Canada Health has a similar process as the European Union. But they have an additional step to follow as well as another term you need to know.
The four steps of their process include:
Determine if your medical device is non-invasive, invasive, active, or special.
Find out what your class is. (Guidance on the Risk-based Classification System for Non-Invitro Diagnostic Devices)
Class II or higher medical devices have to become part of the MDSAP (Medical Device Single Audit Program)
Determine your path to market.
You know what non-invasive, invasive, and active mean. But what about special?
Special: a special device is any device that is used for disinfecting or sterilizing blood, organs, or tissues for transfusions, as well as other medical devices—such as autoclaves or ultraviolet sterilizers.
Once you have defined what type your medical device is, visit the links and follow the directions included on those pages for steps 2 and 3.
Determining your path to market in step 4 is the same as it was for the EU and the FDA.You'll need to visit the links above and follow the instructions on those pages to complete steps 3 and 4.
After you've completed steps 1–4, you can then tackle step 5 and create your plan for bringing your medical device to market.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
