this device, but how does Jon know?

Type: Single Device
Device Class: 2
First Issue Date: 2012-02-27
Licence Name: SURGISEAL TOPICAL SKIN ADHESIVE

Now that Jon has verified this is a Class 2 device in Canada, Jon needs to review the Canadian Licensing Process. In the  CMDR, starting on page 16 (Section 32), Jon reviews the process of applying for a Medical Device License. He also reviews the Guidance Document for “How to complete a new medical device license application.” The location of the Health Canada Guidance Document is: http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_licapp_im_ld_demhom-eng.php. Fortunately, this is a Class II device and the requirements are primarily to complete the application form and to 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 phthalate content of the device in the application. However, this tissue adhesive would only have phthalates if it was contained in the packaging.

After Jon’s review, he meets with the client to explain the next steps of the process:

1. The client needs to upgrade their existing ISO 9001:2008 Quality Management Certificate to an ISO 13485:2003 Certificate with CMDCAS. “CMDCAS” is the Canadian Medical Device Conformity Assessment System. 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.

2. Jon and the client need to revise the labeling to meet the requirements for Sections 21-23 of the CMDR. Since this product will be used by Medial Professionals, rather than an over-the-counter product, the labeling requirements are similar to Europe and the US. 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.

3. The client will need Jon to conduct an internal audit to the CMDR requirements prior to the certification upgrade audit.

4. Finally, once the new Quality System Certificate is received Jon and the client can complete the application and submit the application with a copy of the new certificate.

In all, Jon estimates that his client can complete this process in 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 decides to combine the two audits to save money on the travel costs and to give themselves a little more time to prepare.

Not all applications are this easy. For higher risk devices (i.e. – Class 3 and 4), summary technical documentation (STED) must be submitted in paper and electronically. 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 documentation matches the requirements for Technical Files required by Europe for CE Marking and 510(k) submissions required by the US FDA. However, the documentation can be prepared for most devices in less than 6 months—including biocompatibility testing and sterilization validation. This can also be done in parallel with obtaining ISO 13485:2003 certification. The only item that might require longer is if Clinical Studies are required—which is only required for high-risk devices or novel devices that are dissimilar from other devices already on the market.