How do you classify a medical device in Canada?

The rules for non-IVDD medical devices can be grouped into four sets:

1. Invasive Devices (Rules 1 – 3)
2. Non-invasive Devices (Rules 4 – 7)
3. Active Devices (Rules 8 – 12)
4. Special Rules (Rules 13 – 16)

What is a Class 1 medical device Canada?

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).

What is the difference between a Class II and Class III medical device?

Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What is a Class 3 device?

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

What is the classification of medical devices?

Class I Devices – Non-evasive,everyday devices or equipment.

Class Im Devices – This refers chiefly to similarly low-risk measuring devices.

Class IIa Devices – Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term.

Why to classify your medical device for the FDA?

The FDA’s medical device classifications range from Class I to Class III depending on a device’s intended use and risk level. Knowing your planned device’s classification from the get-go is incredibly important. That’s because it will determine the resources and regulatory controls required to safely and successfully take it to market.

What are FDA regulations for medical devices?

Medical Device Regulations in the USA. In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.

What are the regulations for medical devices?

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies.