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Medical Device Establishment Licence Application Form and Instructions - Form...
Display Title: Medical Device Establishment Licence Application Form and Instructions - Form 0292 File:...
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Mandatory Problem Reporting for Medical Devices Preliminary Report Form (Canada)
Display Title: Mandatory Problem Reporting for Medical Devices Preliminary Report Form File: ca-health-canada-mandatory-problem-reporting-for-medical-devices-preliminary-report-form.pdfResource...
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Form F202- Submission of a New or Modified Quality Management System...
Display Title: Form F202- Submission of a New or Modified Quality Management System Certificate File: canada-formf202-v2.pdfResource Category: Forms and Applications
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Form F201- Change of a Manufacturer's Registration Status (Canada)
Display Title: Form F201- Change of a Manufacturer's Registration Status File: canada-change-of-registration-status-form-f201-v2.pdfResource Category: Forms and Applications
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Application for a Medical Device Licence Amendment for a Private Label...
Display Title: Application for a Medical Device Licence Amendment for a Private Label Medical Device File: ca_app-licence-private-label-amendment.pdfResource Category: Forms and Applications
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Class IV Medical Device License Amendment Application Form (Canada)
Display Title: Class IV Medical Device License Amendment Application Form File: ca_app-class-iv-licence-amendment.pdfResource Category: Forms and Applications
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Class III Medical Device License Amendment Application Form (Canada)
Display Title: Class III Medical Device License Amendment Application Form File: ca_app-class-iii-licence-amendment.pdfResource Category: Forms and Applications
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Class II Medical Device License Amendment Application Form (Canada)
Display Title: Class II Medical Device License Amendment Application Form File: ca_app-class-ii-licence-amendment.pdfResource Category: Forms and Applications
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Application for a New Medical Device Licence for a Private Label Medical...
Display Title: Application for a New Medical Device Licence for a Private Label Medical Device File: ca_app-licence-private-label.pdfResource Category: Forms and Applications
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New Class IV Medical Device License Application Form (Canada)
Display Title: New Class IV Medical Device License Application Form File: ca_app-class-iv-licence-new.pdfResource Category: Forms and Applications
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New Class III Medical Device License Application Form (Canada)
Display Title: New Class III Medical Device License Application Form File: ca_app-class-iii-licence-new.pdfResource Category: Forms and Applications
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New Class II Medical Device License Application Form (Canada)
Display Title: New Class II Medical Device License Application Form File: ca_app-class-ii-licence-new.pdfResource Category: Forms and Applications
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Preparation of an Application for Investigational Testing - In Vitro...
Display Title: Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices File: canada-guidance-testing-for-in-vitro-devices-eng.pdfResource Category: Specific Guidance...
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Preparation of an Application for Investigational Testing - Medical Devices...
Display Title: Preparation of an Application for Investigational Testing - Medical Devices File: canada-guidance-application-for-investigational-testing-devices-eng.pdfResource Category: Specific...
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Health Canada - Guidance on Investigation of Reported Medical Device Problems...
Display Title: Health Canada - Guidance on Investigation of Reported Medical Device Problems - GUI-0065 File:...
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Health Canada - Guidance Document for Mandatory Problem Reporting for Medical...
Display Title: Health Canada - Guidance Document for Mandatory Problem Reporting for Medical Devices File:...
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Health Canada - Guide to Recall of Medical Devices - GUI-0054 (Canada)
Display Title: Health Canada - Guide to Recall of Medical Devices - GUI-0054 File: ca-health-canada-guide-to-recall-of-medical-devices-gui-0054.pdfResource Category: Specific Guidance Documents
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Canadian Establishment Licensing Important: Upcoming Changes (Canada)
Display Title: Canadian Establishment Licensing Important: Upcoming Changes File: ca-health-canada-establishment-licensing-upcoming-changes.pdfResource Category: General Guidance Documents
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Health Canada Licensing Fees - See ANNEX I (Canada)
Display Title: Health Canada Licensing Fees - See ANNEX I File: Canada-Official Notice of Fee Proposal for Human Drugs and Medical Devices.pdfResource Category: General Guidance Documents
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The Risk Based Classification System of In Vitro Diagnostic Devices - DRAFT...
Display Title: The Risk Based Classification System of In Vitro Diagnostic Devices - DRAFT File: CA_guidance-risk-based-classification-system-ivds.pdfResource Category: General Guidance Documents
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The Risk-based Classification System - DRAFT (Canada)
Display Title: The Risk-based Classification System - DRAFT File: CA_guidance-risk-based-classification-system.pdfResource Category: General Guidance Documents
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Labelling of In Vitro Diagnostic Devices - DRAFT (Canada)
Display Title: Labelling of In Vitro Diagnostic Devices - DRAFT File: CA_guidance-IVD-labelling-draft.pdfResource Category: General Guidance Documents
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Licensing Requirements for Inter-dependent Medical Devices - Notice (Canada)
Display Title: Licensing Requirements for Inter-dependent Medical Devices - Notice File: CA_guidance-licensing-reqs-inter-dependent.pdfResource Category: General Guidance Documents
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Health Canada Guidance on Transition to IEC 60601, 3rd Ed (Canada)
Display Title: Health Canada Guidance on Transition to IEC 60601, 3rd Ed File: health-canada-guidance-on-transition-to-eic-60601-3rd-ed.pdfResource Category: Specific Guidance Documents
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How to Complete the Application for a New Medical Device Licence/Medical...
Display Title: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device File:...
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Private Label Medical Devices Questions & Answers (Canada)
Display Title: Private Label Medical Devices Questions & Answers File: CA_guidance-private-label-QA.pdfResource Category: General Guidance Documents
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Private Label Medical Devices (Canada)
Display Title: Private Label Medical Devices File: ca_guidance-private-label.pdfResource Category: General Guidance Documents
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Medical Device Licence Renewal (Canada)
Display Title: Medical Device Licence Renewal File: ca_guidance-licence-renewal.pdfResource Category: General Guidance Documents
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Keyword Index to Assist Manufacturers in Verifying the Class of Medical...
Display Title: Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices File: CA_guidance-keyword-index-verify-class.pdfResource Category: General Guidance Documents
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Recognition and Use Of Standards under the Medical Devices Regulations (Canada)
Display Title: Recognition and Use Of Standards under the Medical Devices Regulations File: CA_guidance-standards-use.pdfResource Category: General Guidance Documents
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Information to be Provided by Manufacturers for the Reprocessing and...
Display Title: Information to be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices - DRAFT File: CA_guidance-reprocessing-sterilization-reusable.pdfResource...
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How to Complete the Application for a New Medical Device Licence (Canada)
Display Title: How to Complete the Application for a New Medical Device Licence File: CA_guidance-app-for-new-med-dev-licence.pdfResource Category: General Guidance Documents
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Health Canada - Guidance on the Content of Quality Management System Audit...
Display Title: Health Canada - Guidance on the Content of Quality Management System Audit Reports - GD211 File: health-canada-gd211-content-qms-audit-reports.pdfResource Category: General Guidance...
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Officially Recognized CMDCAS Registrars (Canada)
Display Title: Officially Recognized CMDCAS Registrars File: health-canada-list-of-recognized-registrars-2011.pdfResource Category: Major Regulations
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ISO 13485 Audit Guidelines (Canada)
Display Title: ISO 13485 Audit Guidelines File: Canada-CMDCAS-13485Audits-v2.pdfResource Category: Major Regulations
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Medical Devices Chapter 2 Canadian Requirements (Canada)
Display Title: Medical Devices Chapter 2 Canadian Requirements File: CA_reqs-chapter-2.pdfResource Category: Major Regulations
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Quality Systems ISO 13485 (Canada)
Display Title: Quality Systems ISO 13485 File: CA_quality-systems-iso-13485.pdfResource Category: Major Regulations
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Medical Devices Active Licence Listing (MDALL) (Canada)
Display Title: Medical Devices Active Licence Listing (MDALL) File: CA_medical-devices-active-licence-listing-mdall.pdfResource Category: Major Regulations
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Canadian Medical Devices Regulations - SOR 98-282 (Canada)
Display Title: Canadian Medical Devices Regulations - SOR 98-282 File: canada-medical-devices-regulations-sor-98-282-april-2-2012.pdfResource Category: Major Regulations
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Medical Device Licence Renewal - revised 1 April 2012 (Canada)
Display Title: Medical Device Licence Renewal - revised 1 April 2012 File: medical_device_licence_renewal.pdf
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