Medical device inspections

Learn about medical device inspections.

On this page

• Who we inspect
• Why we inspect
• How often we inspect
• Types of inspections
• What happens during an inspection
• What happens after we inspect
• Compliance and enforcement

Who we inspect

Health Canada routinely and proactively inspects companies that have a medical device establishment licence (MDEL) for:

• manufacturing Class I medical devices
• importing Class I to IV medical devices
• distributing Class I to IV medical devices

We may also inspect companies that do not have an MDEL but are subject to the Food and Drugs Act (act) and its Medical Devices Regulations (regulations).

We report the results of these inspections in our Drug and Health Products Inspections Database.

Other auditing organizations, authorized by Health Canada and other regulators, audit manufacturers of Class II to IV medical devices through a separate program:

• Medical Device Single Audit Program

The results of these audits are not included in the database because they are not done by Health Canada.

Why we inspect

We inspect companies that manufacture, import or distribute medical devices for sale in Canada to make sure that they comply with the act and its regulations.

How often we inspect

We schedule inspections of companies in Canada using a risk-based approach. For this approach, we look at factors such as compliance history and medical device classification.

Types of inspections

We inspect companies both inside (domestic) and outside (foreign) of Canada.

Inspections may take place onsite or remotely. When working remotely, we inspect the facility and interview staff using video footage, video conferences and telephone interviews.

We publish 5 types of inspections on our database:

• new inspections
• regular inspections
• re-assessments
• re-inspections
• targeted inspections

Learn more about these inspection types and the inspection process:

• How Health Canada inspects medical device establishments (GUI-0064)

What happens during an inspection

An inspector performs many tasks during an inspection. These include:

• visiting and inspecting the facility
• reviewing medical device labels
• taking samples of medical devices
• interviewing the company's staff members
• reviewing the company's procedures to see if they are being used appropriately

The inspector will bring any non-compliance to the act or its regulations to the attention of the company's representatives. They will also request the corrective actions that need to be taken.

What happens after we inspect

After completing an inspection, the inspector writes a report. It contains:

• all the observations made during the inspection
• the relevant sections of the act or its regulations that have not been followed
• the risk classification of each individual observation
• an overall inspection rating for the company:
• compliant or
• non-compliant

The inspector bases their findings on the Risk Classification guide for medical device establishment inspections (GUI-0079).

Companies must respond to the final inspection report by sending us a written plan describing:

• how they have resolved or will resolve the observations noted
• how they will prevent them from occurring again and
• when they will complete the corrective actions

Compliant rating

At the time of the inspection, the company demonstrated that the activities it conducts are in compliance with the act and its regulations. It does not mean there were no observations noted during the inspection.

Non-compliant rating

At the time of the inspection, the company's licensable activities do not comply with the act and its regulations.

If a company receives a non-compliant rating, its MDEL may be suspended. A company may not conduct licensable activities while their MDEL is suspended.

For more guidance on the suspension process, consult:

• Guidance on medical device establishment licensing (GUI-0016)

Compliance and enforcement

Depending on the severity of the problems noted during an inspection, we may take compliance and enforcement actions. For example, we may:

• issue a stop sale letter
• request a label change
• recall the medical device
• seize an unlicensed device
• refuse importation of the device
• control the distribution of the device

In the most severe cases, we may:

• suspend or cancel the company's MDEL
• seek an injunction
• prosecute the company

Any actions we take follow our compliance and enforcement policy for health products (POL-0001).

Related links

• Guidance document: Requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations
• Medical Devices Active Licence Listing (MDALL)
• Medical Devices Establishment Licence Listing (MDELL)
• Food and Drugs Act
• Medical Devices Regulations