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Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada, under the Canadian Medical Devices Assessment System (CMDCAS).
The level of regulatory scrutiny to be applied is based on risk management principles that use a rule-based system to classify medical devices into four classes, with Class I representing the lowest risk and Class IV the highest. Here are some examples of devices relating to product classification.


Description

CE Classification

adhesive strip

I

amalgam alloy

III

aneurysm clips

IV

angiographic system X-ray

III

angioplastic coronary laser

IV

breast implants

IV

cerebral blood flow monitor

IV

daily wear, soft contact lenses

II

disposable surgical instruments

II

electroanesthesia apparatus

III

endoscopic still camera

I

external, pacemaker, pulse generator

IV

fetal blood sampling endoscope and accessories

IV

fetal ph monitors

IV

fiberoptic illuminator for an endoscope

I

high energy DC defibrillator

III

hysteroscopic insufflator

II

infusion pump

III

intraoral dental light

I

intrauterine contraceptive device

III

laryngoscope

II

latex condoms

II

manual, adjustable, hospital bed

I

oropharyngeal airway (anaesthesiology)

I

orthodontic brackets

II

peritoneal, long term indwelling catheters

III

piston syringe

II

short term, intravascular catheters

II

steam sterilizer

II

surgical microscope system

I

surgical or dental instruments

I

tissue heart valve

IV

tracheal stent

III

tympanoscope

I

volume ventilator (critical care)

III

More examples…



If any of these examples is equal or similar to your type of products, take note of its classification and click on the “Tell us what you need” button and let us do the work for you.
 
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