The European Union has a much simpler process than the FDA does, and it only includes three steps.
Determine if your medical device is non-invasive, invasive, or active.
Find out what regulations your medical device has to follow and what class it is.
Determine your path to market.
In step one, you need to determine if your medical device is non-invasive, invasive, or active. Let's define what each of these means, so you know which one your device is.
Non-Invasive: your device doesn't penetrate the body through any surface or orifice.
Invasive: your device penetrates the body completely or partially through any surface or orifice.
Active: your device relies on a source of energy not generated by the human body to work.
Once you know which one of these your medical device falls under, you can visit the link in step 2 to find out what class your device is. The last step is where you put all the information together then come up with your plan for getting the device to market.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
