How Health Canada inspects medical device establishments: Checklists

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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:

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.

Table 1: Sections of the Medical Devices Regulations that apply, by activity
Requirements Section number Manufacturer of Class I devices Manufacturer  of Class II, III or IV devices Importer Distributor
Part 1, General
Safety and effectiveness 9 to 20  yes yes n/a n/a
Labelling 21 to 23 yes yes yes yes
Contraceptive advertising 24 n/a yes yes yes
Class I devices 25 yes n/a n/a n/a
Class II, III and IV devices
Sale 26 n/a yes yes yes
Advertising 27 n/a yes yes yes
Licensing 28 to 32 n/a yes n/a n/a
Foreign manufacturers 33 Not in effect at this time.
Licence amendment 34 n/a yes n/a n/a
Additional information and samples 35 n/a yes n/a n/a
Issuance 36 n/a yes n/a n/a
Lot of in vitro diagnostic devices 37 n/a yes n/a n/a
Refusal to issue 38 n/a yes n/a n/a
Additional information 39 n/a yes n/a n/a
Suspension 40 to 42 n/a yes n/a n/a
Obligation to inform 43 n/a yes n/a n/a
Establishment licence
Establishment licensing 44 yes n/a yes yes
Application 45 yes n/a yes yes
Issuance 46 yes n/a yes yes
Refusal 47 yes n/a yes yes
Notification 48 yes n/a yes yes
Suspension 49 yes n/a yes yes
Records
Distribution records 52 to 55 yes yes yes yes
Complaint handling 57 to 58 yes yes yes yes
Incident reporting, serious risk of injury to human health and summary report 59 to 61 yes yes yes n/a
Recall 63 to 65 yes yes yes n/a
Implant registration 66 to 68 n/a yes n/a n/a
Part 2: Custom-made devices and medical devices to be imported or sold for special access
General 70 yes yes yes yes
Authorization 71 to 72 yes yes yes n/a
Additional information 73 yes yes yes n/a
Labelling 75 yes yes yes yes
Distribution records 76 yes yes yes n/a
Incident reporting 77 Reporting requirements apply to health care professionals Reporting requirements apply to health care professionals Reporting requirements apply to health care professionals Reporting requirements apply to health care professionals
Implant registration 66 to 68 n/a yes n/a n/a
Part 3: Medical devices for investigational testing involving human subjects
General - sale or importation 80(1) yes yes yes yes
General - Class II, III and IV devices authorization 80(2) yes yes yes n/a
General - Class I device 80(3) yes n/a yes n/a
Records 81 yes yes yes yes
Authorization 82 to 83 yes n/a yes yes
Additional information 84 to 85 yes yes yes n/a
Labelling 86 yes yes yes yes
Advertising 87 yes yes yes yes
Distribution record, complaint handling, incident reporting, recall and implant registration requirements 88 yes yes yes yes
Part 4: Export certificates
Export certificates 89 to 92 yes yes yes yes

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:

Check and confirm:

During the inspection:

Be prepared to give the inspector:

After the inspection

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):

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:

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:

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:

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