Medical Devices Program Update

Transcription

1 Medical Devices Program Update Cindy Evans Interim Senior Executive Director Therapeutic Products Directorate Health Products and Food Branch April 29, 2015

2 Classification of Medical Devices Medical Device Regulations set out a system for classifying medical devices into one of four classes. Class I Class II Class III Class IV Low Risk Moderate Risk High Risk Increasing Regulatory Oversight 2

3 Regulatory Framework Overview Class I (low risk) Class IV (high risk) 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 Establishment Licensing applies primarily to importers/distributors/class I manufacturers Percentage of Devices on Market Class IV Class III Class II Class I 3

4 Delivery of the Medical Devices Program Health Products and Food Branch (HPFB) Therapeutic Products Directorate (TPD-MDB) Marketed Health Products Directorate (MHPD) Health Products and Foods Branch Inspectorate (HPFBI) Regions and Programs Bureau (RAPB) Halifax, Longueuil, Toronto, Winnipeg, Edmonton, Burnaby 4

5 Medical Devices Program Performance 5

6 Therapeutic Products Directorate Medical Devices Bureau Including data up to March 31,

7 Class II Applications Received and Licences Issued 7

8 Class III Applications Received and Licences Issued 8

9 Class IV Applications Received and Licences Issued 9

10 10

11 11

12 12

13 # Dec

14 14

15 15

16 16

17 Health Products and Food Branch Inspectorate (Includes data up to Dec 31, 2014) 17

18

19

20

21

22

23

24 Marketed Health Products Directorate

25 25

26 # Voluntary Medical Device Problem & CMDSNet Reports * Source MDS/Repository stats as of Feb 28/15 26

27 Requests for Additional Information and Screening Deficiencies 27

28 28

29 Most Common Additional Information Requests Class III and IVDD IV Devices New and Amendment Applications Safety and Effectiveness Studies Device Labels, Package Labelling and Documentation Background Information Marketing History/Regulatory Status 29

30 Most Common Screening Deficiencies Class III and IVDD IV Devices New and Amendment Applications Safety and Effectiveness Studies Background Information Fees Device Labels, Package Labelling and Documentation Manufacturing Quality Controls Licensing Also for Non-IVD Marketing History/Regulatory Status 30

31 Application Quality Report Card launched in April 2014 Objective: Provide feedback to applicants on quality of applications Help manufacturers ensure that future applications are of the best quality Improve the timeliness of MDB s review process Reduce the number of Requests for Additional Information 31

32 Quality Report Card: Initial Outcomes 100% All Sections (July to February 90% 80% 70% 60% 50% 40% 30% POOR ACCEPTABLE EXCELLENT 20% 10% 0% 32

33 Quality Report Card: Initial Observations Quality of submissions has stayed relatively consistent Most applications submitted are of acceptable quality For each category, there are approximately 10% of applications with poor quality information Overall, approximately 20% of applications received at least one rating of poor in one of the categories listed. There remains opportunity for manufacturers to improve the quality of submissions 33

34 List of Recognized Standards for Medical Devices Updated on Health Canada s website Recent update posted New update to be posted very shortly for consultation Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations 34

35 Special Access Programme: Draft Guidance Document A draft guidance document for health care professionals on special access and custom-made medical devices was distributed via to active health care professionals, industry stakeholders, MEDEC, and the Canadian Medical Association for comment in late March, with a 60 day consultation period This guidance document is intended for health care professionals seeking Special Access to a medical device The guidance document: clarifies the mandate, intent and scope of the Special Access Programme outlines the responsibilities of the health care professional, manufacturers and Health Canada in the process. 35

36 Transparency - Regulatory Decision Summary Starting in April 2015, the Medical Devices Bureau will be publishing Regulatory Decision Summaries (RDS) A document summarizing positive licensing decisions for class IV medical devices in Phase I Eventually will be published for all positive licensing decisions The RDS will include basic information about what was licensed and a brief summary of information that was reviewed to come to a licensing decisions The RDS will be approximately 1 page in length 36

37 Application Formats Pre December 1, 2014 No standardized format Accepting electronic AND paper premarket review documents Post December 1, prescribed formats (STED, HC, ToC) Accepting electronic only premarket review documents Desired Future state Implement a standard, internationally harmonized, submission structure for Class III and IV medical device licence applications (IMDRF ToC) Move to fully electronic review environment 37

38 TOC Implementation Pilot Pilot Objectives: Gain experience with the ToC and develop HC guidance Provide input to IMDRF for consideration in their pilot Milestones: October 2014 invitation to participate in pilot was sent November 2014 pilot began, 26 companies September 2015 target end date for pilot As of April 7, 2015 manufacturers of 15 applications have notified of their intent to submit: 4 not yet received, 5 in screening, 5 in review queue, 1 under review 38

39 Medical Devices Single Audit Program (MDSAP) Designed and developed to provide a single efficient audit of the medical device manufacturers while ensuring coverage of all of the jurisdictions requirements (Australia, Brazil, Canada & USA) in a regulatory audit Currently seven Auditing Organizations have applied, and seven manufacturers are participating in the pilot Medical device manufacturers interested in the program should contact the Auditing Organization of their choice to determine if they are - or when they expect to be - authorized to perform MDSAP Pilot audits. HC link: FDA link: 39

40 Commercial Reprocessing of Single Use Devices In February 2015, Health Canada announced its regulatory approach to begin regulating commercial reprocessors of medical devices originally labelled for single use. Companies that reprocess and distribute medical devices originally authorized and labelled for single use to Canadian healthcare facilities will be subject to the Regulations. 40

41 Commercial Reprocessing of Single Use Devices These companies must meet the same requirements as current licence holders, including the following: Licensing Quality Management System (QMS) Conducting Recalls Mandatory reporting of incidents Inform Health Canada of any changes to the information in their licence application 41

42 Transition Period By September 1, 2016 all commercially reprocessed single use devices are expected to be in compliance with the Regulations. Health Canada is meeting with manufacturers and industry associations to promote awareness of the regulatory requirements. Health Canada has currently licensed one reprocessed single use device (compression sleeve). 42

43 Questions? 43

44 Additional Background on the Medical Devices Program and Regulatory Framework 44

45 Brief History 45

46 Quality Management System ISO 13485:2003 Quality Management Systems Certificate Recognized Registrars: BSI Group America (US) Intertek (CN) LRQA (US) SGS (UK) Dekra (Netherlands) G-MED (France) NSAI (Ireland) SAI (Australia) DQS (GER)TÜV-NORD (GER) TGA (Australia) UL (USA) TÜV SÜD (US) TUV Rhineland (US) TUV USA (US) 46

47 Special Access Programme Overview Part 2 of the Medical Devices Regulations, the Special Access Provisions, permits health care professionals to access custom-made and/or unlicensed medical devices for: Emergency Use, or Conventional Therapies have: Failed, or Are unavailable, or Are unsuitable 24/7 Service for health care professionals across Canada ~ 6000 applications received annually ~ 610 unique medical devices requested in

48 Industry Role & Regulatory Obligations: Pre-SAP approval Health Care Professional completes and submits an application The manufacturer should NOT complete any portion of the medical rationale section of the application form, including handing out pre-filled template applications to health care professionals (even if the health care professional asks for one) Health Canada may contact the manufacturer to request technical information about a medical device requested under the SAP. Please respond as soon as possible, bearing in mind that Health Canada must have sufficient time to review information prior to granting an authorization. Unlicensed devices accessed under SAP cannot be advertised or otherwise promoted (even if previously authorized at the same facility under SAP) Successful RFP contracts cannot be fulfilled under the Part 2 provisions A Special Access Authorization must be granted prior to importation OR sale (distribution) Ultimate decision to provide requested device lies with the manufacturer 48

49 Industry Role & Regulatory Obligations: Post-SAP approval Unique Authorization for Importation and/or Sale An authorization is valid for importation and/or sale not to exceed the quantity of devices specified. An authorization is not valid for successive purchases. Labelling Labelling For Special Access Use Only must be present on the SAP-approved medical device prior to importation and sale Distribution Records Distribution records must be maintained, according to sections 52 to 56 of the Regulations Adverse Events Adverse Events should be reported to MHPD using the industry reporting form Recalls Voluntary recalls of SAP-approved medical devices should be communicated directly to the Special Access Programme Licensing Authorizations through the SAP are not to be used as circumvention of licensing requirements. Requests may be refused if it appears that the manufacturer does not intend to license their device. 49