Medical Devices Directorate

The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use.

Before authorizing the sale of a medical device in Canada, we verify that the device meets the safety, effectiveness and quality requirements of the Food and Drugs Act and its Regulations.

We also work collaboratively with other organizations to assess medical device risks and to make regulatory decisions to manage those risks.

Once we have assessed them, we communicate openly and transparently about those risks to help Canadians make informed decisions.

On this page

• What we do
• Offices and bureaus
• For more information
• Contact us

What we do

The Medical Devices Directorate (MDD) is responsible for:

• reviewing scientific information to assess the safety, effectiveness and quality of medical devices
• assessing the potential benefits and risks of a medical device
• reviewing applications for Investigational Testing Authorizations (ITAs) for medical devices to ensure that:
  • studies are well designed
  • participants will not be exposed to undue risk
• monitoring the evolving safety of medical devices in development and already on the market, through review of adverse reaction reports submitted as a requirement of the Medical Devices Regulations 
• making unlicensed medical devices available to health care professionals for patients when conventional therapies have failed, aren't suitable or are not available
• providing Canadians with the science-based medical information they need to make informed choices

Offices and bureaus

The Directorate consists of 6 offices and bureaus:

• Director General’s Office
• Bureau of Licensing Services
• Bureau of Investigation Testing Authorization, Special Access Program and Post-Market Surveillance
• Bureau of Evaluation
• Bureau of Planning and Operations
• Bureau of Policy and International Programs

Director General's Office

The Director General's Office authorizes the sale of higher risk medical devices, makes regulatory decisions and oversees investigational testing. The Office also:

• communicates with stakeholders in Canada and around the world
• manages the Directorate's work and reports to senior officials in the Department
• oversees and directs projects that manage the strategic vision, focus and priorities of the Directorate and aligns them to those of the Branch, Department and Federal Government

Bureau of Licensing Services

This Bureau is responsible for:

• authorizing the sale of lower risk Class II medical devices
• providing project management services and logistical support related to medical device licence applications
• managing stakeholder enquiries regarding medical device classification

Bureau of Investigational Testing Authorization, Special Access Program and Post-Market surveillance

This Bureau is responsible for:

• reviewing applications for the sale of medical devices for use in investigational testing
• evaluating clinical and scientific safety data of marketed medical devices to determine their safety profiles, which includes:
  • conducting safety assessments and benefit-risk assessments and
  • reviewing adverse event reports and Risk Management Plans
• providing expedited access to unlicensed medical devices under the Special Access Programme, in emergency situations or when conventional therapies have failed, are unavailable or are unsuitable

Bureau of Evaluation

This Bureau is responsible for reviewing applications for new and amended medical device licences for:

• digital health devices (for example, diagnostic imaging devices, therapeutic lasers, software devices)
• in vitro diagnostic devices (for example, HIV test kits and blood glucose meters)
• cardiovascular devices (for example, pace makers and heart valves)
• musculoskeletal devices (for example, orthopaedic and dental implants)
• general and restorative devices (for example, ophthalmic devices and ventilators)

Bureau of Operations and Planning

This Bureau provides corporate support for the Directorate, including development of:

• training
• standard operating procedures
• documents supporting pre-market transparency

In addition, this Bureau is responsible for:

• holding regular meetings with stakeholders
• administering an internal quality management system
• managing the Medical Device Single Audit Program
• providing strategic integrated planning, performance measurement and business intelligence
• managing finances and operations in the Directorate

Bureau of Policy and International Programs

This Bureau is responsible for:

• providing support on international files related to medical devices
• developing and implementing guidance documents and policies
• developing, maintaining and implementing policy to support the Directorate's work
• supporting the engagement of external experts through Scientific Advisory Committees and Panels

For more information

• Drugs and Health Products
• The Drug and Health Product Register
• Medical Devices Active Licence Listing (MDALL)

Contact us

Medical Devices Directorate
Health Products and Food Branch
11 Holland Avenue, Tower A
2nd Floor
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

General Enquiries

E-mail: meddevices-instrumentsmed@hc-sc.gc.ca
Telephone: 613-957-7285
Teletypewriter: 1-800-465-7735 (Service Canada)