What are medical devices in Canada?

What are medical devices in Canada?

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

What are the different classes of medical devices in Canada?

Medical devices are classified according to Health Canada’s risk-based system. There are four device classifications–Class I, II, III and IV–using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.

How do I get a medical device approved by Health Canada?

Documents must be submitted in English or French. For Class I devices, submit MDEL application, prepare mandatory procedures and pay Health Canada fees. For Class II devices, submit MDL application, Fee Form, labeling (IFU), Declaration of Conformity and ISO 13485 (MDSAP) certificate. Pay Health Canada fees.

What is a Class 1 medical device in Canada?

Classes of Health Canada Certified Products 1. Class I: Low risk devices such as wound care and non-surgically invasive devices. 2. Class II: Low-to-medium risk devices including contact lenses and the majority of surgically invasive devices (e.g., surgical gloves, needles, magnetic resonance imaging equipment).

How do you know if something is a medical device?

To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. Once you have defined the intended use and indications for use of your product, you can determine if the product meets the definition of a medical device.

What is a Class 4 medical device in Canada?

Class IV: High-risk devices such as pacemakers and surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system. The device manufacturer, importer, or distributor is responsible for classifying the device.

Is Dr pen Health Canada approved?

Dr. Pen Canada works directly with the Dr. It is pending approval by Health Canada. As such, Canadian customers may purchase our goods for home and professional use but NOT resale.

What is a Class 3 medical device Canada?

Class III: Medium-to-high risk devices such as hip implants, glucose monitors, ultrasound diagnostic imaging equipment, and surgically invasive devices that are intended to be absorbed into the body or that are intended to remain in the body for at least 30 consecutive days.

What is a Level 2 medical device?

Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.

Is dental floss a medical device?

“FDA classifies medical devices based on the risks associated with the device. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.