About medical device inspections
Before medical devices can be sold to Canadians, they must meet high safety and quality standards. Learn about medical devices and how we inspect and license the companies that make them.
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Medical device inspections
These inspections allow us to find problems and prevent them from becoming serious safety risks.
Companies are required to:
- correct safety and quality problems
- keep detailed records so unsafe products can be:
- traced anywhere in Canada
- taken off the market
What are medical devices?
Medical devices are used to diagnose, treat, manage or prevent disease or other health conditions.
They are grouped into 4 classes depending on the risk associated with their use.
- Class I devices present the lowest potential risk, for example:
- Class II devices present the next higher level of potential risk, for example:
- hearing aids
- Class III devices present a further level of potential risk, for example:
- hip implants
- diabetic test strips
- blood pressure monitors
- Class IV devices present the greatest potential risk, for example:
- HIV test kits
Which types of companies are inspected and licensed by Canada?
Canada licenses and inspects 3 types of medical device companies, including:
- licenses and inspects:
- manufacturers of Class I devices
- importers and distributors of all classes of medical devices
- licenses Class II, III and IV medical devices before they can be sold in Canada
- independent medical device auditors inspect the device manufacturers to ensure they meet quality standards
How often are inspections conducted?
The frequency of a medical device inspection is based on the company's activity. Companies engaged in the type of activity that has the highest risk (manufacturing) are inspected more often.
Inspections are conducted every:
- 3 years for manufacturers
- 4 years for importers
- 5 years for distributors
We may also conduct inspections at any time in response to reported problems and complaints in Canada or abroad.
What inspectors look for
Inspectors review a company's records and procedures. They may:
- interview personnel
- tour the company's site
- take samples of medical devices
Inspectors make "observations" when they see areas where companies are not meeting the standards set out in the:
- Food and Drugs Act
- Medical Devices Regulations
Observations may address areas such as:
- record keeping
- storage facilities
- advertising claims
- written procedures
- labels and packaging
- handling of complaints
- reporting of problems and recalls
Observations include those that:
- do not pose a safety risk
- could pose a safety risk if uncorrected
- pose an immediate or potentially serious safety risk, in which case:
- a non-compliant rating is issued
- immediate measures are taken
Medical device inspections for foreign sites
About 30% of Canada's medical device licence holders are based outside the country. We inspect foreign companies that distribute medical devices to help ensure they meet our high safety and quality standards.
Inspections of foreign sites are generally conducted:
- by e-mail
- offsite by:
- virtual tours
- video conferences
In foreign site inspections:
- companies fill out detailed questionnaires
- inspectors review their records and written procedures for compliance with Canada's Food and Drugs Act and Medical Devices Regulations
After a medical device inspection
After completing an inspection, the inspector writes an inspection report and issues an overall rating to the company. This overall rating is classified as either compliant or non-compliant.
A compliant rating means a company is complying with the Food and Drugs Act and Medical Devices Regulations.
It is common for a company to receive a compliant rating even if observations have been identified.
Companies may be required to take corrective actions.
A non-compliant rating means that:
- a company is not complying with the Food and Drugs Act and Medical Devices Regulations
- observations have been made that could lead to immediate or potentially serious health risks to Canadians
Companies could be required to take immediate corrective measures. We may:
- suspend or terminate a company's licence in some cases
- issue recalls, public advisories and border restrictions or stop sales, if needed
Where possible, companies are given the opportunity to correct observations during an inspection. However, we always take appropriate action when a risk to health and safety is identified.
Companies must provide us with a written corrective action plan for any observations identified, including target dates for completion.
We may conduct a follow-up inspection to make sure the corrective actions have been taken.
Inspection report cards
Canada posts detailed report cards for medical device inspections:
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