Question 1

How does Health Canada classify medical devices?

Accepted Answer

Medical device classification in Canada is determined by Health Canada’s risk-based practice. There are four device classifications, Class I, Class II, Class III, and Class IV. Classification of medical devices dictates the type of license required for your product.

Question 2

Why are medical device regulations important?

Accepted Answer

Medical devices have different classes, and most classes require licensing. To ensure the device’s safety, quality, and efficacy, the Therapeutic Products Directorate (TPD) and more specifically, the Medical Devices Bureau regulates medical devices in Canada by enforcing the Medical Device Regulations.

Question 3

What are the differences between the medical device classes in Canada?

Accepted Answer

Class I medical devices are excluded from requiring a medical device license. But, for Class II, III, and IV medical devices, a license is mandatory before being allowed to sell in Canada. -A thermometer is an example of a class I medical device. Class I devices are low risk whereas Class IV devices are considered high risk.

Question 4

How long does it take for Health Canada to review medical device license applications?

Accepted Answer

Class I:  Do not require a medical device license i.e., Thermometer 
Class II:  These medical devices have a 15-calendar day review time target.
Class III: These medical devices are typically reviewed over the course of 75 days.
Class IV: These medical devices have a time target of 90 days to review.

Question 5

What fee does Health Canada charge for medical device license applications?

Accepted Answer

Health Canada imposes a license application review fee that applies to Class II, III and IV medical devices. The fees will vary depending on the class and whether the device contains human or animal tissue or if the device is for In- Vitro diagnostic use (Class IV). As of April 1, 2022, Health Canada fees start at $522 and increase annually. Once the license is issued, your medical device will be listed on Health Canada’s public website.

Question 6

How can QSS help with Health Canada Medical Device Registration?

Accepted Answer

We have experience serving thousands of medical device companies entering the Canadian market. We will help you.
•	Confirm your medical device classification in Canada.
•	Complete and file MDL or MDEL applications on your behalf.
•	Act as your regulatory correspondent with Health Canada for your device registration.
•	Develop, implement, and modify your quality management system to meet Canadian requirements.
•	Make sure the annual license fee payable to Health Canada is paid on time.
•	Provide on-site auditing to confirm compliance with Health Canada’s medical device regulations.

Question 7

What is the difference between Class I and Class II medical devices?

Accepted Answer

Class I medical devices do not require licensing due to the minimal harm and simple design.  In terms of Class II devices, though they are non-invasive to use they can potentially present a higher degree of danger.  Therefore, these devices need a higher level of quality assurance and must comply with regulations to ensure they won’t cause harm.

Question 8

What are some examples of class III and IV medical devices?

Accepted Answer

-	Pacemakers
-	Defibrilators
-	Implanted prosthetics
-	Cochlear implants

Question 9

What is a class 2 medical device?

Accepted Answer

These devices have a mid-high risk for the user and are the most common type of medical device.  Some examples of these devices include pregnancy tests and powered wheelchairs.

Question 10

What are Class I Medical Devices?

Accepted Answer

Class I medical devices are generally those that pose a low risk to the user and have a simple design. Examples of Class I medical devices include adhesive bandages, hand-held physical therapy equipment, and thermometers. These types of devices do not require FDA premarket approval, but must be in compliance with general controls as outlined by the FDA.

Question 11

What are class II Medical Devices?

Accepted Answer

Class II medical devices are those that pose a little more risk to the user and have more complex design features. These tend to be invasive, such as surgical instruments, wheelchairs, stethoscopes, and pacemakers. As compared with Class I medical devices, these require additional performance testing to ensure safety and effectiveness. Class II medical devices also must be in compliance with general controls as outlined by the FDA as well as special controls specific to the device itself.

Question 12

What are class III Medical Devices?

Accepted Answer

Class III medical devices are considered the highest risk of all medical devices. These typically include implantable devices such as an artificial heart valve, drug-coated stents, and other types of implanted systems. This class is subject to the most stringent premarket approval process by the FDA, which would include a comprehensive; testing and review of safety data, efficacy data, labeling, and/or manufacturing processes. A premarket approval (PMA) is necessary for these types of medical devices and must be obtained before they can be marketed or sold in the US.

Question 13

What are exempt or Non-Classified Medical Devices?

Accepted Answer

Exempt or non-classified devices are also referred to as "over the counter" or "general use" medical devices. These products are generally considered low-risk and are not assigned a particular device class. Examples of exempt devices include bandages, crutches, examination gloves, eyeglasses, thermometers, and tongue depressors. For this type of device, general registration and listing with the FDA are required for its marketing in the United States.

Question 14

What is a 510(k) Clearance?

Accepted Answer

A 510(k) clearance is a premarket notification submission to the FDA when a device is found to have adequate equivalence with legally marketed devices. This type of pre-market submission must be filed by the manufacturer in order for their device to continue its sale or marketing in the US market. Class I devices, and some Class II devices, may require only 510(k) clearance before they can be offered for sale in the US.

Question 15

Which Documents are Needed to Comply With Health Canada Medical Device Regulations?

Accepted Answer

To be compliant with Health Canada Medical Device Regulations, many documents are required. These may include regulatory documentation that outlines the product design and manufacturing process, a list of all components used in the device, risk analysis documentation, software validation documentation, clinical evaluation documentation or a clinical data package, pre-market finish device evaluation forms and reports, labeling information such as labels and instructions for use (IFUs), post-market surveillance programs, change control plans and records, technical file maintenance documents and instructions (such as maintenance logs), etc.

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