Canadian Medical Device Regulation 101
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Canadian Medical Device Regulations 101
Speed the research ethics board (REB) review process by understanding how medical devices are classified and what the REB must review to confirm a device’s regulatory status.
What Is a Medical Device?
A medical device is an instrument, apparatus, contrivance, or other similar article, or an in vitro reagent, including a component, part, or accessory of any of them, that is manufactured, sold or represented for use in:
(a) Diagnosing, treating, mitigating, or preventing a disease, disorder, or abnormal physical state, or any of their symptoms, in human beings or animals
(b) Restoring, modifying, or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
(c) Diagnosing pregnancy in human beings or animals
(d) Caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring
(e) Preventing conception in human beings or animals
However, it does not include such an instrument, apparatus, contrivance, or article, or a component, part or accessory of any of them, that does any of the actions referred to in [the list above] solely by pharmacological, immunological, or metabolic means or solely by chemical means in or on the body of a human being or animal.
Section 2 of the Canadian Food and Drugs Act
REB Review of Device Studies
Ineligible for marketing in Canada (i.e., cannot be sold):
|Regulatory designation||Investigational testing authorization (ITA)|
|Designation explanation||Health Canada determined the research proposed in the ITA application can proceed
Required for research involving Classes II, III, and IV devices
|Typical risk||Intermediate to high|
|REB required actions||Confirm that an ITA has been or will be obtained before the research will begin|
Eligible for marketing in Canada (i.e., can be sold):
|Regulatory designation||Class I||Licensed (approved)|
|Designation explanation||Product category is within the lowest
risk classification ITA not required for Class I devices
|Health Canada reviewed a medical device license (MDL) application and approved it*|
|Typical risk||Low||Intermediate||Intermediate to high||High|
|Example||Prescription sunglasses||Blood reinfusion bags||Orthopedic implants||Implantable pacemakers|
|REB||Confirm that the device is Class I||Confirm the device as used in the study is being used according to its licensed use|
*This application process is similar to the FDA 510(k) for intermediate-risk and intermediate to high-risk devices, and similar to the FDA pre-market approval (PMA) for high-risk devices.
Devices in the Marketplace
Characteristics by Class
Class I: Low-risk devices
Class II: Intermediate-risk devices
Class III: Intermediate-risk to high-risk devices
Class IV: High-risk devices
Note: Health Canada provides 16 rules to assist in determining a device’s classification. For details, see Health Canada Guidance on the Risk-Based Classification System for Non-In Vitro Diagnostic Devices (Non-IVDDs).