The Significance & Importance of Health Canada Licensing Any product that is designed for use on humans requires special Health Canada licensing. Rapid drug screening products are classified as either Class II or III medical devices, and specific regulations and guidelines apply for each license category to ensure patient safety.
Health Canada and the FDA in the United States work closely together to manage the safety and efficacy of all medical devices (ie: rapid POCT devices).
What Constitutes a Medical Device?
According to Canada.ca, “The term “medical device” covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, diagnostic test kits and contraceptive devices.
Medical devices are categorized into four classes based on the level of risk associated with their use. Class I devices present the lowest potential risk (e.g. thermometers) and Class IV devices present the greatest potential risk (e.g. pacemakers).
Based on the classification of POCT devices (Class II or III), Health Canada classifies these devices as having a moderate risk to the patient. Rapid drug testing devices are used as screening tools to determine if a drug(s) is present within the patient’s system in order to implement an effective treatment plan. With no proper health standards in place, the patient can be exposed to a tremendous risk and the test results could potentially harm their well-being. In addition, unlicensed products and companies will NOT have corrective actions or SOP’s in place, which means the safety and effectiveness of the product cannot be guaranteed.
The key objective is to protect the patient and mitigate risk by using a licensed product!
What is a Medical Device Establishment License?
A Medical Device Establishment Licence (MDEL) is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada. An MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance.
All companies that import or sell medical devices in Canada (irrespective of the industry or product use) requires an establishment license.
It is important to note that in addition to the product being licensed, the supplier MUST also be licensed (unless they are a manufacturer). Canadian suppliers are closely monitored and inspected on a regular basis to ensure strict compliance.
What is the Difference Between a Medical Device License and a Medical Device Establishment License?
A Medical Device Establishment Licence is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada. With Health Canada licensing, an MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance. A company that imports or sells medical devices in Canada requires an establishment license.
Performing Due Diligence
Customers should always be aware of companies and products they are working with to ensure proper safety standards are in place. All companies importing and distributing medical devices should possess a valid Medical Device Establishment License (MDEL) and should be listed on the Health Canada site. In addition, rapid screening devices for substance abuse and alcohol should be either a Class II or III device. The following websites may be referenced to perform your due diligence:
www.mdall.ca (for products) and
Why does Health Canada Matter?
According to Canada.ca and the Government of Canada, Health Canada’s role is to help Canadians maintain and improve their health. While the provinces and territories are responsible for delivering healthcare to the majority of Canadians, the federal government also has a number of key roles and responsibilities in areas that affect health and healthcare”2
It is highly recommended that proper due diligence be taken when purchasing these devices, as this could pose a tremendous liability for your organization. The main purpose of maintaining compliance is to ensure patient safety.
Manufacturers and suppliers MUST have standard operating procedures (SOP’s) in place to resolve any issues affecting the patient’s health (as a result of using these devices) and the integrity of the product (e.g. defective product, quality control, product recalls etc…).
Rapid POCT devices are being used to screen patients to ultimately enhance their treatment, so it’s imperative that these devices (and companies selling them) comply with all Health Canada regulations. These regulations are in place to protect the health and safety of Canadians.
We wouldn’t consider using a pharmaceutical drug without FDA or Health Canada approval, so why is a drug test any different?
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