Non- Compliant Summit

May 8, 201912:00 4:00 pm

Royal York Hotel, Confederation RoomToronto

Dianne GrassiePresident

Agenda

Time

Content

Presenter

12:00 pm

Welcome - Agenda Review

Compliance Act

Dianne Grassie

President DIAC

12:05 pm

Lunch

All

1:05 pm

Introduction of Speakers

Dianne Grassie

President DIAC

1:15 pm

DIAC - Introduction & Non-Compliant Market Advocacy

Rhonda Lawson

1:30 pm

Medical Device Compliance and Enforcement Regulatory Framework

Marc Mes

Director General, Medical Devices and Clinical Compliance Bureau

2:00 pm

Break

All

2:10 pm

Medical Device Establishment Licensing

(MDEL) and Border Enforcement

Anik Chartrand

Director Medical Device Compliance Program

2:30 pm

Medical Device Action Plan

Anik Chartrand

2:50 pm

Prepared Questions

Mat Dinneen, Director DIAC

3:20 pm

Open Q & A

Mat Dinneen

3:45 pm

Close

Rhonda Lawson

Executive Director DIAC

Health Canada

Marc Mes is the Director General of Medical Devices and Clinical Compliance Directorate with Health Canada, responsible for managing the national compliance and enforcement program for medical devices, biologics including blood, cells, tissues and organs, semen, border operations and clinical trials. He leads the planning, delivery (licensing and inspection) and compliance verification activities related to these health products.

Following a career in teaching, Marc began his federal public service career with the Department of Foreign Affairs and International Trade in 2002. He subsequently held positions in Marine Security Policy and Operations at Transport Canada with areas of responsibility including national and international marine security files and inspection and enforcement of ports, marine facilities and vessels within and entering Canadian waters. He then took on the role of Senior Director of Operational Support with the Canadian Coast Guard where he was responsible for the national operations for Coast Guard programs including icebreaking, searchand rescue, environmental response, aids to navigation, marine communications and traffic services, waterways and maritime security.

Marc has also been actively engaged internationally at the International Maritime Organization, in the G8, with the Organization of American States, and was the Chair of the Maritime Security Experts Sub-Group for Asia-Pacific Economic Cooperations Transportation Working Group.

Marc Mes

Director General, Medical Devices and Clinical Compliance Directorate

Health Canada

Health Canada

BUFFETT LUNCH 12:05-1:05

Rhonda LawsonExecutive Director

DIAC Brief Backgrounder

Incorporated 1978 Corporate Membership 105 members Sectors:

Manufacturing, Commercial Laboratories, Distribution and Service

2019 Vision

We will lead as a unified voice shaping the dental industry in Canada.

2019 Mission:DIAC is committed to driving membership success through:

Fostering industry collaboration and creating partnerships; Influencing and communicating regulatory and industry matters; Developing and sharing relevant and impactful industry data; Drive relevant industry education.

EXCERPT FROMCODE OF CONDUCT

To comply with all federal, provincial, municipal, local laws, statutes, regulations, directives, ordinances and without limitation, all other applicable legal requirements applicable to the regulation of the Dental Industry (Governing Laws). For greater certainty Governing Laws include all legal requirements relating to the regulation and governing of the use of facilities, storage and sale of products and service offerings, and the packaging of products by members of the Association.

DIAC - Non-Compliant & Counterfeit Markets

Continues to be a significant issue for the industry, dentists and patient safety

DIAC and members actively engaged in combating non-compliant & counterfeit products.

Tactics to date have made some impact but we need to do more

DIAC Non Compliant Strategy

Advocacy Education Communication

Advocacy Industry leadership

Partnerships and collaboration with all dental industry associations Health Canada, communication and meetings PDC Trade Show oversight, inspection & education Code of Conduct 2013 Buying strategy project Developed protocols for dentists to check product

Example:DIAC Website Non-Compliant Product ProtocolA Suggested Protocol for Checking Product for Dentists: Assign one knowledgeable person to check all product purchases when they arrive in the office Keep all ordering materials (catalogues, flyers etc.) used in ordering the product(s) until the product has been checked in, and keep

the package until the product has been entirely consumed. Manufacturers will be happy to send you a picture of their licensed products and their packaging Check each product when it arrives in the office:

Is it the same product you ordered? Does it have the same name as advertised? Does it have the same product number? Is it the same package that was advertised? Are the contents the same as advertised? (quantity, sizes, shapes, colours etc.) Is the package in English and French? Have any markings been removed/scratched out? Is the product in its original package (or a zip lock bag or other substitute container)? Do the lot number and expiry date on the package match those on the contents? Does the package or contents have markings that indicate it may have been rerouted (e.g. India only or not for sale in North

America) Is equipment CSA approved (or equivalent)?

Example:Overview of the PDC Compliance Verification Process

111 out of 296 exhibitors interviewed by Health Canada

Nearly 100% were in favour of the process

Difficult to determine who was compliant

Education Dealer rep seminars Is It Worth The Risk brochure and campaign Non - Compliant Buying Project Dealer meetings Lectures at PDC/ODA/JDIQ/ODHA

Communication Website protocols and e-blasts Newsletter articles Non-Compliant market postcard campaign Oral Health magazine Attendance at industry functions Messaging and partnering with industry associations Non-Compliant Summit for members

Members Tactics to Minimize Non-Compliant Market Corporate global market strategies Dashboard Price deviation approval process, tracking/reporting

Global Market Strategies Corp.Price Management

Differentiated branding, packaging, delivery system and regulatory registrations for different regions, rationalize offering

Product Differentiation

Unusual low price, on line reporting protocols Unreasonable demand spikes Unusual order & delivery requests

Red Flags Management

Identify the sources of grey market and patterns Take actions to minimize grey market Enforce grey market control plan - online

Product/Lot Tracking

Members Tactics to Minimize Non-Compliant Market Written demands, Cease and desist orders, Trademark and

copyright infringements suits Intellectual property challenges, On line enforcement Guidelines and Controls

Legal

Customers, sales teams and distributors education on products, packaging, Quarterly Innovation Updates,

Differentiated branding, packaging, delivery system and regulatory registrations for different regions

Education

Dedicated team to manage non-compliant and counterfeit products

Trainers and instructors Global Communications, print, social media

Resources

Direct communication with regulators Partnering with CBSA Participation with industry DIAC events and campaigns

Advocacy

21. All Rights Reserved.23 May 2019 3M 3M Confidential.

EXAMPLE: Reducing Avoidable Product Risks E-Course from 3M Health Care Academy.

Course objectives:1. Understand the difference between gray market and counterfeit products. 2. Learn the scope of the problem. 3. Understand how others are fighting back. 4. See the benefits of keeping gray market products out of your practice. 5. Know how to spot gray market products and companies, and what to do.

DO look carefully for authorized distribution channels.

DONT be seduced by hard-to-reach businesses.

EXAMPLE: MARKET UPDATE - April 2018Dentsply Sirona continues the battle against counterfeit and grey market in Canada As you know, the fight against counterfeit goods in Canada is coming to the forefront as consumer reports and lobby groups highlight the seriousness of the problem across all channels of trade. A recent news report focused on counterfeit pharmaceutical products, but the case of professional dental products is no different, in that counterfeit products in the dental supply chain pose a serious health and safety risk to patients and to the general public in Canada and elsewhere.

Dental professionals need to be aware that businesses selling grey market goods are an easy entry point for counterfeit products to infiltrate the legitimate channels of trade and avoid detection. Canada remains on the US Priority Watch List of countries that are considered a major source of counterfeit goods, alongside China, Russia and India. In fact, the Pacific Mall in the GTA was singled out as one of the worst offenders for selling counterfeit products in North America by a recent Fraser Institute report.

31-03-2016 Dentsply Sirona 2016 22

Next Steps: Partner with Health Canada (HC) understand the

organization and implication of the new Medical Devices Action Plan and impact to the industry

Monitor and assist where possible in the development of an industry wide application of enforcement of HC legislation

Advocate, Educate and Communicate to the industry, ensure we support patient centric care and safety through the use of licenced manufacturers, approved products and licenced distributors.

Marc MesDirector General, Medical Devices and Clinical Compliance DirectorateHealth Canada

Anik Michelle ChartrandDirectorMedical Device Compliance ProgramMedical Devices and Clinical Compliance DirectorateHealth Canada

Health Canada Regulatory Operations and Enforcement Branch (ROEB)

Marc Mes, Director GeneralMedical Devices and Clinical Compliance DirectorateRegulatory Operations and Enforcement Branch

Anik Michelle Chartrand, DirectorMedical Devices Compliance Program

Regulatory Operations and Enforcement Branch

Dental Industry Association of Canada Non-Compliant Summit Presentation

May 8, 2019

Presentation Outline1. What is ROEB

Background, Mission, Mandate, Structure Regulatory Oversight of Medical Devices

2. The Medical Devices and Clinical Compliance Directorate Background, Mandate Border Centres Medical Devices Compliance Program

3. Medical Devices Regulation Medical device licensing Medical device inspection Where we are going Medical Device Action Plan Summary, links and contacts

4. Questions and Answers28

ROEB was created in 2016 by centralizing Health Canadas compliance and enforcement to enhance protection of Canadians from the health risks associated with:

Products Substances The environment

We do this by delivering quality compliance and enforcement activities and complementary scientific programs, including:

Field inspections Compliance verifications Compliance promotions Enforcement measures Investigations

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What is ROEB

ROEBs mandate is to . . . Protect the health and safety of Canadians Help Canadians maintain and improve their health Enforce legislation and regulations

ROEB conducts compliance and enforcement activity to monitor the sale, importation and distribution of:

Medical devices (e.g. dental equipment and products) Pharmaceutical and radiopharmaceutical drugs Natural Health Products Blood, donor semen, cells, tissues and organs Other products, such as consumer products and pesticides

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What is ROEB (2)

Regulatory Oversight of Medical Devices

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Regulatory Operations and Enforcement Branch

Medical Devices Compliance Program Establishment licensing, inspection and

compliance verification

Post-market compliance and enforcement

Voluntary and Recall Reports

Health Products and Food Branch

Therapeutic Products Directorate,

Medical Devices Bureau Pre-market medical device licensing

Investigational testing

Special Access Program

Health Products and Food Branch

Marketed Health Products Directorate Post-market surveillance

Mandatory incident reporting

What is the Medical Devices and Clinical Compliance Directorate (MDCCD)

MDCCD is responsible for:

Managing national compliance and enforcement programs that conduct licensing, inspection, compliance verification and outreach activities

Conducting border surveillance and enforcement operations in collaboration with the Canadian Border Services Agency

Ensuring that clinical trial data is accurately and appropriately collected, recorded and stored

MDCCD is continually transforming its operations to be more risk-based and responsive to the global supply chain, to support product innovation and better meet consumer expectations

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How Border Centres Operate

MDCCDs Border Program works with CBSA to determine shipment admissibility.

Commercial and personal importation of medical continue to be a significant part of our program

CBSA refers certain shipments to a Border Centre for admissibility determinations

An Inspector checks the shipment to ensure health products adhere to relevant acts and regulations, including:

Proper labelling Presence of counterfeit or adulterated health products Illegal health products

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Medical Devices Compliance Program Mandate

The Medical Devices Compliance Program (MDCP) manages the delivery of a national compliance and enforcement program for medical devices

Medical Device Establishment Licence Inspections

Medical Device Compliance & Licensing Unit

Medical Device Compliance Verification

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Burnaby

Edmonton

Winnipeg

Toronto

OttawaLongueuil

St. Johns

Halifax

Calgary

Medical Devices Compliance Program Locations

35

Medical Devices Regulation in Canada

Why does Health Canada regulate dental devices and equipment? To ensure medical devices manufactured or imported into Canada meet the safety and effectiveness requirements under The Food and Drugs Act (FDA) and Medical Devices Regulations (MDRs), including:

That dental products are safe and effective Health and safety issues are addressed (e.g. counterfeit, adulterated, or online sale

of unlicensed products) Dental devices are distributed in a traceable manner Problem reporting occurs so Health Canada can track issues and take action

The MDRs: Define the scope of Health Canadas authority Establish that medical devices, including dental devices or equipment, are only for

human use Outline a risk-based classification system for medical devices Set out licensing requirements for medical devices Establish the requirements for the importation, distribution and sale of medical

devices

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Medical devices are categorized into four classes (I, II, III and IV) based on the level of risk associated with their use:

Class I devices present the lowest potential risk Class IV devices present the highest potential risk

For example . . . Class I: Manual toothbrushes, dental floss and dental chairs Class II: Powered toothbrushes, medial gloves and dental drills Class III: Dental cements, dental crowns and dental screws Class IV: Guided tissue regeneration membranes and bone void fillers that incorporate animal tissue

derivatives for dental treatment

Medical Device Licensing in Canada

37

Medical Device Licence(MDL)

Medical Device Establishment Licence (MDEL)

Issued to Manufacturer of Class II, III, or IVdevicesManufacturer of Class I devices andimporter or seller of Class I-IV medicaldevices for human use in Canada

Issued byMedical Device Compliance andLicensing Unit (MDCLU), RegulatoryOperations and Enforcement Branch,Health Canada

The Medical Devices Bureau(MDB), Health Products andFood Branch, Health Canada

There are two types of licences issued by Health Canada for medical devices sold in Canada:

Medical Device Licensing in Canada (2)

38

MDELs are issued to establishments that: Import or distribute any class of medical device in Canada Class I medical device manufacturers There are currently over 3,000 MDEL holders (more than 2,000 domestic

and over 850 foreign)

MDEL holders must submit an Annual Licence Review (ALR) application each year, before April 1

The purpose of the annual review is to ensure continued regulatory compliance and to maintain up-to-date information on each establishment

Health Canada is working to change the MDEL fee structure In the new structure, it is envisioned that regulatory fees will be updated to

better reflect current costs

Medical Device Establishment Licences

39

Health Canada inspects domestic and foreign MDEL holders that: Manufacture Class I medical devices Import and/or distribute Class I IV medical devices

Health Canada inspections are conducted on-site (domestic and foreign) and virtually (video/teleconference, electronic file review) and assess compliance with the FDA and MDR.

The Medical Device Single Audit Program (MDSAP) inspects domestic and foreign establishments that:

Manufacture Class II - IV medical devices

The MDSAP audits based on the ISO:13485 Standard.

Medical Devices Inspections

40

Top Four Deficiencies Found on Inspection

Establishment Licensing

Incorrect information on MDEL Application (e.g. incorrect activities, inadequate manufacturers, incorrect class of devices sold)

Complaint Handling, Recall,

Mandatory Problem Reporting

Procedures

Inadequate procedure, missing information, insufficient information to ensure compliance with regulations

Labelling Missing information on label, does not match Health Canada Device Licence

Device Licensing Unlicensed devices

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Where Are We GoingHealth Canadas Compliance & Enforcement Policy for Health Products (POL-0001)

Updated

December 21, 2018

Strengthened Enforcement

To better protect Canadians

EnforcementMeasures

Include, but not limited to:Stop Sale Notification

Mandatory RecallBorder Refusals

Licence CancellationProduct Seizure

Prosecution

Available on Health Canadas website https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-health-products.html

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https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-health-products.html

MDEL Regulatory Review Our present regulatory system needs improvement to:

Be more efficient Support timely access to therapeutic products Build better linkages within the health care system

For example, Health Canada proposes to modernize regulations to include a regulatory sandbox for new and innovative products, such as: Tissues developed through 3D printing Artificial intelligence Gene therapies targeted to specific individuals

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Where Are We Going (2)

Health Canadas Action Plan on Medical DevicesWhat is the goal of Health Canadas Medical Devices Action Plan (MDAP)?To enhance the safety and effectiveness of medial devices and to optimize health outcomes for patients

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Provide more information to Canadians

Strengthen monitoring and follow-up

Improve how devices get on the market Increase research by medical professionals and increase patient protection Review evidence requirements for medical device approvals Expand the use of outside experts and build our internal expertise Strengthen oversight of quality manufacturing of medical devices

Improve reporting of incidents by healthcare institutions Expand the scope of the Canadian Medical Devices Sentinel Network (CMDSNet) Establish ability to compel information from manufacturers on medical device safety and effectiveness Strengthen the use of real-world evidence Enhance capacity in inspection and enforcement

Improve access to medical device clinical data Publish review decisions on higher risk medical devices Publish medical device incident data Provide open access to medical device inspection results

Guidance Documents and LinksMedical Devices Regulationshttp://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Guidance Document on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016)https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-medical-device-establishment-licence-fees-guide-0016.html

Medical Device Establishment Licence Application Form and Instructionshttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

Guidance Document on How Health Canada Inspects Medical Device Establishments (GUI-0064)https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html

List of All Medical Device Establishment Licence Holdershttps://health-products.canada.ca/mdel-leim/index-eng.jsp

General Information on Medical Device Establishment Licensinghttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html

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http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-medical-device-establishment-licence-fees-guide-0016.htmlhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.htmlhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.htmlhttps://health-products.canada.ca/mdel-leim/index-eng.jsphttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html

Contact information

Medical Device Establishment Licences: hc.mdel.questions.leim.sc@canada.ca

Invoicing and Fees: hc.criu-ufrc.sc@canada.ca

Medical Devices Classification, Labelling, Clinical Trials and MDLs: hc.mdb.enquiries-enquetes.bmm.sc@canada.ca

Medical Device Compliance and Disputes (including required records, complaint handling, problem reporting, recalls, inspections and licensing): hc.mdcu-ucim.sc@canada.ca

To submit a voluntary complaint involving a medical device, please visit: http://healthycanadians.gc.ca/apps/radar/MD-IM-0005.08.html

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mailto:hc.mdel.questions.leim.sc@canada.camailto:hc.criu-ufrc.sc@canada.camailto:hc.mdb.enquiries-enquetes.bmm.sc@canada.camailto:hc.mdcu-ucim.sc@canada.cahttp://healthycanadians.gc.ca/apps/radar/MD-IM-0005.08.html

Questions?

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Mat Dinneen, DirectorChair, Regulatory Subject Matter

Committee

PREPARED QUESTION & ANSWERS

AUDIENCE OPEN QUESTIONS AND ANSWERS

Rhonda LawsonExecutive Director

Closing Comments

Non- Compliant SummitSlide Number 2AgendaSlide Number 4Health CanadaSlide Number 6Slide Number 7DIAC Brief Backgrounder2019 Vision2019 Mission:EXCERPT FROMCODE OF CONDUCTDIAC - Non-Compliant & Counterfeit MarketsDIAC Non Compliant Strategy AdvocacyExample: DIAC Website Non-Compliant Product ProtocolExample:Overview of the PDC Compliance Verification ProcessEducationCommunicationMembers Tactics to Minimize Non-Compliant Market Members Tactics to Minimize Non-Compliant Market EXAMPLE: Reducing Avoidable Product Risks E-Course from 3M Health Care Academy. Slide Number 22Next Steps: Slide Number 24Slide Number 25Slide Number 26Health Canada Regulatory Operations and Enforcement Branch (ROEB)Presentation OutlineSlide Number 29Slide Number 30Regulatory Oversight of Medical DevicesWhat is the Medical Devices and Clinical Compliance Directorate (MDCCD)How Border Centres OperateMedical Devices Compliance Program MandateMedical Devices Compliance Program LocationsMedical Devices Regulation in CanadaMedical Device Licensing in CanadaMedical Device Licensing in Canada (2)Medical Device Establishment LicencesMedical Devices InspectionsTop Four Deficiencies Found on InspectionWhere Are We GoingSlide Number 43Health Canadas Action Plan on Medical DevicesGuidance Documents and LinksContact informationQuestions?Slide Number 48Slide Number 49Slide Number 50Slide Number 51