MDSAP · Medium · 14 min lesson
Canada - Medical Devices Regulations SOR/98-282, licences, mandatory problem reporting and recalls
SOR/98-282 sections 32, 34, 46.1, 59 to 61.1 and 63 to 65.1, Health Canada MDSAP notice, MDSAP Audit Approach chapters 1, 2 and 4
What you will learn
- Explain the licence and MDSAP certificate link.
- Apply problem reporting and recall rules.
- Read the Health Canada notices.
Key takeaways
- A class II to IV licence rests on an MDSAP certificate whose scope covers the device and the sites.
- Problem reports run from company awareness: 10 days for serious outcomes, 30 for potential ones.
- Recall decisions are notified within 24 hours, with initial and final reports to follow.
- Read notices by status, date and owner, and log the action.
- Keep Canadian rules inside clauses 8.2.2, 8.2.3 and 8.3.3 of your QMS.
Free practice question
Aldercrest adds a third moulding site. Quality says the MDSAP audit is due in eight months, so the licence can stay as it is until then.
What is the right action?
Open a Canada action before the site produces for Canada, check certificate scope and any licence amendment, and block shipments until aligned.
Correct. Section 32 ties the licence to the MDSAP certificate, and the Audit Approach checks that listed sites match those in use.
Wait for the next audit and ship in the meantime.
Not quite. Shipping from a site outside certificate scope leaves the licence unsupported under section 32 and MDSAP expectations.
Tell Health Canada after the first shipment.
Not quite. Notifying after shipping is too late because a significant change may need an amendment first under section 34.
Ignore it because moulding is a subcontracted step.
Not quite. Outsourced processes stay within the quality system under ISO 13485 clause 4.1.5 and MDSAP chapter 7.
Key terms
- licence (MDL): Authorization to sell a class II, III or IV device in Canada, issued to the manufacturer named on the label (SOR/98-282).
- establishment licence (MDEL): A licence for companies that import or distribute devices in Canada; it is separate from the device licence.
- MDSAP certificate: Quality management system certificate from an MDSAP auditing organization that supports a Canadian licence application.
- mandatory problem reporting: Reporting of incidents that led or could lead to death or serious deterioration, under sections 59 to 61.1.
- day zero: The day the company, not one person, becomes aware of the incident; the reporting period runs from it.
- recall types: Recalls are classed by health risk; classes one to three, with type three still reportable in some cases (Health Canada recall guide).
- significant change: A change to a class III or IV device that needs an approved licence amendment before sale (section 34).
- archived guidance: A document kept for reference that may be superseded; check current status before using its content.
Official sources
- Medical Devices Regulations SOR/98-282 (Justice Laws Website)
- Guidance Document for Mandatory Problem Reporting for Medical Devices (archived, Health Canada)
- Guide for recalling medical devices (GUI-0054): Recall reporting and process (Health Canada)
- Notice: ISO 13485 quality management system certificates and recognized registrars (Health Canada)
- MDSAP AU P0002.009, MDSAP Audit Approach (FDA)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.