1. Health Products and Food Branch Direction générale des produits de santé et des aliments The Canadian Medical Devices Regulatory Program CESO Conference April 30, 2004 Don Boyer A/Director Medical Devices Bureau, Therapeutic Products Directorate, Health Canada don_boyer@hc-sc.gc.ca

2. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments MEDICAL DEVICES BUREAU MEDICAL DEVICES BUREAU

3. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Goals of the Regulatory System in Canada risked based approach post-market surveillance global harmonization international standards quality systems approach transparency and communication

4. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Regulatory Provisions: Essentials % Health Canada regulates the advertising, manufacture and sale of medical devices in Canada. % The Food and Drugs Act and Medical Devices Regulations are the tools used to ensure that safe and effective devices are available. % Manufacturers of devices apply to Health Canada to receive either a Licence or an Authorization to sell their devices.

5. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Regulatory Provisions: Essentials Foundation of the Medical Devices Regulations Degree of pre-market scrutiny based on the risk of a device Balance of pre-market, post-market and quality system Harmonize as much as much as possible with the regulatory approach of Canadas international trading partners

6. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments A manufacturer in the Regulations sells a medical device under: sells a medical device under: their own name, trade-mark, design, trade name or other name owned or controlled by the person their own name, trade-mark, design, trade name or other name owned or controlled by the person is responsible for : is responsible for : designing, manufacturing, assembling, processing, labelling, packaging,refurbishing or modifying the device, assigning it a purpose designing, manufacturing, assembling, processing, labelling, packaging,refurbishing or modifying the device, assigning it a purpose performs or has someone perform on their behalf performs or has someone perform on their behalf Manufacturer = Name on the label Regulatory Provisions: Essentials

7. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Device Licence Class II

8. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Device Licence Class III Device Licence Class III

9. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Device Licence Class IV

10. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Licences Held by Country of Manufacture December 2003

11. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Licences Renewed Annually

12. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Medical Devices Regulatory Program Key Components Medical Devices Bureau – premarket review of medical device licence applications, Investigation Testing, Special Access Program, Regulatory Interpretation, Support to Post-market investigations Medical Devices Bureau – premarket review of medical device licence applications, Investigation Testing, Special Access Program, Regulatory Interpretation, Support to Post-market investigations Health Products and Food Branch Inspectorate – Compliance and Enforcement – Establishment Licensing for Importers and Distributors Health Products and Food Branch Inspectorate – Compliance and Enforcement – Establishment Licensing for Importers and Distributors Marketed Health Products Directorate – Surveillance and Risk Communication Marketed Health Products Directorate – Surveillance and Risk Communication

13. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Medical Devices Regulations Section 26 ……..no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence ……..no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence Importers / Distributors / Manufacturers of Class I devices not employing a licensed importer / distributor require an Establishment Licence Importers / Distributors / Manufacturers of Class I devices not employing a licensed importer / distributor require an Establishment Licence

14. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Medical Devices Bureau Current Issues December 2003 letter to hospitals December 2003 letter to hospitals Evidence brought to Health Canadas attention indicates unlicensed medical devices Evidence brought to Health Canadas attention indicates unlicensed medical devices Letter makes two recommendations: Letter makes two recommendations: Purchase only licensed devices Purchase only licensed devices Conduct audit to ensure hospital is using licensed devices Conduct audit to ensure hospital is using licensed devices Auditor Generals Report on Medical Devices Regulatory Program Auditor Generals Report on Medical Devices Regulatory Program

15. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Medical Devices Bureau Current Issues Medical Device Active Licence Listing (MDALL) Medical Device Active Licence Listing (MDALL) www.mdall.ca: www.mdall.ca: www.mdall.ca All Class II, III and IV medical devices licensed by Health Canada All Class II, III and IV medical devices licensed by Health Canada Contains information such as manufacturers name, licence #, catalogue # Contains information such as manufacturers name, licence #, catalogue # QS requirements for manufacturers came into force January 1, 2003 / November 1, 2003 (renewal) – major impact for industry and TPD QS requirements for manufacturers came into force January 1, 2003 / November 1, 2003 (renewal) – major impact for industry and TPD

16. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Medical Devices Bureau Current Issues Reuse of Single-Use Devices (SUDs) Reuse of Single-Use Devices (SUDs) Reuse of Multiple-Use Devices Reuse of Multiple-Use Devices MDALL – only supplies information for currently valid licensed medical devices – no info on what was previously licensed, cancelled at renewal, suspended by HC, discontinued by manufacturer MDALL – only supplies information for currently valid licensed medical devices – no info on what was previously licensed, cancelled at renewal, suspended by HC, discontinued by manufacturer Delivery of healthcare is a shared responsibility – HC needs to develop effective / efficient partnerships with users / healthcare providers Delivery of healthcare is a shared responsibility – HC needs to develop effective / efficient partnerships with users / healthcare providers

17. Health Santé Canada Health Products and Food Branch Direction générale des produits de santé et des aliments Bureau Contacts Bureau Directors Office: Don Boyer (613) 957-4786 Associate Directors Office Nancy Richards (613) 946-6556 Quality Systems: Anne-Marie Coutu, (613) 954-0385 Medical Device Licensing / Classification / Regulatory Inquiries: Nancy Shadeed, (613) 954-0285 Device Evaluation Division / ITA / SAP: Dr. Irwin Hinberg, (613) 954-0298 Post-Market Surveillance: Dr. Philip Neufeld, (613) 954-0288