Canada Class II Device Registration
Budget: $400 – $600 CAD
I have a new Class II surgical instrument ready for the Canadian market and all supporting data—clinical evidence, risk management reports, ISO 13485 certificate, bilingual labelling files—are complete and organised. Although my team has submitted several licences before, we are at capacity, so I am looking for a regulatory professional who can take this dossier over the finish line.
Your task is to:
• Review the existing documentation for Health Canada compliance and flag any gaps.
• Compile the Class II Medical Device Licence application in the correct format (fillable PDF + eCopy).
• Manage the submission through the appropriate Health Canada portal and track its progress.
• Draft or refine responses to any clarification requests until the licence is granted.
Experience with previous Class II submissions, knowledge of the Canadian Medical Devices Regulations (SOR/98-282), and familiarity with Health Canada’s turnaround expectations will be essential. If you can start quickly and keep communication clear and timely, let’s connect so the instrument can reach surgeons across Canada without delay.
Your task is to:
• Review the existing documentation for Health Canada compliance and flag any gaps.
• Compile the Class II Medical Device Licence application in the correct format (fillable PDF + eCopy).
• Manage the submission through the appropriate Health Canada portal and track its progress.
• Draft or refine responses to any clarification requests until the licence is granted.
Experience with previous Class II submissions, knowledge of the Canadian Medical Devices Regulations (SOR/98-282), and familiarity with Health Canada’s turnaround expectations will be essential. If you can start quickly and keep communication clear and timely, let’s connect so the instrument can reach surgeons across Canada without delay.
Related categories:
Project Management
Research
Medical
Research Writing
Medical Writing
Risk Management