Getting Medical Device Approval in Canada

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With 35,000,000 people and a well organized healthcare system, Canada is an excellent market for medical devices. We'll explain the Canadian approval process step by step.

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Getting Medical Device Approval in Canada

  1. 1. The medical device registration process in Canada Medical Device Registration in Canada How to obtain regulatory approval to market your medical device in the Canadian marketASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  2. 2. The medical device registration process in Canada Key Topics •Device Classification according to Canadian Medical Devices Regulations (CMDR) •Medical Device Establishment Licenses (MDEL) •Medical Device Licenses (MDL) •ISO 13485 Quality System Implementation •Quality System Auditing •Premarket Review Document Preparation •Timeframes and CostsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  3. 3. The medical device registration process in Canada Canada: Large Country, Small PopulationWorld’s second largest country.9,984,670 km² (3,855,103 mi²).34.5 million people Sources: Canada Facts, www.canadafacts.org Natural Resources Canada , www.nrcan.gc.caASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  4. 4. The medical device registration process in Canada Overview of Canada’s Medical Device Market • $6 billion in annual revenues • $2.4 billion in annual exports, primarily to the US • 1,500 Canadian medical device firms with 35,000 employees • Industry concentrated in Ontario and Quebec (80% of Canadian medical device firms located in these provinces) Sources: MEDEC, Invest in CanadaASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  5. 5. The medical device registration process in Canada Determining Device Classification First, determine your device’s classification using the Canadian Medical Devices Regulations (CMDR). Class I Class II Class III Class IV Low Risk High Risk http://www.emergogroup.com/files/canada-medical-devices-regulations-v2.pdfASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  6. 6. The medical device registration process in Canada Determining Device Classification • For Non-IVDD – 16 Rules addressing invasive/non- invasive/ active / special devices •Keyword Index • Medical Device Active Licence Listing (www.mdall.ca)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  7. 7. The medical device registration process in Canada Determining Device Classification • For IVDD – 9 Rules addressing intended use / indications for use •Keyword Index (draft) • Medical Device Active Licence Listing (www.mdall.ca)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  8. 8. The medical device registration process in Canada Examples of Classifications • Medical Devices: – Class I: band-aids, compression, non-invasive – Class II: condoms, invasive, blood pressure monitors – Class III: laser devices, blood touching, implants – Class IV: human tissues, active implantables • In Vitro Diagnostics: – Class I: microbiology tests, everything else – Class II: patient management, moderate level diagnostics – Class III: sexually transmitted diseases, moderate to high level – Class IV: death or serious injury diseases, detecting high level diagnosticsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  9. 9. The medical device registration process in Canada Class I Manufacturers If you are a manufacturer and plan to sell a Class I device in Canada without using an established Canadian distributor, you must apply for a Medical Device Establishment License (MDEL).ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  10. 10. The medical device registration process in Canada Classes II-IV Manufacturers If you are a manufacturer and plan to sell Class II, III and IV devices in Canada, regardless of whether you are using a distributor or not, you must apply for Medical Device Licenses (MDL) as part of the Canadian registration process.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  11. 11. The medical device registration process in Canada Importers & Distributors: All Device Classes All distributors and importers, whether based in Canada or not, must apply for a Medical Device Establishment License (MDEL).ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  12. 12. The medical device registration process in Canada Medical Device Establishment Licence (MDEL) The purpose of the MDEL is 1. To ensure that Health Canada is aware of: a) importers and/or distributers of medical devices in or into Canada, b) the identity of the manufacturers of the devices sold by the holder of the MDEL c) the identity of Class I device manufacturers who distribute their own devices. 2. To require licence holders to provide some assurance to Health Canada that they have met the regulatory requirements, including having the required documented procedures in placeASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  13. 13. The medical device registration process in Canada MDEL: Key Elements • Completed Medical Device Establishment License, including a list of the manufacturers of all devices imported and/or distributed • Quality System Procedures (SOPs) addressing the requirements of the Canadian Medical Devices Regulations • MDEL Fee FormASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  14. 14. The medical device registration process in Canada Medical Device Licence (MDL) • Only a “Manufacturer” can apply for a Medical Device Licence – means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  15. 15. The medical device registration process in Canada Classes II-IV Medical Device Licenses: Quality System Requirements Manufacturers of Class II, III and IV devices are required to implement quality systems compliant with ISO 13485:2003 in Canada. (Health Canada does not require ISO 13485 for Class I devices.)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  16. 16. The medical device registration process in Canada ISO 13485 Compliance ISO 13485 certification requires you to develop written policies for the following functions: •Document and record controls •Internal auditing procedures •Controls for non-conformance •Corrective and preventative actions •Process and design controls Except Class 2 •Record retention practices Devices •Accountability and traceability Health Canada requires that the written procedures address the requirements as listed in the Canadian Medical Devices RegulationsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  17. 17. The medical device registration process in Canada Quality System Auditing • Your ISO 13485 quality system must be audited by a Registrar accredited under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) by Health Canada.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  18. 18. The medical device registration process in Canada Quality System Auditing • Following a successful audit, you will receive your ISO 13485: 2003 certification. NOTE: Health Canada has issued a new guidance document addressing the content of the ISO Registrar’s Quality Management System Audit Report (GD211)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  19. 19. The medical device registration process in Canada MDEL and MDL Applications Distributor Class I Class II Importer Manufacturer Manufacturer Submit MDL Submit MDEL Submit MDEL application, ISO application to HC application to HC 13485 certificate, with list of with details on IFU and manufacturers your Class I device Declaration of Conformity to HCASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  20. 20. The medical device registration process in Canada MDEL and MDL Applications Class III Class IV Manufacturer Manufacturer Submit MDL application, ISO 13485 certificate, IFU, Declaration of Conformity and Premarket Review Document to HCASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  21. 21. The medical device registration process in Canada Class III and IV: Premarket Review Document Class III and IV device manufacturers must prepare a Premarket Review Document along with an MDL application.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  22. 22. The medical device registration process in Canada Elements of Premarket Review Document •Summary of safety and effectiveness studies •Risk assessment •Quality plan* •Device-specific detailed information •Labeling information •Quality system requirements •Sales & Marketing Summary Health Canada requires clinical trial data to be included in your Premarket Review Document for Class IV devices. Data from clinical trial conducted in other medical device markets may be accepted.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  23. 23. The medical device registration process in Canada Format of Premarket Review Document • Effective November 1, 2011 all applications for Class III and IV Medical Device Licenses (non-IVDD) are strongly recommended to follow the Summary Technical Documentation (STED) format with the Health Canada specific requirements • All applications for Class III and IV Medical Device Licenses need to be submitted in both paper and electronic formats, where the electronic format is a duplication of the paper submission following Health Canada’s Guidance http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md- im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.pdfASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  24. 24. The medical device registration process in Canada Format of STED Document Table of Contents Section/Sub-section Main Heading Application Location Module 1 Health Canada Requirements tab or pages volume section 1.0 Table of Contents 2.0 Administrative Information 2.1 Application Form and Fee Form 2.2 Quality Management System Certificate 3.0 Pre-Submission Correspondence 4.0 Additional Class III Premarket Information 4.1 Cover Letter 4.2 Executive Summary 4.3 Submission Traceability Table for Class III Applications 4.4 Licence Amendments 4.5 Design Philosophy 4.6 Indications and/or Intended Use and Contraindications 4.7 Marketing History/Regulatory Status 4.7.1 Canadian 4.7.2 International 4.7.3 Incident Reports and Recalls 4.8 Standards (Health Canada Declaration of Conformity) 4.9 Shelf Life Validation for Product 4.10 Summaries 4.11 BibliographyASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  25. 25. The medical device registration process in Canada Format of STED Document Table of Contents Section/Sub-section Main Heading Application Location tab or pages volume section Module 2 Summary Technical Document (STED)-based Requirements 5.0 Device Description and Product Specification, Including Variants and Accessories 5.1 Device Description 5.2 Product Specification 5.3 Reference to Similar and Previous Generations of the Device 6.0 Labelling 7.0 Design and Manufacturing Information 7.1 Device Design 7.2 Manufacturing Process 7.3 Design and Manufacturing Sites 8.0 Essential Principles (EP) Checklist 9.0 Product Verification and Validation 9.1 General 9.2 Biocompatibility 9.3 Medicinal Substances 9.4 Biological Safety 9.5 Sterilization 9.6 Software Verification and Validation 9.7 Animal Studies 9.8 Clinical EvidenceASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  26. 26. The medical device registration process in Canada Format of STED Document Submission Traceability – Class 3 Health Canada Section/ Review Areas Application Location Corresponding Summary Technical Document (STED) Section/ Subsection (For internal tab or pages Subsection use Only) section 1 Background Information 1.1 Device Description 1.1.1 General Device Description 6.1, 6.2, 11.3 1.1.2 Licence Amendments Not Applicable (N/A) 1.2 Design Philosophy 6.1 c) 6.3 1.3 Indications and/or Intended Use N/A 2 Device Labels, Package Labelling and 7 Documentation 3.0 Marketing History/Regulatory Status N/A 3.1 Canadian 3.2 International 3.3 Incident Reports and Recalls 4 Safety and Effectiveness Studies 4.1 Standards 11.1 a) b) 3rdpara. 4.2 Preclinical Studies 4.2.1 Physical/Mechanical/Bench Tests 11.1 a)b)c) 2ndPara 4.2.2 Shelf Life Studies of Product N/A 4.2.3 Software Verification and Validation 11.6 4.2.4 Biocompatibility Tests 6.1f), 11.2 4.2.5 Animal Studies 11.1, 11.7 4.3 Clinical Evidence 11.8,GHTF/SG5/N2 4.4 Sterilization 11.5 4.5 Literature Studies and Bibliography 11.1 e) 2ndpara.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  27. 27. The medical device registration process in Canada Format of Class III MDL - IVDDASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  28. 28. The medical device registration process in Canada Format of Class IV MDL – IVDD Device Licence Application Form Executive Summary Table of Contents 1 Background Information 1.1 Device Description 1.2 Design Philosophy 1.3 Marketing History 2 Risk Assessment 3 Quality Plan 4 Device Specific Detailed Information 4.1 Material Specifications 4.2 Manufacturing Process Specifications 4.2.1 Method of Manufacture 4.2.2 Quality Control Activities 4.3 List of Standards 5 Safety and Effectiveness Studies 5.1 Preclinical and Clinical Studies 5.1.1 Sensitivity/Specificity 5.1.2 Validation of Cutoff 5.1.3 Interference 5.1.4 Reproducibility 5.1.5 Stability 5.2 Process Validation Studies 5.3 Software Validation Studies (if applicable) 5.4 Literature Studies 5.5 Other Studies 6 Additional information for Near-Patient IVDDs (if applicable) 7 Device Label 8 Quality System AuditASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  29. 29. The medical device registration process in Canada Device-Specific Guidance Documents • Device Licence Applications for Ultrasound Diagnostic Systems and Transducers (http://www.hc-sc.gc.ca/dhp-mps/md- im/applic-demande/guideld/ultrasound_ultrasons-eng.php). • Guidance Document on the Regulation of Medical Devices Manufactured From or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s) (http://www.hc- sc.gc.ca/dhp-mps/md-im/applic-demande/guide- ld/anim_tisseng.php). • Pre-Market Guidance on Bare Cardiovascular Stents (http://www.hc-c.gc.ca/dhpmps/md-im/applic- demande/guide-ld/stents_nues-eng.php).ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  30. 30. The medical device registration process in Canada Device Specific Guidance Documents, cont’d. • Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications (http://www.hc-sc.gc.ca/dhp-mps/mdim/applic- demande/guide-ld/breast_impl_mammaires-eng.php). • Consultation on the Release of Draft Guidance Document- Medical Device Applications for Implantable Cardiac Leads (http://www.hc-sc.gc.ca/dhpmps/consultation/md- im/consult-draft_ebauche_cardi_lead_sondes-eng.php)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  31. 31. The medical device registration process in Canada Licence Review MDEL Class II Timeline: Timeline: 15 days Goal < 120 days Actual (Q1 2012) – 24 days Reality ≈ 60 days Application Fee: $357CDN Annual License Fee: $7344CDN License Renewal Fee: $337CDN (can be reduced to 1% of actual gross revenue) Fees are due at time of submission Fee remission (based 1% of gross revenues in Canada) can be requested for MDEL applicationsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  32. 32. The medical device registration process in Canada MDL Review Class III Class IV Timeline: 75 days Timeline: 90 days Actual (Q1 2012) – 160 days Actual (Q1 2012) – 163 days Application Fee: $5151CDN Application Fee: $11,985CDN Near patient IVD- $8772CDN (human/animal tissue)$11,180CDN License Renewal Fee: $337CDN (near patient IVD) $20,431CDN License Renewal Fee: $337CDN Fees will be invoiced to company after submission Companies can request fee remission or a one –year fee deferral (for new companies only)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  33. 33. The medical device registration process in Canada MDEL and MDL Approval For Class I MDEL devices, Health Canada issues a MDEL Certificate, which is re-issued annually* For MDL applications, Health Canada issues a MDL certificate and post the approval status on its website (www.mdall.ca).ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  34. 34. The medical device registration process in Canada Sample MDEL Sample MDLASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  35. 35. The medical device registration process in Canada Private Label Medical Device Licence (PLMDL) • "private label medical device" - a medical device that is identical in every respect to a licensed medical device manufactured by an original manufacturer, except that the device is labelled with the private label manufacturer’s name, address and product name and identifier. • The Private Label “manufacturer” does not require certification to ISO 13485; however, they do require Quality System Procedures similar to those for holders of MDELsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  36. 36. The medical device registration process in Canada Private Label Medical Device Licence (PLMDL) • Essentially an agreement between the Private Label “manufacturer”, the original equipment manufacturer and Health Canada • There are no fees for the review of the application • Review timelines are comparable for Class II devices and much shorter than those for Class III and Class IV devicesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  37. 37. The medical device registration process in Canada Completion of Registration You are now approved to sell your medical device in Canada. Health Canada requires annual license renewals and fees to maintain your registration.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  38. 38. The medical device registration process in Canada Licence Updates/ Renewals - MDL • Updating ISO Certificates – Form F-202 to be submitted within 30 days of issuance • Company relocation – Fax-Back Form + F-202 • Company name change - Fax-Back Form + F-202 • Device name changes or changes to parts – Fax-Back Form • Discontinue sale of medical device – within 30 days • Annual licence renewals are due before November 1 using form supplied by Health Canada (fees will be invoiced)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  39. 39. The medical device registration process in Canada Licence Updates/ Renewals - MDEL • Company relocation / company name change / change to company contact – noptify Health Canada within 15 days using MDEL Form • Annual licence renewals are due before April 1 using MDEL form – Fees are due at time of renewal – however, a fee remission can be requested* * Due to large volume of MDEL renewals, companies are recommended to submit MDEL renewals as early as possible to avoid delays in renewal of the licenceASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  40. 40. The medical device registration process in Canada For additional information: Medical device regulations in Canada: http://www.emergogroup.com/resources/regulations-canada Medical device regulatory process chart for Canada: http://www.emergogroup.com/files/medical-device-regulatory-process-canada.pdf Consulting services for Canada: http://www.emergogroup.com/services/canada Questions? Daryl Wisdahl EMERGO GROUP | Managing Director, Canada dw@emergogroup.com Canada office: +1 888 254 3160ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com

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