1. Overview of Medical Devices Regulations Velocity Science Sarah Chandler A/Manager, Device Licensing Services Division Medical Devices Bureau Health Canada sarah.chandler@canada.ca

2. Medical Device Stakeholders 2

3. Brief History of the Canadian Medical Device Regulatory Framework 3 Medical Devices Regulations (MDR) come into force on September 2. 1975 1977 MDR amended to include premarket review for some devices. 1991 Medical Devices Review Committee (MDRC) created to assess regulation. 1992 MDRC publish their report which includes several recommendations. 1997 The Medical Devices Bureau is unified under one Directorate. 1998 The new MDR comes into effect, making licensing a requirement. 2015 Greater than 35000 Medical Device Licences renewed.

4. Regulatory Framework Canada has incorporated successful elements from other regulatory systems into our own regulations:  Risk Based Classification System  Quality System Requirement  Pre-Market Licensing  Post-Market Regulation 4

5. Regulatory Tools 5

6. Health Canada’s Medical Devices Program HEALTH PRODUCTS & FOOD BRANCH (HPFB) 6 ATLANTIC BC ONTARIO PRAIRIE QUEBEC HPFBI SERVICE DELIVERY FUNCTION (FIELD INSPECTION) REGIONS & PROGRAMS BUREAU RAPB RISK MANAGEMENT BUREAU LICENSING & INSPECTION BUREAU POST-MARKET SAFETY SURVEILLANCE, ASSESSMENT OF SIGNALS & SAFETY TRENDS, AND RISK COMMUNICATIO NS POST-MARKET COMPLIANCE MONITORING AND ENFORCEMENT ACTIVITIES SUPPORTED BY AN ESTABLISHMENT LICENSING SYSTEM THERAPEUTIC PRODUCTS DIRECTORATE TPD MARKETED HEALTH PRODUCTS DIRECTORATE MHPD HEALTH PRODUCTS & FOOD BRANCH INSPECTORATE HPFBI PRE-MARKET ASSESSMENT OF MEDICAL DEVICE SAFETY, EFFECTIVENESS & REGULATORY COMPLIANCE, SUPPORTED BY A LICENSING SYSTEM INTENDED TO REGULATE MARKET ACCESS ESTABLISHMENT LICENSING UNIT MEDICAL DEVICES BUREAU BORDER INTEGRITY UNIT MARKETED PHARMA & MD BUREAU MEDICAL DEVICES COMPLIANCE UNIT

7. What is a Device? Section 2 of the Food & Drugs Act: 7

8. What is a Medical Device? Section 1 of the Medical Devices Regulations: 8

9. Regulatory Provisions All devices offered for sale in Canada must comply with the Food and Drugs Act: –Cannot advertise or represent by label a treatment for a Schedule A disease or disorder (Section 3) –Cannot sell or advertise a device that may cause harm –Cannot sell or advertise a device in a misleading or deceptive way All medical devices (those used on human beings) must also comply with the Medical Devices Regulations 9

10. Regulatory Provisions The Regulations apply to: –The sale and advertising for sale of a medical device –The importation of a medical device for sale or for use on individuals, other than importation for personal use Manufacturers of medical devices apply to Health Canada to receive either a Licence or an Authorization to sell their devices. 10

11. Regulatory Provisions A manufacturer: –Sells a medical device under their own name, trade- mark, design, trade name or other name owned or controlled by the person –Is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, assigning it a purpose –Performs or has someone perform on their behalf Manufacturer = Name on the label 11

12. Classification of Medical Devices MDR sets out a system for classifying medical devices into one of four classes. Low RiskHigh RiskModerate Risk Class IClass IIClass IIIClass IV Increasing Regulatory Oversight 12

13. 11 22 33 44 Class I - Premarket regulatory oversight based on establishment licensing - Post-market oversight based on compliance to applicable sections of the MDR Class II - Certification that device is manufactured according to international Quality Management System standard (ISO 13485). - Manufacturer’s attestation that device satisfies the safety, effectiveness requirements in MDR. Label reviewed. Class III - Certification that device is designed & manufactured according to ISO 13485 - Evidence of safety, effectiveness & labelling reviewed to validate compliance with MDR. Class IV - Certification that device is designed & manufactured according to ISO 13485 - Evidence of safety, effectiveness & labelling reviewed to validate compliance with MDR. More stringent review than Class III. Premarket regulatory oversight based on licensing system. Market authorization is granted to manufacturers who demonstrate conformity to requirements set out in MDR. Post-market surveillance intended to enforce and promote compliance with MDR Premarket oversight with establishment licensing Post-market surveillance to promote compliance with MDR Risk-Based Regulatory System 13

14. Quality Management System ISO 13485:2003 Quality Management System Certificate Recognized Registrars: BSI (US) Dekra (Netherlands) Intertek (CN) G-MED (France) LRQA (US) NSAI (Ireland) SGS (UK) SAI (Australia) DQS (GER) LGA (GER) TUV-N/S (US) TGA (Australia) UL (USA) TUV (US) 14

15. Application Process – Class II 15

16. Application Process – Class III & IV 16

17. REQUIREMENTS Class I Class II Class III Class IV Medical Device Licence (s.26) (manufacturer) exempt must hold active licence Safety & Effectiveness (s. 10-20) (manufacturer) keep objective evidence keep objective evidence & provide attestation submit objective evidence for review Labelling (s. 21-23) (all parties engaged in importation or sales activities) compliant label (submit for review) compliant label (submit for review) compliant label (submit review) Quality Management System Certificate (manufacturer) exempt ISO 13485 certified (for manufacturing activities) ISO 13485 certified (for design and manufacturing activities) ISO 13485 certified (for design and manufacturing activities) Distribution Records (s. 52-56) (manufacturer, importer & distributor) maintain record Complaint Handling (s. 57-58) (manufacturer, importer & distributor) maintain record Mandatory Problem Reporting (s. 57- 61) (manufacturer & importer) submit preliminary & final report Recall (s. 63-65) (manufacturer & importer) submit recall notice Establishment Licence (s. 44) (class I manufacturer, importer & distributor) must hold active licence must hold active licence (to import/distribute other manufacturers’ devices) must hold active licence (to import/distribute other manufacturers’ devices) must hold active licence (to import/distribute other manufacturers’ devices)

18. Premarket Review Document Requirements 18

19. Classification of Medical Devices To determine the classification of a device, you must apply all of the rules in Schedule 1 of the Medical Devices Regulations. You must consider the labelled indications for use, or claims made for the device. 19

20. Classification of Medical Devices Non In vitro Diagnostic Devices –Large number of variables –Rapid technological advances –Classification criteria based on: The human body Inherent device related potential hazards Customary device use (O.R., I.C.U., N.I.C.U.) 20

21. Definitions “Invasive device” means a medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. “Surgically invasive device” means an invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids. 21

22. Definitions “Central cardiovascular system” means the heart, pericardium, pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, common carotid arteries, cerebral arteries, common carotid arteries, cerebral arteries, brachiocephalic artery, aorta, inferior and superior vena cava, renal arteries, iliac arteries and femoral arteries. “Surgical or dental instrument” means a reusable medical device that is intended for surgical or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting or clipping, without connection to an active device. 22

23. Definitions “Active device” means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. 23

24. Definitions “Active Diagnostic Device” means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. “Active Therapeutic Device” means an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. 24

25. Classification of Medical Devices In vitro Diagnostic Devices (IVDDs) –IVDD means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. –The greater the risk associated with a false positive/false negative, the higher the Class. 25

26. Definitions “Near patient IVDD” means an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional’s office or the bedside. 26

27. Classification? Bandage Antimicrobial Wound Dressing 27

28. Classification? X-Ray Computed Tomography Scanner Portable X-Ray Machine 28

29. Classification? Natural Absorbable Suture X 29

30. Classification? Oral Thermometer X 30

31. Classification? Drugs of Abuse Test Cassette (For laboratory use only) Drugs of Abuse Test Cup (For point of care use) 31

32. Classification? Pregnancy Test 32

33. Overview Class I (low risk) – Class IV (high risk) Pre-market resources apply primarily to Class III & IV Product licensing applies to Class II, III & IV Quality Management System requirements apply to Class II, III & IV Post-market requirements apply to all classes 33

34. Other Regulatory Provisions Part 2: Special Access Programme –Access to custom-made devices (other than mass- produced device) –Access to devices for emergency use or if conventional therapies have failed, are unavailable or are unsuitable –Applications in prescribed format must be received from a health care professional –Authorization for sale granted to manufacturer of the device 34

35. Other Regulatory Provisions Part 3: Investigational Testing –Grants authorization to conduct clinical trials involving human subjects –Applications are received from the manufacturer, including a risk assessment and detailed protocol –Allows manufacturers to acquire evidence of safety and effectiveness as required by Sections 10-20 of the Regulations 35

36. Interesting Statistics 36

37. Interesting Statistics 37

38. Thank You! 38