Compliance & Regulations | Health Canada
Health Canada’s expectation as a MDEL holder is that you are following the good practices (GMP) to ensure the quality of the Class I, Class II, Class III, Class IV medical devices you manufacture, import, distribute or retail. These practices are demonstrated by following documented procedures and completing forms associated with these procedures.
Health Canada will ask you to provide the application form you completed to get your establishment license. The inspector will then verify that the following information in your application form is accurate:
You may be asked for:​
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Medical Device Regulation's Compliant Documented procedures for:
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Distribution records
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Complaint Handling
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Recalls
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Mandatory problem reporting (replaced by incident reporting)
The additional Sops required for Class II & above are
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Handling, Storage & Delivery
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Corrective & Preventive Actions
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Installation
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Servicing
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Health Canada will review your documented procedures to ensure you are using them and they are adequate. If you do not have documented procedures, or they are inadequate, your company will not be considered compliant with certain sections of the Regulations.
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ISO 13485 (Class II and above)
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Manufacturers of medical devices classified as Class II, III, and IV must demonstrate compliance with ISO 13485 under MDSAP. MDSAP includes compliance with the QMS requirements of the Canadian Medical Devices Regulations (CMDR).
Health Canada requires you to provide an ISO 13485 quality system certificate as evidence of compliance to the Canadian Medical Device Regulations (CMDR). Certification of your MDSAP-compliant quality system by a Health Canada and MDSAP-accredited Auditing Organization (AO) is also required before your device can be sold in Canada.
We offer ISO 13485:2016 Documentation Toolkit, which is a set of ready-to-use templates designed as per general version of standard requirements. Our readymade ISO 13485 documents includes the following:
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ISO 13485 Quality Manual
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ISO 13485 Standard Operating Procedures
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Forms / Templates
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ISO 13485 Audit Checklist
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Work Instructions
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Our turn-key quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard.
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