Establishment Licensing & Inspection Process

Transcription

1 Establishment Licensing & Inspection Process MEDEC Regulatory Conference May 11, 2016 Mark Bailey, Compliance Specialist Medical Devices Inspections, Central, Health Canada Collin Pinto, Manager Medical Devices Compliance and Establishment Licensing Unit, Health Canada

2 Presentation Overview Part A: Inspection Program Inspection Overview and Results Best Practices: Making the Inspection Run Smoothly Common Inspection Issues Inspections Going Forward Part B: Establishment Licensing Non-Compliant (NC) Rating and Licence Suspension Process Common Application Issues 2

3 Part A: Inspection Program Inspection Overview and Results Best Practices: Making the Inspection Run Smoothly Common Inspection Issues Inspections Going Forward 3

4 MDEL Inspection Program Overview As of April 2016, there were over 2,700 MDEL holders: 1,900 domestic 800 foreign Inspections are conducted by regional Inspectors located across the country Domestic inspections follow the current inspection cycle: 3 years Manufacturer 4 years Importer 5 years Distributor 4

5 Inspection Results 5

6 Inspection Best Practices Question: How can I make the inspection run as smoothly as possible? 6

7 Inspection Best Practices Scheduling the Inspection: The Inspector will contact you with specific dates, which are determined by the inspection cycle Inspectors will generally give two weeks notice of inspection dates If you are unavailable for the proposed dates, provide a reasonable alternative A rationale is required in order to change/defer the dates Changes are exceptions; not all requests will be accommodated 7

8 Inspection Best Practices Inspection Preparation: Request an inspection plan/schedule which outlines the specific areas covered (if not already provided) If you have any questions about the inspection process, request a phone meeting prior to the inspection If multiple sites are part of the MDEL, provide the Inspector with a breakdown of documents/products/company personnel at each site 8

9 Inspection Best Practices Inspection Preparation (continued): Submit all requested documents by the date indicated in the Notice of Inspection Letter Review documents that will be subject to inspection: SOPs, Recall/Mandatory Reports, complaint files Ensure required information can be retrieved from databases in a timely manner: Distribution records, complaint logs, etc. Review past inspection reports to ensure any issues from previous inspections have been addressed 9

10 Inspection Best Practices Onsite Inspection Portion: Have all relevant personnel available for the opening meeting Review and discuss the inspection plan with the Inspector Ensure all documents (electronic and/or hard copy) are readily available Ensure any subject matter experts located off-site are readily available by phone or 10

11 Inspection Best Practices Onsite Inspection Portion (continued): Request a summary at the end of each inspection day Ensure any corrections or corrective/preventive actions completed during the course of the inspection are effective During the closing meeting, ensure that all Observations noted in the Draft Inspection Report are understood 11

12 Inspection Best Practices Following The Inspection: If Observations are noted, complete any corrections or corrective/preventive actions in a timely and effective manner Contact the Inspector if any Observations noted in the Final Report are unclear Provide a detailed action plan to address each open Observation Provide documentation to support any actions that have been taken 12

13 Common Issues Question: What common issues are currently being found during MDEL inspections? 13

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15 Device Labelling (MDR S. 21) If multiple company names and addresses appear on the label, the role of each company must be clear If only one company s name and address appear on the label, they are considered the manufacturer Manufacturer name and address must be in sufficient detail to serve as a postal address (minimum: name, city, province/state and postal/zip code) Manufacturer name and address on the label must match information listed on the Medical Device Active Licence Listing (MDALL), Health Canada must be notified of label changes/transitions. If your proposal is accepted, you will receive an acknowledgement 15

16 Device Licensing (MDR S. 26) The inspector may review any devices available for sale Device licences always are verified via the Medical Device Active Licence Listing (MDALL), found at Particular attention should be given to ensure that all current device identifiers are listed under licences Health Canada must be notified of licence changes/transitions If the device has been classified by the Medical Devices Bureau, have this documentation available 16

17 Advertising (MDR S. 27) Where unlicensed devices are advertised, there must be a clear and visible warning indicating that not all devices may be licensed The Inspector may also review the controls in place to prevent Canadian customers from having access to international catalogues or ordering devices online Advertising of devices as available through Special Access is prohibited 17

18 Documented Procedures (MDR S. 45 & 58) The Inspector reviews all applicable procedures to ensure they are established and implemented The evaluation of effectiveness is done by interviewing company personnel involved and reviewing related records and databases Referencing the Regulations and Guidance Documents in a procedure may be an acceptable practice, but the procedure must still be effective and company personnel must still be able to follow it In cases where personnel have limited regulatory knowledge/experience, a more detailed listing of regulatory requirements may be needed 18

19 Distribution Records (MDR S ) The Inspector may sample records for any type of device, including devices sold as samples, loaners, rentals and consignment inventory Records include receipt of product from manufacturer or supplier, inventory storage information, and shipments to customers The Inspector performs inventory reconciliation for at least one device, by verifying that quantity of devices received, matches quantity shipped and that the amount in current inventory 19

20 Complaint Records (MDR S. 57) The Inspector reviews complaint records in order to verify that the documented procedure has been implemented and that complaints are being investigated in a timely and effective manner Records should indicate all actions taken in response to complaints Complaints received should be reviewed against Mandatory Problem Reporting and Recall criteria Servicing, Return Merchandise Authorization (RMA) or warranty files may also be reviewed, as some of these issues may be considered complaints 20

21 Mandatory Problem Reporting (MDR S ) The Inspector reviews this section along with complaint handling, to evaluate whether incidents reported are being reviewed against Mandatory Problem Reporting criteria Mandatory Problem Reports submitted are reviewed to confirm that the reports are submitted within the required timelines and contain the required information There is no provision in the Regulations for manufacturers to report on behalf of importers; importers must always report 21

22 Recall Reporting (MDR S. 64 & 65) The Inspector will request a list of recalls conducted Recall files are reviewed to confirm that the reports were submitted within the required timelines, and that reports submitted contain the required information There is no provision in the Regulations for manufacturers to report recalls on behalf of importers; importers must always report 22

23 Custom-made/Special Access (MDR S. 70, 75, 76) Authorization files, including distribution records, are sampled, to verify that authorizations were received prior to importation and sale of devices Full traceability of devices must be demonstrated Device labels are reviewed to verify compliance with the labelling requirements in S. 75(a)-(c) 23

24 Inspections Going Forward Question: What changes can we expect from the Inspection Program? 24

25 Current Inspection Cycle Inspections are based on site activity: 3 Years Manufacturer - Class I 4 Years Importer - Class I, II, III, IV 5 Years Distributor - Class I, II, III, IV Advantages Fail-safe procedure for all companies to be inspected within a specified deadline Disadvantages For regular inspections, every company is treated equally regardless of compliance history Does not scale with the growing demand for inspections We currently have three separate cycles operating at the same time 25

26 Proposed Inspection Cycle based on Risk Site Risk Profile The concept of rating a site/company/facility on the basis of an estimated risk that the organization s products, processes and compliance history may pose to consumers/users Examples of risk profiling in use: Insurance (to determine rates) Hospital, health care settings (wait times, elective surgery, etc.) Public Health (infectious disease outbreaks, prevention & promotion programs) Canada Revenue Agency (compliance, fraud) Transport Canada (compliance & surveillance) 26

27 Proposed Inspection Cycles based on Risk Development of an inspection planning approach to prioritize inspections based on a set of risk factors Some risk factors under consideration include: Activity, Device classes sold, Number of previous Compliant or Non-Compliant inspections, Previous Risk Ratings of Observations We are working on the development of a statistically validated site risk profile model which uses historic inspection data to estimate the relative risk of sites, given a set of contributing factors Continuous evolution with the site risk profile, based on on-going data collection and analysis to provide improved risk assessment over time 27

28 Part B: Establishment Licensing Non-Compliant(NC) Rating and Licence Suspension Process Common Application Issues 28

29 NC-Rating and Licence Suspension Process We have reviewed the process to suspend or not issue a licence after a site has been rated Non-Compliant (NC) The objectives of the review were to: Ensure that the process is conducted in a consistent and timely manner Improve procedural fairness for stakeholders Improve our communications with stakeholders 29

30 Inspection Overview Immediate Risk to Health Assessment Assess whether the observations leading to an NC-Rating are an immediate risk to health Inspection rating Document, synthesize and communicate the inspection findings and finalize in the form of a site rating Opportunity to be Heard Provide the licence holder with an opportunity to be heard further to a proposal to suspend or proposed non issuance of the licence Decision Internal hearing to consider all relevant information and analyse options regarding the licence 30

31 Immediate Risk to Health Assessment Overview When an immediate risk to health is identified: the process to suspend the licence is immediately started the licence suspension can happen before the inspection report is finalised and the rating is issued. After the immediate suspension the site rating is issued: There is an opportunity to be heard the licence holder. 31

32 Overview Inspection rating Inspection completed Unrated draft inspection report and letter from inspector are sent Review of report by national committee (Inspection Risk Rating Group) NC-rated inspection report and letter from inspector 32

33 Overview Opportunity to be heard (OTBH) Information that the Minister may consider in its decision regarding the licence status. For example: What impact will licence suspension have on the health and safety of Canadians? Could licence suspension cause a shortage in Canada of a product that is both medically necessary and has no available alternatives? Has the company submitted an adequate corrective action plan? 33

34 Overview Decision Information available to Health Canada Suspend Licence Assess and recommend Record of decision Information provided by Licence Holder (CAPA, OTBH) Maintain Licence 34

35 MDEL Application Issues - Sites Site: a site is any additional building (from the same corporation/legal entity as the applicant) where the activities and attested to procedures are in place If a site is located in a different country than the main physical address, it cannot be listed as a site and will likely require its own MDEL A commercial warehouse would not require an establishment licence if it only provides storage service and does not purchase, accept products on consignment, or enter into contracts for the sale of medical devices A P.O. Box is not considered an acceptable licence address site 35

36 MDEL Application Issues - Activities Difference Between Importers and Distributors: Distribute medical devices from a supplier that is outside of Canada Importer only Distribute medical devices from a supplier in Canada Distributor only Distribute some devices from outside Canada, and some from in Canada Importer and Distributor 36

37 MDEL Application Issues - Changes Amendments and Notifications Licence holders are required to notify the Minister within 15 days of: a change to the name or address of the licence holder a change to the name, title or telephone number of the contact person All other changes (new manufacturers, new sites, etc.) are submitted via the Annual Licence Review If necessary, an amended licence will be issued that reflects the changes Include six digit company ID and MDEL# on all communications (preferably in your subject line). This will help to expedite response time 37

38 MDEL Questions and Inquiries: Best Practices Do not send the same inquiry to multiple inboxes Do not leave the same message in the same inbox multiple times instead of phone when possible Mention your MDEL# and six digit Company ID in your message/inquiry, along with the nature of your inquiry Direct any billing / fee inquiries to: ELIU_UFLE@hc-sc.gc.ca 38

39 Questions? 39

40 Contact Information Mark Bailey Compliance Specialist Medical Devices Inspections, Central Regulatory Operations and Regions Branch (RORB) Health Canada Collin Pinto Manager Medical Devices Compliance and Establishment Licensing Unit Regulatory Operations and Regions Branch (RORB) Health Canada

41 Thank you! Merci! 41