Medical Devices Program: Strategic Plan 2007-2012: Building for the Future

Date: 2007-06-07

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Table of Contents

MESSAGE FROM THE DIRECTORS GENERAL

INTRODUCTION

THE MEDICAL DEVICES PROGRAM AT HEALTH CANADA
The Health Products and Food Branch
The Medical Devices Program

CHALLENGES AND OPPORTUNITIES
The Industry Environment
The Regulatory Environment and Program Pressures

MOVING FORWARD

OUR VISION

STRATEGIC OBJECTIVES

MEETING THE CHALLENGE
Regulatory and Program Modernization
Human Resources - The Right People to Get the Job Done
Stable Adequate Funding
Governance and Business Transformation
Sound Partnerships, Effective Relationships and Open, Transparent Communications

MEASURING SUCCESS

MESSAGE FROM THE DIRECTORS GENERAL

Health Canada has a strong regulatory program for medical devices. Canadians can be confident that medical devices sold in this country are safe, effective and of high quality. However, the Medical Devices Program has faced a number of challenges over the past decade not the least of which were the eight recommendations most recently outlined in the Auditor General's 2004 Report to Parliament.

The Auditor General's report has been a catalyst for change and has enabled us to focus on making incremental enhancements to prepare for the future. The Auditor General recognized that "medical devices play an important role in all stages of delivery of health care." Responding to the Auditor General's report and recommendations has provided us with the opportunity to take a critical look at the way we do business and take action to enhance and improve the program.

We need to be responsive, proactive and strategic. We need to get ahead of the issues before they impact us. Our commitment to working together, sharing our knowledge and continuously furthering our expertise will enable us to continue in the right direction.

The program has made recent progress by eliminating the pre-market review backlog and achieving 81% of decisions within target for all Class II, III and IV applications in 2006, making medical devices accessible to the Canadian market in a timely manner. Continued improvements to our post-market surveillance and inspection programs have ensured that medical devices continue to be in compliance of the Medical Devices Regulations and safe for Canadians.

We believe the Medical Devices Program Strategic Plan Building for the Future helps us define our future direction. It emphasizes our commitment to improving our work environment and ensuring the strategic management of our resources. Building for the Future is a "living" document that will evolve as we achieve our goals and respond to emerging trends, challenges and opportunities.

Thank you to all those involved for helping and contributing to this document that will move the program to the next level and enable us to meet the challenges of the future.

It is with great pleasure that we welcome you to join us on this exciting and rewarding journey.

Supriya Sharma, Therapeutic Products Directorate
Diana Dowthwaite, Health Products and Food Branch Inspectorate
Chris Turner, Marketed Health Products Directorate

INTRODUCTION

Over the past 15 years the Medical Devices Program (MDP) has been evolving to meet the needs of Canadians. A 1992 Report by the departmentally commissioned Medical Devices Review Committee began a course of reform within the program leading to the introduction of new regulations in May 1998 which came into force in July of that same year. These regulations set out classifications for medical devices and put in place procedures for review and licensing.

Canada has a strong regulatory program for medical devices. Canadians can be confident that medical devices sold in this country are safe, effective and of high quality. However, scientific and technological advances and a rapidly changing health care environment have led to an exponential increase in the number of new devices being developed and submitted to Health Canada for review. Canadians have high expectations for more and better devices to meet their needs. They expect a program, delivered by Health Canada, that will improve their health and minimize the risks associated with the devices that are made available to them through the health care system. Health care professionals expect that new technologies will be available for them to provide ever advancing levels of quality care to their patients.

In order to keep up with the pace of change, the Medical Devices Program must continue to plan for the future and ensure that it has the most appropriate system in place to allow Canadians to safely benefit from the medical devices of the future. Building for the Future has been prepared based on input by the staff and management of the Medical Devices Program in the Health Products and Food Branch of Health Canada. It lays out the program's vision and strategic plan for five years - from 2007 to the end of 2012.

The Medical Devices Program is managed through the Health Products and Food Branch of Health Canada. Working with a budget of just over $11 million and approximately 150 full-time employees in the fiscal year 2005-2006, the program monitors and evaluates the safety, efficacy and quality of diagnostic and therapeutic medical devices so that consumers and health care professionals can use them with confidence. Building for the Future is an exploration of the outstanding challenges faced by the program, potential means of meeting these challenges and a roadmap that will lay the groundwork for the future of the program.

The plan outlined here is not an end in itself. It provides another important building block in a process that will continue to involve Canadians, stakeholders, industry and health care professionals to ensure that the program is able to grow and evolve to meet the ever-changing demands of the health care environment.

THE MEDICAL DEVICES PROGRAM AT HEALTH CANADA

The Health Products and Food Branch

The Health Products and Food Branch (HPFB) of Health Canada has a budget of $275 million and close to 2400 employees. Its mandate is to take an integrated approach to the management of the benefits and risks related to health products and food by:

• minimizing health risk factors to Canadian while maximizing the safety provided by the regulatory system; and
• promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

To support its mandate, the HPFB has articulated a 2007-2012 Strategic Plan and a Blueprint for Renewal to help guide the modernization of the Canadian regulatory health system and achieve its vision as an internationally recognized regulatory leader.

A number of objectives and initiatives being advanced under the HPFB Strategic Plan and the Blueprint for Renewal will help inform the action plan to strengthen the Medical Devices Program:

• regulatory interventions proportional to risk;
• strengthening safety oversight through the adoption of life cycle
• approaches;
• improving pre-market review performance;
• strengthening post-market surveillance and compliance/enforcement;
• long-term sustainability of the program through the renewal of the Cost Recovery regime.

The HPFB is also undertaking a Branch-wide Comprehensive Review of Programs and Resources aimed at ensuring that the HFPB has adequate capacity and resources to deliver on its mandated activities, as well as the development of a new Cost Recovery regime. The specific needs of the Medical Devices Program are being considered as part of these initiatives.

The Medical Devices Program

The Medical Devices Program is co-managed by three Directors General within the Health Products and Food Branch. A coordinating committee was created at the Director General level to review the recommendations, develop appropriate responses and monitor the progress to address all of the Auditor General's 2004 recommendations. This coordinating committee continues and provides a forum for discussion and decision-making on issues for the Medical Devices Program.

The Medical Devices Program ensures, to the extent possible, the safety, effectiveness and quality of medical devices in Canada by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.

There are over 60,000 licensed medical devices on the market today that are governed by the regulations administered under this program.

The three directorates involved in the program are the Therapeutic Products Directorate (TPD), the Marketed Health Products Directorate (MHPD) and the Health Products and Food Branch Inspectorate (HPFBI).

The Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. The Medical Devices Bureau (MDB) is one of 11 offices or bureaux within TPD.

The MDB undertakes the following activities:

• subjects Class III and IV medical devices, whether they are manufactured in Canada or abroad, to a rigorous scientific review of safety and effectiveness data before being authorized for sale in Canada;
• undertakes administrative reviews of Class II devices and reviews safety and effectiveness data of Class I and II devices if issues are identified;
• conducts device testing and research to monitor nature and severity of device problems and laboratory investigations of device-specific incident reports;
• assesses and recognizes third-party auditing organizations, manages the Canadian Medical Devices Conformity Assessment System (CMDCAS), and provides expert advice on quality system requirements;
• develops policy and guidance documents to assist industry in meeting regulatory requirements;
• works with international partners to share information, implement collaborative initiatives and develop international standards;
• works at the international level to harmonize regulatory requirements and to assist countries in developing regulatory systems for medical devices;
• manages requests for access to non-marketed medical devices under the Special Access Program;
• reviews investigational testing/clinical trial applications;
• supports litigation activities pertaining to medical devices in cases involving Health Canada;
• conducts pre- and post-market risk-benefit assessments and makes recommendations on risk management options;
• communicates product related risks to health care professionals and the public in collaboration with MHPD; and
• identifies issues and develops regulatory changes.

The Marketed Health Products Directorate (MHPD) works to assure that HPFB programs take a consistent approach to safety surveillance, assessment of signals and safety trends, and risk communications concerning all regulated marketed health products that are available in the Canadian market. The Marketed Pharmaceuticals and Medical Devices Bureau within MHPD conducts the following activities related to devices:

• monitoring devices incident data;
• reviewing and analysing product safety data;
• detecting and evaluating signals;
• conducting benefit and risk assessments and making recommendations on risk management options;
• communicating product related risks to health care professionals and the public; and
• providing policies to effectively regulate marketed health products.

The Health Products and Food Branch Inspectorate (HPFBI) is responsible for delivery of a national compliance and enforcement program for all products under the mandate of the HPFB (except food), supporting the Branch's risk management approach to decision-making and senior management's vision of a comprehensive regulatory strategy across all product classes. This is accomplished through inspection, compliance verification and investigation, establishment licensing and related laboratory functions. For medical devices the Inspectorate activities include:

• collection, review and follow-up on medical device problem reports;
• compliance verification and investigation of problem reports, recalls and complaints;
• inspections;
• establishment licensing; and
• policy and international activities on HPFBI-related responsibilities.

CHALLENGES AND OPPORTUNITIES

The Industry Environment

Canadians rely on a diverse range of medical devices to diagnose, prevent, or treat a disease, disability, or physical condition. Products such as dialysis equipment, pacemakers, and baby incubators have improved or saved the lives of many. Numerous medical devices such as medical gloves, syringes, X-ray equipment, and surgical lasers are indispensable to today's health care practitioners.

In the medical device industry, scientific disciplines and engineering merge in the creation of innovations that benefit the health care system as well as society at large. Firms in this industry approach the diagnosis and treatment of ailments by providing a wide range of products suited to increasingly specialized needs. There were approximately 500 Canadian medical devices firms which generated over $3.8 billion in sales in Canada and abroad in 2003. Seventy eight percent of the industry's exports went to the United States, where tariffs were eliminated in 1998 under the North American Free Trade Agreement¹. This close trade relationship has likely provided the impetus that has led to calls from Canadian industry for greater harmonization and cooperation internationally, particularly with the United States Food and Drug Administration (U.S. FDA).

A recent study estimates the total number of foreign and domestic medical devices companies operating in Canada at 1,500 employing over 35,000 people, not taking into account medical imaging or assistive devices². About 1,600 companies hold medical device establishment licenses. This includes the 1,500 companies mentioned above, as well as others who import or distribute medical devices, or manufacture Class I devices, such as toothbrushes and bandages. There are approximately 60,000 licensed medical devices currently on the market in Canada, and with this number continuing to grow exponentially, it is increasingly challenging to maintain the level of service Canadians and industry require within the current budget.

Recent advances in technology and health research are contributing to the rapid development of new medical devices. New technologies, such as nanotechnology and the combination of product categories, such as drug-eluting stents, create new regulatory challenges. The program will address these new challenges with regulatory foresight and the development of guidances for industry to ensure Canadians continue to receive safe and timely access to medical devices.

The Regulatory Environment and Program Pressures

The Medical Devices Program continues to evolve to meet the needs and expectations of Canadians to the extent possible under the current structure and level of resourcing. However, a number of issues must now be addressed in order to ensure the program can adapt to the changing environment, deal with increasing number of product submissions, provide adequate risk information to users and health professionals and build the program that will ensure Canada's system remains one of the most respected both in Canada and internationally.

Human Resources - Stringent human resource requirements and practices sometimes make it difficult to attract the staff to the Medical Devices Program with both the required level of scientific and management expertise along with appropriate language skills.

Financial Resources - Currently there is no stable funding that is directed toward activities pertaining to medical devices on a yearly basis.

Procedures - Many staff have identified the need for better ongoing coordination between all areas of the program including an integrated resource allocation and decision-making process.

Structure - The program is currently managed under a matrix structure within the HPFB where decision-making authority is shared among three Directors General. If not managed carefully, this can result in unclear direction and competition among the directorates for staff and funds. There is increased emphasis on fostering a culture of greater inter-directorate collaboration and undertaking a programmatic approach. The establishment of the Directors General Coordinating Committee is a positive step in that direction.

Federal/Provincial/Territorial Issues - Health care issues continue to dominate discussions between the federal government and the provinces and territories. However, medical device issues do not figure prominently on the agenda. As the medical device industry continues to evolve and become more sophisticated, the program must strengthen federal-provincial-territorial cooperation to ensure issues are discussed at all the appropriate levels.

International Relationships - Health Canada continues to be an active participant of the Global Harmonization Task Force (GHTF) in the efforts to create a harmonized regulatory system for medical devices for use by all countries. In addition, as part of Health Canada's International Harmonization efforts, two significant international projects are underway. Firstly, collaboration between Health Canada and the U.S. FDA continues on developing a partnership where both jurisdictions could utilize multi-purpose quality systems audits conducted by one auditor to cover the regulatory requirements of both jurisdictions. Secondly, a Memorandum of Understanding is under development between Health Canada and Australia's Therapeutic Goods Administration (TGA) for the mutual recognition of Quality Management Systems certifications for medial device manufacturers. Although much work is already being done at the international level, staff must continue to foster relationships at all levels through participation at international fora, negotiation and implementation of Memoranda of Understanding and building informal information sharing partnerships.

Transparency - The need to build a better culture of transparency both internally and with external stakeholders is an ongoing priority.

MOVING FORWARD

This time of rapid technological advancement along with increased emphasis on patient safety, transparency, and calls for increased emphasis on the need for appropriately resourced and managed regulatory programs can provide challenges to the program. However, the visibility of these program challenges can also open up tremendous opportunities to reorient program resources, identify new sources of funds and reinvigorate the program to meet the needs of the future - creating a program that is vibrant, relevant and responsive to the needs of Canadians and health professionals.

OUR VISION

Simply stated......The Health Products and Food Branch monitors and evaluates the safety, efficacy and quality of diagnostic and therapeutic medical devices in Canada so that consumers and health care professionals can use them with confidence.

We envision a program that is internationally recognized for the high quality of its benefit-risk decision-making process, its commitment to transparency and the provision of timely information to industry, health professionals and patients and its leadership in acting as a catalyst for greater international cooperation and harmonization.

We envision a program with a clear governance structure that will support management and employees who are driven by excellence and a commitment to providing high quality and reliable service for Canadians.

We envision a program that is a respected employer of choice for the best and the brightest scientific and administrative staff who are supported by high quality, leading edge management systems that enable them to meet targets and exceed the expectations of Canadians.

STRATEGIC OBJECTIVES

Supporting the program vision, a number of strategic objectives have been identified that further elaborate on the vision:

1. Regulatory and Program Modernization - will enable the MDP to manage risk proactively and efficiently and keep pace with the rapidly changing environment within which Health Canada regulates.

2. Human Resources - The Right People to Get the Job Done: Ensure the program is staffed with the appropriate number of qualified people with the knowledge, skill and drive to meet the needs of the users of medical devices in Canada.

3. Stable Adequate Funding - will ensure funds are in place to meet all program requirements, standards, strategic improvements and challenges.

4. Governance and Business Transformation - will result in a flexible and integrated management environment, and allow for clear and effective decisions to be made efficiently and on time. This will ensure the program infrastructure and organizational structure can meet the growing needs of the medical device industry and allow program staff to effectively meet performance targets.

5. Sound Partnerships, Effective Relationships and Open, Transparent Communications - will result in strong strategic partnerships to help fulfill our mandate and Health Canada will be regarded nationally and internationally as a highly respected source of accurate and timely information.

MEETING THE CHALLENGE

In order to achieve the strategic objectives, the program will implement the following activities related to each strategic objective over the course of the next five years (2007 - 2012).

1. Regulatory and Program Modernization

Advances in science, medicine and technology will challenge the way medical devices are regulated. In line with the HPFB Strategic Plan and Blueprint for Renewal, the Medical Devices Program plans to take measures to ensure that regulatory interventions are proportional to risk and to strengthen safety oversight through the adoption of life cycle approaches. Regulatory and Program Modernization will allow the MDP to keep pace with the rapidly changing regulatory and technical environment in which Health Canada works.

The Risk Management Framework provides the basis for all regulatory and health protection work within Health Canada, and in particular the Health Products and Food Branch. It provides the structure for a quality management process that integrates all elements of the program. In support of the framework and the work of the program, and in consultation with relevant stakeholders, the following will be undertaken:

Increase and Strengthen Regulatory Tools and Abilities - Opportunities for harmonized or shared activities with other jurisdictions will continue to be identified, developed and implemented. Best practices and lessons learned from other regulators will be examined and adopted. Health Canada will develop regulations for the reuse of single-use devices. Regulatory tools and abilities to enhance compliance and enforcement powers will be developed and implemented, in particular a ticketing scheme to provide consequences for non-compliance with the Regulations.

Being More Proactive in All Stages of the Life Cycle of a Medical Device, including Early Development Phases - The investigational testing regulations will be amended to increase the risk management of this critical stage in the development of medical devices. This will include the requirement of investigational testing to conform with Good Clinical Practices and the provision that interim and/or final reporting to Health Canada will be required. In addition, an investigational testing inspection strategy and program will be developed.

Strengthen Post-Market Activities, including Surveillance and Monitoring of Safety and Effectiveness - Plans to develop and implement a risk-based approach to product vigilance will allow the MDP to manage risks more proactively. Efforts will be made to implement common practices across the program which, where possible, are consistent with other product lines, e.g., risk communications, health hazard evaluations, signal assessments. A laboratory needs analysis will be conducted to investigate how the program can strengthen its laboratory capabilities and ensure our lab facilities meet the requirements for the program. Some other specific activities include the implementation of an action plan to increase the awareness of the regulatory requirements for medical devices and decrease the number of unlicenced devices on the Canadian market. The issue of counterfeit medical devices will be evaluated as well and a strategy developed in order to address the inherent risks. The HPFBI will increase its capacity to perform inspections to bring the frequency of inspections in line with international standards of practice. A Sentinel System for Canada, designed to increase the quantity and quality of problem reports from a smaller set of representative medical device users/facilities, will be developed and implemented.

2. Human Resources - The Right People to Get the Job Done

The MDP has a number of long-term employees with extensive historical knowledge of the program and invaluable expertise and experience. The program will look for ways to encourage and support knowledge transfer and the use of this expertise to develop talented staff who will be ready to assume greater regulatory and management responsibility as other workers retire or move on to new challenges. Maintaining a dynamic and supportive working environment that will attract new employees and promote a workplace environment of learning and growth will be imperative for the Medical Devices Program of the future. To this end, the program will work on the following:

HR Planning - Utilizing a regularly updated HR plan consisting of short, medium and long-term objectives will identify required resources, skills and experience levels needed to help the program put in place a workforce that can meet the future's growing demands.

Training Plan - With the constant advances in science and technology, staff need access to training to provide them with the knowledge to be able to do their jobs. A robust training plan for all staff, including technical, language and basic training courses will be developed.

Developing a Culture of Cross-Training - Efforts will be made to develop cross-training opportunities for staff to build a broader range of skills for employees and promote a better understanding of the broader picture within the program and within the Branch.

Working Together - As staff are based in three different directorates and across the country, efforts will be made to bring staff together for annual all-staff meetings to share ideas and build better working relationships.

3. Stable Adequate Funding

In order to establish stable and adequate resources to meet all program requirements and performance standards as well as undertake the activities outlined in the strategic objectives, the MDP is engaging in two key Branch activities:

Cost Recovery - The HPFB's Cost Recovery Initiative is developing an up-to-date external charging framework that covers the regulation, licensing and post-market surveillance of health products, including medical devices. The system will be put in place to ensure charging covers all allowable aspects of the program.

Comprehensive Review of Programs and Resources - The unique needs of the program will be captured by the Branch's Comprehensive Review of Programs and Resources whose objective is to ensure adequate funding is available to allow the program to deliver on its mandated activities.

Additionally, the program will identify current gaps in its activities and monitor for emerging issues. An analysis of the funding required to meet the strategic objectives will be undertaken and funding through a Memorandum to Cabinet and Treasury Board submissions will be sought to finance activities not captured by cost recovery or A-Base initiatives.

4. Governance and Business Transformation

Governance and business transformation will result in a flexible and integrated management environment where clear and effective decisions are made efficiently and the program is able to consistently maintain or exceed performance standards. The current elements of the program which are managed under three separate directorates will be examined to ensure that the structure and supporting administrative processes are adequate and appropriate to suit the growing number of medical devices and allow staff to meet performance targets. More specifically, work will be undertaken as follows:

Managing Better Within the Current Structure - The program will look at management options that could allow for more effective means of working under the current matrix management system in the Health Products and Food Branch. A permanent program secretariat has been established and regular program management meetings involving all three Directors General, managers and staff are held to discuss issues for the Medical Devices Program. Additionally, options for shared approaches to program representation at the Branch level and a horizontal approach to funding requests that reflect the unique needs of the program within the Branch structure will be explored.

Existing processes will be reviewed and revised to remove any unnecessary steps or activities that are not value added and increase the time to decision. Efforts to integrate planning across program elements will be made. Communicating key strategic direction for the program will be improved and shared at annual program all-staff meetings.

Review of Structural Options for the Longer Term - The program will review alternative governance and organizational structures that could be implemented over the longer term. This review would be undertaken in conjunction with any similar Branch wide initiatives and will examine how medical devices issues can be best represented at the Branch in order to have equality with other product lines. The program must ensure that the structure and organization suits the needs of the growing industry and allows staff to meet performance targets. By improving processes and assigning the appropriate levels of delegation of authority will result in improved timeliness and efficient decision making within the program. In particular, a system to better track the issuance of establishment licences in order to meet service standards will be developed.

An integrated Performance Measurement Framework (PMF) covering all aspects of the Medical Devices Program will be developed. This will allow for effective performance reporting of activities currently being conducted and highlight areas requiring improvements. The PMF will help build a business case for the MDP by outlining current and anticipated activities related to the functioning of the program and maintenance of performance sustainability.

5. Sound Partnerships, Effective Relationships and Open, Transparent Communications

Many different organizations and individuals contribute to health care in Canada including Health Canada, provincial and territorial governments, health care providers, manufacturers and consumers. Consumers have a responsibility to make informed choices about their health. Because health care services and products are delivered through the provincial and territorial programs, health care management initiatives must be carefully integrated across and between jurisdictions.

Working in partnership with stakeholders, international regulatory authorities and other departments and levels of government has always been an integral part of the work of MDP staff. The following activities will be undertaken to supplement these ongoing relationships and activities:

A Focussed Approach to International Cooperation - A strategic plan for international work will be implemented and regularly revised. It will capture the current efforts being made with the Global Harmonization Task Force (GHTF), the FDA and the TGA, and take a realistic work-sharing strategy approach with international partners. Health Canada will be a major force in the efforts to create a harmonized regulatory system for medical devices for use by all countries and assist in the development of regulatory systems for medical devices in those countries looking to develop them. Health Canada will continue to contribute its expertise to the development of international and national standards.

Strong and Positive Partnerships with Stakeholders - are required to achieve the program's mandate. Work will be undertaken with stakeholders and end-users to develop and implement joint activities to increase the reach and effectiveness of communication products, in particular develop and utilize partnerships with interested organizations and associations. Partnership with the Canadian Border Services Agency will continue as the program looks for ways to address border control issues to reduce the number of non-compliant medical devices entering Canada. Program managers will engage stakeholders and provincial regulatory authorities in a discussion of how best to improve end-user training, including the possibility of a requirement for the manufacturer to provide training on certain high-risk devices. A commitment on the part of the Branch is to strengthen federal-provincial-territorial interaction and cooperation. Other relationships and partnerships will continue to be established.

Improve Communications with Stakeholders - in order to be regarded as a nationally and internationally highly respected source of accurate and timely information. Program managers will work with communications and public involvement staff to identify means of improving timeliness of communications. With the aim to increase the openness and transparency of the development and safety of medical devices several initiatives are being examined. One initiative is the registration and disclosure of clinical trial information for health products regulated by Health Canada, including medical devices. The HPFBI is working on the development of an electronic transparency and accountability compliance kit (E-Tack), a web-based tool to facilitate the posting of compliance and enforcement actions on a publicly accessible website as well as the posting of information on problem reports. The recommendations of an Expert Advisory Committee on how Health Canada can improve communications with stakeholders will be utilized. A stakeholder relations framework is being developed to assist with identifying mechanisms to improve communications with stakeholders.

MEASURING SUCCESS

The Medical Devices Program is developing a detailed Performance Measurement Framework (PMF) for the program. This PMF will include performance measurement, monitoring, evaluation and reporting strategies that will allow managers to track progress against objectives set out in Building for the Future and ensure that work remains on course in support of the vision.

Performance measures and timelines for data collection have been identified for all regular program activities (e.g., number of applications to be reviewed, number of stakeholder complaints, etc.). Data will be collected at regular intervals by identified responsibility centres. This data will be compared to outcome indicators to measure successes and identify areas for improvement.

By putting in place a formal performance evaluation process, the Medical Devices Program will be able to benefit from an ongoing process of learning and improvement.