Medical Device Regulations in Canada; Key Challenges and International Initiatives

2 Goals of Regulatory System in Canada Risk based approach Post-market surveillance Global Harmonization International standards Quality systems approach Transparency and communication

REGULATORY SCRUTINY INCREASES WITH RISK Post Market -Quality Systems - Licensing -Quality Systems -Licensing Premarket Review Class I Class II Class III & IV Lower Medium Highest

Health Canada’s Regulatory Model for Medical Devices Regulatory Audit - Registrars Quality Management System/ Risk Management - Manufacturers Safety and Effectiveness Requirements for all device Classes Class II (NO STED submitted) Class III (premarket document/STED) Class IV (premarket document/STED) License Amendments Licensing Postmarket Premarket Regulatory Oversight and Enforcement Complaint Management Maintenance & Service Corrective and Preventive Actions Postmarket Clinical Follow-up~licensing conditions HHE- licence suspension

Regulatory Provisions - Essentials A manufacturer in the Regulations: – 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 5

Regulatory Provisions - Essentials 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 6

Current Context and Challenges Rising health care costs and budget constraints Fast paced technological development Erosion of public confidence and pressures to toughen regulatory systems The informed patient consumer Increasing focus on HTAs and regulatory interface 7

Current Context and Challenges – Pace of Technological Change R&D generates competitive edge for device companies, as in other industries Unlike drug world, however, device sector develops new products faster, with shorter life cycles Rate of innovation, shorter review timelines and greater diversity/complexity of technologies pose increasing regulatory challenges 8

Current Context and Challenges – Globalisation Increased complexity of global supply chain Higher number of suppliers, with more frequently considered ‘assemblers’ Increased use of countries without regulatory systems as manufacturing sites Differentiation between local/international, emerging/developed markets Growing demands for regulatory convergence 9

Increasing International Collaboration Canada’s regulatory framework for medical devices has harmonized portions with those of the FDA and EU Allows for opportunities for co-operation and possible convergence Quality systems has been identified as a suitable area for international convergence 10

Medical Device Single Audit Program (MDSAP) Vision: To develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions Long term goal: international coalition of countries dedicated to pooling technology, resources and services to improve safety and oversight of medical devices in a more efficient manner that is also less burdensome for industry Modelled after Health Canada’s CMDCAS third party program; draws upon best practices of Canadian and American systems FDA, Health Canada, Therapeutics Goods Administration (Australia) and ANVISA (Brazil) signed a Statement of Cooperation (November 2012) to commit to the development and operation of this program. 11

Medical Device Single Audit Program (MDSAP) To enable the appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry. To promote, in the longer term, greater alignment of regulatory approaches and technical requirements globally based on international standards and best practices To promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. 12

MDSAP - Elements Initial Recognition, Surveillance, and Re-Recognition Criteria for MDSAP Recognized Auditing Organizations (IMDRF Lead) Standardized Recognized AO Auditor Competency and Competency Maintenance Requirements (IMDRF Lead) Standardized Regulatory Authority Assessor Competency and Competency Maintenance Requirements (IMDRF Lead) Regulatory Assessment Program and Assessment Strategy for the Recognition and Monitoring of Medical Device Auditing Organizations (IMDRF Lead) 13

MDSAP - Elements Standardized Audit and Assessment Models Auditing of a Manufacturer by an MDSAP Recognized AO Assessment of MDSAP Recognized AO’s by participating Regulatory Authorities Standardized Rating System for Manufacturer Audit Findings Standardized Rating System for Recognized Auditing Organization Assessment Findings MDSAP Quality Management System 14

IMDRF -Medical Device Single Audit Program (MDSAP) The IMDRF Work Group is working on various components of the MDSAP model The Work Group will develop a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers. The documents will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. 15

MDSAP Manufacturer Audit Criteria ISO 13485: Specific Requirements of: TGA ANVISA HC _______ FDA________ = One Comprehensive Audit Model 16

MDSAP Manufacturer Audit Cycle The Medical Device Single Audit Program is based on a three (3) year audit cycle. The Initial Audit, also referred to as the “Initial Certification Audit” is a complete audit of a medical device manufacturer’s quality management system (QMS) consisting of a Stage 1 Audit and a Stage 2 Audit. The initial Audit is followed by a partial Surveillance Audit in each of the following two (2) years and a complete Re-audit, also referred to as a “Recertification Audit” in the third (3rd) year. Special Audits, Audits Conducted by Regulatory Authorities, and Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle. 17

MDSAP Pilot January 1, Recognition of initial participating Auditing Organizations June 1, 2014 – some Auditing Organizations ready to start auditing medical device manufacturers and more will be added as the pilot progresses. 18