ISO 13485 certification in Canada

ISO 13485 certification in Canada at a glance

Health Canada writes ISO 13485 directly into its licensing rules. Under the Medical Devices Regulations, an application for a Class II, III or IV medical device licence must include a copy of a quality management system certificate showing that the system under which the device is made, or designed and made, meets National Standard of Canada CAN/CSA-ISO 13485, and the certificate must come from a registrar recognised by the Minister. That makes the choice of certification body a regulatory decision, not just a commercial one, and manufacturers should confirm the current recognition route on Health Canada's site before booking an audit. Contract manufacturers and component suppliers feel the effect too, because device makers extend their quality requirements to critical suppliers. Sterling's Toronto office builds ISO 13485 systems covering design controls, risk management, supplier controls, complaint handling and post-market processes, and prepares manufacturers for the recognised registrar's audit; Effivity and Sterling Academy are included. Licensing questions follow.

Who needs ISO 13485 in Canada, and what happens without it

For some organisations in Canada it is a legal requirement. For most, the question comes from a buyer, a regulator or a partner that wants proof before it signs. These are the organisations that get asked.

• Manufacturers applying for Class II, III or IV medical device licencesApplications must include a quality management system certificate to CAN/CSA-ISO 13485.
• Foreign manufacturers selling devices into CanadaThe same licensing requirement applies to the manufacturer of the device.
• Contract manufacturers and component suppliersDevice makers flow quality management requirements to critical suppliers.

ISO 13485 requirements in Canada

Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.

In Canada these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →

• ISO 13485 requirements, clause by clause in plain language

How to get ISO 13485 certified in Canada

One team from the Toronto office carries the work from scoping to certificate. Delivered from the Toronto office: on-site in Ontario and by arrangement in other provinces; remote delivery for distributed teams.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO 13485 and the Canadian requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
5. Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• The ISO 13485 certification process, step by step
• ISO 13485 internal audit

How long does ISO 13485 certification take in Canada?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Canada these are the factors that set the timeline.

• Device classes and number of sites in scope
• Maturity of design controls, risk management and complaint handling
• Time to evidence production and post-market records

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• Scope and timeline estimator

How much does ISO 13485 certification cost in Canada?

The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In Canada these factors move both.

• Number of sites, device families and outsourced processes
• Regulatory submissions running in parallel
• Certification body audit fees quoted separately from consulting

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 13485

ISO 13485 consultants and certification bodies in Canada

Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Canada are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 13485 in Canada: questions clients ask

More on ISO 13485 for Canadian organisations

• ISO 13485: the complete guide
• Watch: How to implement ISO 13485
• Sterling in Toronto
• ISO 13485 certification in Canada and every other standard Sterling delivers there

Other standards Canadian businesses ask Sterling for

Organisations in Canada often combine ISO 13485 with one of these, under one management system where the scopes allow.

All 21 standards Sterling delivers in Canada →