Medical Devices Regulations — Parts Overview

Quick reference by topic

Topic	Part	Key sections
Definitions	Part 1	s 1
Who must comply	Part 2	ss 3–6
Labelling requirements	Part 2	ss 21–26
Device Licence applications	Part 3	ss 26–43
MDEL applications	Part 4	ss 44–57
Distribution records	Part 5	ss 58–65
Mandatory problem reporting	Part 5	ss 59–64
Recalls	Part 5	s 65
Special Access Program	Part 6	ss 66–71
Investigational Testing Authorization	Part 6	ss 72–89
Custom-made devices	Part 7	s 90
Classification rules	Schedule 2	Rules 1–16 + IVD rules
Safety & effectiveness requirements	Schedule 1	All

Part 2 — General provisions

Part 2 contains requirements that apply to all regulated parties regardless of their role:

• General prohibition on selling non-compliant devices (s 3)
• Exemptions from Device Licence requirements (e.g. custom-made devices, investigational devices) (s 4)
• Labelling requirements — mandatory content for all devices (ss 21–26)

Part 3 — Device Licences

Part 3 is the core pre-market regulatory pathway for Class II–IV devices:

• Application requirements — what must be submitted (ss 32–33)
• Review and issuance — Health Canada's process (ss 36–38)
• Amendments — when and how to amend a licence (ss 34–38)
• Suspension and cancellation — grounds and process (ss 43–43.1)

Part 4 — Establishment Licences

Part 4 covers MDEL requirements:

• Who must hold an MDEL (s 44)
• Application requirements (ss 45–52)
• Maintenance obligations (ss 53–57)

Part 5 — Distribution Records and Problem Reporting

Part 5 covers ongoing post-market obligations:

• Distribution records — what must be kept and for how long (ss 58–59)
• Mandatory problem reporting — what must be reported and when (ss 60–64)
• Recalls — obligations when a recall is initiated (s 65)

Official source

Medical Devices Regulations (SOR/98-282)