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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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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 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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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 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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ISO 13485 Audit Guidelines (Canada)

Display Title:  ISO 13485 Audit Guidelines File: Canada-CMDCAS-13485Audits-v2.pdfResource Category:  Major Regulations

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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