4 minute read
DIRECTIONS CANADA
CLINICIAN’S OVERVIEW OF HEALTH CANADA LICENSING REQUIREMENTS
Written by: STEVE CRANNA
The foundation of NRRTS is a commitment to consumer protection concerning Complex Rehab Technology (CRT). Within NRRTS Canada, provider compliance with regulatory requirements has been raised in several conversations across the provinces in recent months.
This article will provide a high-level overview of the primary requirements for our industry from Health Canada, which is similar to the Food and Drug Administration (FDA) in the United States. The overarching mandate of these independent agencies is to protect citizens and ensure and enforce product-specific safety standards. Safety recalls are also overseen by Health Canada when products are deemed unsafe due to potential or actual serious injury to the user or the caregiver.
Two types of Health Canada licenses pertain to our industry sector: one is for the device itself, and the other is for the company distributing the products.
1. Medical Device License (MDL): Health Canada requires all drugs and devices available in Canada to be manufactured and distributed under a license. There are four license classifications. Class I represents the lowest risk (includes wheelchairs, walkers, etc.), and Class IV represents the highest risk products. For example, flotation mattresses – which include any air mattresses – are Class II, and blood pressure monitors are Class III. Class II, III, and IV medical devices must be licensed before they may be imported or sold in Canada.
2. Medical Device Establishment License (MDEL): This license pertains to providers in our industry and will be our focus. It is the most pertinent in that it deals with recalls and provider responsibilities.
Most products such as wheelchairs, walkers and cushions supplied by providers (retailers, under the Act) are Class I and do not require the provider to have an MDEL if they are supplying directly to the end user. However, an MDEL is required by these same retailers of Class I equipment if they sell or rent to entities that are not an end user. For example, sales to hospitals and long-term care facilities,in which multiple patients will use the equipment, require an MDELas the retailer has now become a distributor under the Act. Most providers in Canada are selling to end users and institutions, which necessitates an MDEL.
The primary requirements of MDEL licensing are to have established Standard Operating Procedures (SOPs), which enable product tracking in case of recalls. Furthermore, long-term care facilities and hospitals fall under MDEL standards for the products in use in their locations. The SOPs require the provider to identify all the customers to whom they have provided a specific product, often accomplished through serial number tracking. SOPs are reviewed and approved by Health Canada before granting a license.
The Act reads as follows: Any person who imports a medical device for his/her own personal use retailers, including:
• Companies that sell medical devices to the end user (ultimate consumer or end user) for their own personal use; and
• Canadian manufacturers of Class I medical devices who sell their devices solely to ultimate consumers or end users.
NRRTS expects all NRRTS Registrants to work within their government’s policies. This expectation includes ensuring that their companies have the required insurance and licensing in Canada. In addition, the expectation is that providers are vigilant in ensuring the manufacturers and suppliers they work with also have the required Health Canada licensing.
These expectations demonstrate the industry’s commitment to the safety of our clients and the standards and principles NRRTS expects of its registrants and their respective organizations.
As an NRRTS Registrant or a clinician, you can verify the status of your provider by accessing the easy-to-use lookup to search for license holders at: https://b.link/CAMedDev
Another suggested approach is simply asking your employer/ provider for their MDEL license status or license number. Reputable companies requiring the license will readily provide you with their MDEL number. As professionals, this ensures your patients have the protection provided to them by our Canadian government. It also mitigates any legal exposure in case of a recall.
For details on requirements and processes, you may refer to the Guidance Documents provided by Health Canada at: https://b.link/MedDevApp
CONTACT THE AUTHOR Steve may be reached at STEVE.CRANNA@VGM.COM
Steve Cranna is the director of new business development and government relations at VGM Group Services.
