How Health Canada inspects medical device establishments: Checklists

On this page

• Checklist of the provisions of the Regulations that apply to you
• Checklist for inspections
• Checklist for procedures (Class II, III or IV devices)

Checklist of the provisions of the Regulations that apply to you

Table 1 will help you find out which sections of the Medical Devices Regulations (the Regulations) apply to you. The requirements will vary depending on whether you are:

• manufacturer of Class I, II, III or IV devices
• importer
• distributor

A “yes” tells you the section of the Regulations you must comply with. Be sure to look at each activity you carry out to find out the requirements that apply to you.

Note: If you manufacture Class I medical devices, check paragraph 44(2)(d) of the Regulations to see if you need an establishment licence.

Checklist for inspections

Use the following checklist to help you prepare before, during and after a medical device establishment licence (MDEL) inspection.

Before the inspection

Gather:

• a copy of your most recent application or annual review for an MDEL
• written procedures for keeping distribution records and handling complaints and recalls
• written procedures for incident reporting, provision of information on serious risk of injury to human health (if you are an importer)
• written procedures for how to handle, store, deliver, install and service the Class II to IV devices you import and distribute
• a list of all medical devices you are currently selling
• a list of all manufacturers for the devices you are selling
• a list of all your suppliers for the devices you are selling

Check and confirm:

• documents (such as procedures, forms, records) are up to date and staff are using them
• the classification of all medical devices that you sell is correct
• any devices that should be licensed are licensed
• labelling information on all devices is correct
• labels of any devices sold to the general public are written in French and English
• any advertisements of the devices are correct

During the inspection:

• make sure staff is available to answer the inspector’s questions as needed

Be prepared to give the inspector:

• labels of selected medical devices
• advertising material for selected medical devices
• distribution records of selected medical devices
• records of complaints and the investigation and follow-up work you carried out
• recall reports, incident reports, foreign risk notification reports and summary reports (if this applies)
• documents related to how you handle, store, deliver, install and service Class II to IV devices (if this applies)
• records of authorizations for investigational (clinical) testing on human subjects (if this applies)
• records of authorizations for importing devices for special access (if this applies)

After the inspection

• schedule a closing meeting with the inspector
• follow up with the inspector on any questions you had during the inspection
• make sure you understand what you need to do to respond and correct the observations the inspector shared during the closing meeting
• take corrective and preventive actions or write a corrective action plan that outlines the actions and steps you have taken (or will take) to correct and prevent recurrence of deficiency noted in the inspector’s observations
• make sure your corrective action plan includes a timeline to carry out corrective and preventive actions for deficiencies that cannot be immediately corrected

Send the inspector the corrective and preventive actions or the corrective action plan (the Corrective action plan template outlines what to include when preparing your plan):

• within 20 business days of the issuance of the final inspection report (if you received a compliant rating)
• within 15 business days of the issuance of the draft inspection report (if you received a non-compliant rating)
• make sure your corrective action plan includes:
  • establishment name
  • MDEL number
  • number of observations identified in the inspection report
  • date of issuance of the inspection report
  • observation: enter the observation number and a description of the observation as outlined in the inspection report
  • root cause of the observation: the cause of a detected deficiency
  • risk: enter 1, 2 or 3 as identified in the inspection report
  • observation status: resolved or unresolved
  • corrective action(s) you have taken : actions taken to eliminate the root cause of a deficiency and to prevent recurrence
  • documents you are providing to support the corrective action(s): evidence of corrective actions you have already taken
  • name of the person or department responsible for the completion of the corrective action(s)
  • timelines/date for the completion of the corrective action(s), if applicable
  • preventive action(s) you have taken: actions to eliminate the cause of a potential deficiency
  • documents you are providing to support the preventive action(s): evidence of preventive actions you have already taken
  • name of the person or department responsible for the completion of the preventive action(s)
  • timelines/date for the completion of the preventive action(s), if applicable
• make sure you resolve and close all observations listed in the inspector’s report

Checklist for procedures (Class II, III or IV devices)

Use this checklist for help with your procedures for Class II, III and IV devices. The checklist covers how to handle, store, deliver, install, correct and service the devices.

Procedures for storing, handling and delivering Class II, III or IV devices

Keeping in mind the types of medical devices you deal with, check to see if your procedures address the following:

• how to protect devices from environmental conditions that may affect their safety or effectiveness
• how to identify devices that need special storage or transport conditions (for example, test kits containing reagents that must not be frozen)
• how to store, handle and deliver medical devices that have special storage or transport conditions
• how to rotate your stock of devices that has a limited shelf-life or expiry date (for example, first in, first out)
• how to handle or store devices to prevent damage, deterioration, mix-ups, contamination or other adverse effects
• how to keep returned or recalled devices separate from other devices to prevent them from being shipped by mistake
• how to verify orders before they are shipped to avoid the wrong device from going out

Procedures for installing Class II, III or IV devices

If your device must be put together for use, check to see if your procedures address the following:

• how to train and certify employees to install, inspect and test devices that need it
• how to make sure only properly trained and qualified employees install, inspect and test devices that need it
• how to make sure that employees follow the manufacturer’s instructions for installing, inspecting and testing devices that need it
• how to make sure employees justify deviations from the manufacturer’s instructions when installing, inspecting and testing devices that need it
• how to make sure testing equipment will perform as needed when taking measurements
• how often testing equipment is calibrated

Procedures for servicing Class II, III or IV devices

Keeping in mind the types of devices you deal with, check to see if your maintenance and repair procedures address the following:

• how to train and certify employees to service devices
• how to make sure only properly trained and qualified employees service devices
• how to make sure maintenance work (for example, cleaning, lubrication, adjustment, inspection, part replacement, calibration and testing) is performed as instructed by the manufacturer
• whether there is a schedule for doing maintenance work
• whether the schedule for doing maintenance work meets or exceeds the timelines set by the manufacturer
• whether you keep a record of servicing work done
• whether your servicing records specify:
  • name and location of the device
  • installation date
  • device identifier (model number)
  • serial number or lot number (whichever applies)
  • date of service work
  • name of the staff person doing the servicing work
  • service performed, including replacement part and any testing or inspection data
• how often servicing equipment is tested, calibrated and serviced
• how to monitor repairs for trends that show premature or unexpected device failure or malfunction (especially where failure or malfunction may pose a risk to health)
• how to investigate reports of unexpected failure or deterioration in device performance
• when investigations should include inspections of the suspect device in other facilities to figure out the extent of the problem
• when and how to inform the manufacturer of unexpected failure or deterioration in device performance
• whether to forbid staff from modifying the function, design or performance specifications of the device during repairs, unless given express permission by the manufacturer
• how to get permission from the manufacturer to modify the function, design or performance specifications of the device during repairs
• whether to forbid staff from using parts or components that have not been permitted by the manufacturer (especially if they do not meet the specification of the original manufacturer’s parts)
• how to identify the parts or components that can be used for repairs of specific devices
• where to find the specifications of the original manufacturer’s parts