How Health Canada inspects medical device establishments: Assessing compliance with the Medical Devices Regulations

On this page

• Part 1: General
• Part 2: Custom-made devices and medical devices to be imported or sold for special access
• Part 3: Medical devices for investigational testing involving human subjects
• Part 4: Export certificates

This section explains what inspectors look for when they assess your compliance with the Medical Devices Regulations (the Regulations). It also directs you to more information that will help you understand and meet those requirements.

Sections 6 to 7: Classification of medical devices

If you are a manufacturer, you are responsible for classifying a medical device based on the rules in Schedule 1 of the Regulations. Failure to classify a device correctly may mean that you do not comply with the device’s licensing requirements.

Note: For information on Health Canada’s classification system and help in classifying your device, consult the following documents:

• Guidance for the risk-based classification system of in vitro diagnostic devices
• Guidance for industry: Keyword index to assist manufacturers in verifying the class of medical devices
• Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs)

If you need more help to classify your device, contact the Licensing Services Division of the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

Part 1: General

Sections 9 to 20: Manufacturer’s obligations and safety and effectiveness requirements

If you are a manufacturer, you are responsible for showing and maintaining evidence that you meet the safety and effectiveness requirements in sections 9 to 20 of the Regulations.

As a result, the inspector may look to see that you have:

• designed and manufactured a medical device that’s safe
• identified any risks the device may pose to health and safety
• made sure the device:
  • does not harm the health or safety of a patient
  • includes benefits that outweigh any possible hazards
  • suits its intended purpose
  • will not be harmed by transportation or storage conditions
• estimated the period of time the device will be useful to the average user, when applicable
• made sure the materials used to manufacture the device are compatible with other parts and with its surroundings during normal use
• designed, manufactured and packaged the device so that it will reduce foreseeable hazards, including:
  • flammability
  • explosion
  • presence of contaminant (chemical or microbial)
  • radiation
  • hazards (electrical, mechanical or thermal)
  • fluid leaking from or entering into a device
• manufactured sterile devices under appropriately controlled conditions and validated the sterilization method
• ensured any device intended to be used with other devices is compatible with the other devices
• ensured any device with a measuring function is within tolerance limits for its intended purpose
• designed software to perform as intended and validated the software’s performance

Note: For help in using international standards to meet safety and effectiveness requirements, consult the following guidance document:

• Recognition and use of standards under the Medical Devices Regulations

As a manufacturer, the inspector may ask you to show that your devices are safe and effective and perform as intended. You will need to provide records to support this request.

Note: Manufacturers, importers and distributors may also be cited under section 19 of the Food and Drugs Act (the Act) if there is evidence of a violation.
Section 19 of the Food and Drugs Act prohibits anyone from selling “any device that, when used according to directions … may cause injury to the health of the purchaser or user thereof.” If medical devices are not properly transported, stored or handled, their safety and effectiveness may be affected negatively. If you sell such medical devices, you may be in violation of the Act.

The inspector may also issue observations to manufacturers under sections 10 to 20 of the Regulations. The 2 most common observations are:

1. when you cannot back up claims made about a device (section 12, effectiveness for intended use)
2. concerns about how you transport or store a device (section 14, transport and storage)

Sections 21 to 23: Labelling requirements

When assessing compliance with sections 21 to 23, inspectors may ask questions to find out what type of controls you have in place to help you comply with labelling requirements. The inspector will also request labels for review.

Note: A label can be a legend, word or mark that is affixed to a medical device or its packaging. It can also be information such as manuals, package inserts, brochures and leaflets. If the device is sold to the general public in Canada, most information on the label must be in English and French.

The review will take into account your company’s product lines and device classes (Class I, II, III or IV). The number of labels the inspector looks at will depend on:

• your label controls and how effective they are
• your inspection history and how compliant you were with labelling and other requirements
• the number of devices you offer for sale

Note: For help with labelling your device, consult the following documents:

• Guidance for the labelling of in vitro diagnostic devices
• Guidance for the labelling of medical devices, not including in vitro diagnostic devices, appendices for labelling of soft, decorative, contact lenses and menstrual tampons

Section 24: Contraceptive devices – advertising

Inspectors will review advertisements of contraceptive devices for compliance. Under subsection 24(1), advertising for condoms sold to the general public can only claim to reduce the risk of transmitting sexually transmitted diseases. The advertisement cannot claim to prevent the diseases.

Section 25: Class I medical devices

If you manufacture Class I medical devices, you must comply with the safety and effectiveness requirements in sections 10 to 20 of the Regulations. For more information, refer to sections 9 to 20 above on the manufacturer’s obligations and safety and effectiveness requirements.

Health Canada’s Medical Devices Directorate (MDD) enforces the safety and effectiveness requirements. Following a complaint by a consumer (or a report from an inspector), the MDD may send you a letter directing you to take certain actions so that you meet those requirements. An inspector may then assess the actions you take to ensure they are carried out properly.

Sections 26 to 27: Class II, III and IV medical devices

If you import or sell a Class II, III or IV device, the device must have a valid medical device licence issued by Health Canada. Inspectors may ask questions to find out what type of controls you have in place to ensure that all Class II, III or IV devices imported, advertised or sold are properly licensed. This requirement does not apply to any devices subject to parts 2 (custom-made and special access) and 3 (investigational testing) of the Regulations.

Inspectors will assess your compliance with device licensing requirements in the following ways:

• confirm that medical device licences for products you import or sell (section 26) are valid by:
  • making sure the devices are licensed
  • taking into account your product lines, device classes and kinds of device licences
• look at medical device catalogues for warning labels that explain that not all the devices in the catalogue may be licensed for sale in Canada, if that is the case (section 27)
• look at samples of advertising material from recent marketing promotions
• confirm that the advertised devices are licensed, based on evidence you provide
• verify that the claims made on your website and your advertising material are valid by comparing them with the claims authorized by Health Canada in the medical device licence
• review distribution and warehouse records if a licence has been suspended, cancelled, refused or amended

For the most part, the number of samples the inspector looks at will depend on the controls you have in place to ensure you classify devices correctly. Sampling will also take into account:

• the complexity of your product lines
• how much and how complex is your advertising activity
• your company’s compliance history

As well, the inspector will consider the factors that result in amendments to the device licence (for example, a change in the device or manufacturer’s name or to the device identifier).

Sections 36 to 37: Issuance of medical device licence and lot of in vitro diagnostic devices

If a medical device licence has been issued with terms and conditions, or the terms and conditions have been amended, the inspector will look for evidence that you complied with these special conditions (section 36).

If a licence for an in vitro diagnostic device has been issued with terms and conditions, the inspector will look for evidence that you sent the required test results and protocols to Health Canada. The inspector will also confirm that when you sold the device, you did so in compliance with the Regulations.

Sections 44 to 51: Establishment licence

The inspector may ask you to provide the application form you completed to get your medical device establishment licence (MDEL). The inspector will then verify that the following information in your application form is accurate:

• manufacture, distribution and import activities
• name and address of manufacturers of devices you import or distribute
• documented procedures for, as applicable:
  • distribution records
  • handling complaints
  • recalls
  • incident reporting (if you are an importer)
  • provision of information concerning any serious risk of injury to human health (if you import Class II, III or IV devices)
  • handling, storage, delivery, installation, corrective action and servicing devices (if you import or distribute Class II, III or IV devices)

Note: Information on what to include in your procedures is in the checklist for procedures (Class II, III or IV devices). This checklist can be helpful since the inspector may note deviations, deficiencies or failures related to your procedures (such as not following shipping procedures when packaging a temperature sensitive medical device).

The inspector will review your procedures to ensure you are using them and they are adequate.

Note: A condition of getting an MDEL is having written procedures in place for various activities. When you completed the application or annual licence renewal for the MDEL, you were asked to confirm that you have the required written procedures in place.

Note: If you do not have the written procedures you attested to in the MDEL application or annual licence renewal, your MDEL may be suspended as per section 49 of the Regulations.

If your written procedures are inadequate, your company will not be considered compliant with certain sections of the Regulations.

For more information on how inspectors assess procedures, refer to the following sections:

• sections 52 to 55 for distribution records
• sections 57 to 58a for complaint handling
• section 58b and sections 63 to 65 for recalls
• sections 59 to 61.6 for incident reporting, serious risk of injury to human health and summary report

You can also find information on sections 44 to 51 of the Regulations in the:

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

Sections 52 to 55: Distribution records

Your distribution records should allow you to recall a medical device in an effective and timely way. The inspector will:

• look for evidence that you have distribution records
• assess how well those records enable you to retrieve a list of your customers for a particular product

For more information on the requirements for your distribution records, refer to:

• Medical devices recall guide (GUI-0054)

Sections 57 and 58a: Complaint handling

The inspector will review your procedures to see that you are using them and that they meet the requirements of the Act and Regulations. The inspector will also review your records of reported problems to see if:

• you are documenting reported problems and consumer complaints
• your records are complete and follow your procedures 
• you have taken actions to:
  • investigate the complaint
  • correct and prevent problems from happening again
  • follow up with the manufacturer, as needed

Note: For information on how to set up an effective system for investigating and resolving problems, consult the:

• Guidance on investigation of reported medical device problems (GUI-0065)

Section 58b and sections 63 to 65: Recall

The inspector will review your procedures to see that you are using them and that they meet the requirements of the Act and Regulations. The inspector will also review your recall records to see if:

• you are documenting recalls
• your records follow your procedures  
• you have taken actions to:
  • correct and prevent problems from happening again
  • notify your customers of the recall effectively and in a timely manner
  • submit recall reports to Health Canada
  • follow up with the manufacturer, as needed

For more information on how a device should be recalled, refer to:

• Medical devices recall guide (GUI-0054)

Sections 59 to 61.6: Incident reporting, serious risk of injury to human health and summary report

If you are a manufacturer or importer, the inspector will review your reports to see if:

• the process for identifying and reporting incidents is effective
• the incident reports meet reporting criteria in the Regulations
• information on serious risk of injury to human health is reported to Health Canada
• the summary reports are prepared and include the correct information, if you are a manufacturer of Class II, III or IV devices

Note: Consult the following documents for more information:

• Incident reporting for medical devices: Guidance document (what incidents should be reported and what to include in the report)
• Foreign risk notification for medical devices (foreign risk notification)
• Guidance on summary reports and issue-related analyses for medical devices (our expectations for preparing summary reports and issue-related analyses)

Sections 66 to 68: Implant registration

If you are a manufacturer, the inspector will review your implant registry to make sure it complies with sections 66 and 67. If you have been given permission to register implants with a different method, the inspector will review your records against the authorized method.

Part 2: Custom-made devices and medical devices to be imported or sold for special access

The inspector will identify and review custom-made or special access devices to make sure they comply with sections 69 and 70 and 75 to 78. The Medical Devices Directorate (MDD) normally assesses compliance with sections 71 to 74.

If you are a health care professional and you want permission to sell or import a custom-made or special access device, consult the Medical Devices Special Access Program for how to go about it.

Part 3: Medical devices for investigational testing involving human subjects

The inspector will identify and review devices used for investigational testing (clinical trials) to make sure they comply with sections 79 to 81 and 86 to 88.

The MDD normally assesses compliance with sections 82 to 85. These sections involve asking Health Canada to permit the sale or import of a device for investigational testing.

For information on how section 88, “Other requirements,” will be assessed, consult the following sections in this document:

• sections 52 to 55 for distribution records
• sections 57 to 58a for complaint handling
• section 58b and sections 63 to 65 for recalls
• sections 59 to 61.6 for incident reporting, serious risk of injury to human health and summary report

Note: For help in putting together the information needed to get permission to sell in vitro diagnostic devices and other medical devices for investigational testing, consult the following documents:

• Preparation of an application for investigational testing - In vitro diagnostics devices
• Applications for medical device investigational testing authorizations guidance document

Part 4: Export certificates

If you are exporting a device that is exempt from the Regulations because it falls under section 37 of the Food and Drugs Act, the inspector will confirm that:

• the device is manufactured or prepared in Canada
• the device is not manufactured for use in Canada
• the device is not sold for use in Canada
• the device label is clearly marked with the words “Export,” “Exportation” or “For Export”

The inspector will also verify that you are keeping:

• an export certificate for each shipment and that the certificate meets the requirements of subsection 89(2) of the Regulations
• export certificates for at least 5 years after the date of export (section 92 of the Regulations)