How Do You Know Home Medical Equipment Is Certified?

Medical devices can earn certification as long as they satisfy the guidelines set out by the relevant regulatory agencies. For example, in the United States, producers and distributors of medical devices are generally required to register every year with the Food and Drug Administration (FDA).

In Canada, Health Canada reviews medical devices to assess their safety, effectiveness, and quality before being authorized for sale in Canada. They maintain a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. In the United States, Devices@FDA is a catalogue of approved and cleared medical device information from the FDA.

In Canada, the Classes that require registration are Class II through IV. Class I medical devices do not require a medical device license:

• Class II medical devices are those devices that have a moderate to high risk to the patient or user.
• Class III medical devices sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury. Examples include glucose monitors, hemodialysis systems, and breast implants.
• Class IV medical devices are high-risk devices such as pacemakers and surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system.

In the United States, there are three classes, with regulations increasing up the scale.

• Class I devices are those, according to the FDA, that are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”
• Class II devices are those “for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”
• Class III devices are those that “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.”