Medical device inspections
Learn about medical device inspections.
On this page
- Who we inspect
- Why we inspect
- How often we inspect
- What happens during an inspection
- What happens after we inspect
- Compliance and enforcement
- Types of inspections
Health Canada routinely and proactively inspects companies that have a Medical Device Establishment Licence for any of the following licensable activities:
- Manufacturing Class I medical devices
- Importing Class I to IV medical devices
- Distributing Class I to IV medical devices
We report the results of these inspections in our Drug and Health Product Information Database.
We also inspect companies reactively, in direct response to reported problems or adverse reactions regarding medical devices.
Other auditing organizations, authorized by Health Canada and other regulators, audit manufacturers of Class II to IV medical devices through a separate program known as the Medical Device Single Audit Program.
This other program is designed so that a single audit meets the quality management system (QMS) requirements of multiple regulatory agencies. The International Organization for Standardization (ISO) 13485:2003 sets the requirements. The results of these audits are not included in the Drug and Health Product Inspection Database because they are not done by Health Canada.
Health Canada reserves the right to inspect any company regardless of the class of medical device they manufacture, import or distribute.
To prioritize proactive inspections we use a risk-based approach when scheduling. This approach looks at several factors, including:
- the number of serious observations in the last inspection
- whether the company has had previous compliance issues
- the classes of medical devices being manufactured, imported or distributed
Reactive inspections, on the other hand, occur as needed, in response to reported problems. We do reactive inspections for all classes of devices. We prioritize reactive inspections based on risk.
An inspector performs many tasks during an inspection, including:
- visiting and inspecting the company's facility
- reviewing medical device labels
- taking samples of medical devices
- interviewing the company's staff members
- reviewing the company's procedures and evaluating if they are being used appropriately
If there is a problem, an inspector:
- describes the problem in a written 'observation' and
- identifies the relevant section of the Food and Drugs Act or its Medical Devices Regulations that has not been followed
In accordance with Health Canada's Risk classification guide for medical device establishment inspections (GUI-0079), we classify observations as a risk 1, 2 or 3, where:
- Risk 1 is likely to cause an immediate or underlying health or safety risk. It could also involve deception, misrepresentation or falsification of medical devices or records.
- Risk 2 could pose a major health or safety risk if uncorrected, but the chance is remote because processes or procedures are in place to reduce the risk.
- Risk 3 has a low or minor risk to health or safety
Observations may be classified at a higher risk level, at the inspector's discretion. For example, if an observation is about a repeated problem, the risk classification may be set higher than shown in the Guide.
After completing an inspection, the inspector writes a report. This contains:
- all the observations made during the inspection
- the risk classification of each individual observation
- an overall inspection rating for the company, as either
- compliant, or
The inspection rating considers:
- the number of observations made
- the risk classification of all the observations
- if there are repeat observations from previous inspections
We share this report with the company so that they can correct the problems. Companies must then give us a written plan on how they:
- have resolved or will resolve the observations noted and
- how they will prevent them from occurring again
The plan must also include target dates for completing the corrective actions.
A compliant inspection rating allows a company to:
- keep their licence and
- continue doing business
It does not mean there were no observations during the inspection.
If a company receives a compliant inspection rating but we have noted observations, we require the company to develop a plan to:
- correct the observations in a timely manner and
- prevent them from occurring again
A non-compliant inspection rating means that, at the time of the inspection, the company's licensable activities did not comply with the Food and Drugs Act and its Medical Devices Regulations.
If a company receives a non-compliant inspection rating, the company's licence may be suspended. A company is not permitted to conduct licensable activities while their licence is suspended.
Before we suspend a company's licence, we may consider the:
- compliance history of the licence holder
- actions taken to correct the observations
- risk to the health or safety of patients, users or other persons
We may not suspend a licence if the observations can be corrected in a suitable way, within a suitable time.
There are 2 types of licence suspensions under the Medical Devices Regulations:
1. We will suspend a company's licence under section 49 of the Medical Devices Regulations if:
- the licence holder has contravened the Regulations or the Act; or
- the licence holder has made a false or misleading statement in their application for a licence; or
- failure to suspend the licence would risk the health or safety of patients, users or other persons
Before a Section 49 Licence Suspension, we issue a company with a 'Proposal to Suspend Notice,' outlining:
- the reasons for the proposed suspension
- any required corrective actions to be taken
- the time in which the actions must be taken
We offer the company an opportunity to respond to this Notice. This gives the company an opportunity to be heard, as required by the Medical Devices Regulations.
2. Under section 50 of the Medical Devices Regulations we will suspend a company's licence immediately to prevent injury to the health or safety of patients, users or other persons.
There is no Proposal to Suspend Notice or opportunity to be heard before a Section 50 Licence Suspension. The suspension letter states the reason for the licence suspension.
If a company's licence is suspended, we will inspect its facility to confirm that the licensable activities have stopped. No further activities may occur until the company:
- has been re-inspected
- receives a compliant inspection rating and
- we have reinstated the company's licence
A licence will be cancelled if it has been suspended for more than 12 months.
Depending on the severity of the problem noted during an inspection, we may take compliance and enforcement actions. These may include:
- issuing a 'stop sale' letter
- requesting a label change
- recalling the medical device
- seizing an unlicensed device
- refusing importation of the device
- controlling the distribution of the device
In the most severe cases, we may:
- suspend or cancel the company's licence
- seek an injunction
- prosecute the company
Any actions we take follow our Compliance and Enforcement Policy (POL-0001).
When deciding what action to take, we consider several factors, including the:
- behaviour of the company, such as whether it acted with indifference, recklessness or premeditation
- company's degree of co-operation and responsiveness
- company's compliance history and previous compliance issues, including their past and recent actions
- likelihood of repeat compliance issues
- likelihood of the enforcement action being effective in bringing the company into compliance or in lessening the risk
We inspect companies both inside and outside of Canada.
Inspections in Canada always take place on site, in person.
Inspections of foreign companies may take place in person, or remotely from Canada. When working remotely we may use video footage, video conferences and telephone interviews to inspect the facility and to interview staff.
Our Drug and Health Products Information Database publishes 5 types of inspections:
- new inspections
- regular inspections
- targeted inspections
A new inspection is the first inspection, to verify if a company's activities comply with the Regulations.
A regular inspection is routinely scheduled after a company has completed their first inspection.
A re-assessment takes place when an inspector decides that a company that received a compliant inspection rating, with observations, needs to be inspected sooner than regularly scheduled.
A re-inspection takes place if a company receives a non-compliant rating during a previous inspection. We focus here on the observations identified during the previous inspection when a non-compliant rating occurred.
A targeted inspection is a non-routine inspection, also known as a 'for cause' inspection. We carry out this type of inspection any time we are concerned that the company might not be following the laws that apply to them.
We can also inspect companies at any time, either in Canada or in foreign countries, in response to reported problems about medical devices. This is known as a compliance verification.
- Guidance Document: Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations
- Drug and Health Products Inspections Database (DHPID)
- How Health Canada inspects medical device establishments (GUI-0064)
- Risk classification guide for medical device establishment inspections (GUI-0079)
- Medical Devices Active Licence Listing (MDALL)
- Medical Devices Establishment Licence Listing (MDELL)
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