Canada 

Medical Device Regulations

Bethlehem Molla --------------------ATR/0058/09

Bethelehem Tamrat -------------------ATR/3284/09
Lidya Esayas--------------------------ATR/1640/09
Tsedalemariam Adugna --------------ATR/0811/09

ADDIS ABABA INSTITUTE OF TECHNOLOGY

Center of Biomedical Engineering
 Introduction
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 The four main stakeholders in medical devices are public, health

care professionals, manufacturer (distributers) ,and federal
government.
 Health care professionals play a critical role in relation to
medical devices. To provide the public with information on the
risks and benefits of a device and to learn how to use or install a
device, the health care professional must rely on the
manufacturer.
 And much like the public, health care professionals rely on
government to help ensure the safety and therapeutic
effectiveness of products.
 Regulatory Body
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 All medical devices are regulated by Health Canada, Health

Products and Food Branch, Therapeutic Products Directorate,and
Medical Devices Bureau(MDB).
 Health Canada is a federal department responsible for the
national public health of Canadians. It is responsible for
delivering programs to protect the health and safety of Canadians
in relation to all therapeutic products, including medical devices.
 The approval, sale, marketing, safety, and quality of medical
devices in Canada is regulated by The Medical Devices Bureau
of the Therapeutic Products Directorate (TPD).
 Cont.…
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 Medical Devices Bureau(MDB) is responsible for processing

device license applications upon the review of safety and
effectiveness data and establishing standards and policies for
medical devices as well as addressing related issues regarding the
safety of medical devices.
 Organizational Structure – Bureau
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Medical Devices
Bureau

Director’s office

Device Licensing Associate Device Evaluation

Services Division Director Division
 Cont.
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 The goal of the Medical Devices Program is to ensure that

medical devices available in Canada are safe, effective, and of
high quality.
 This is done through a regulatory framework, whereby the level
of effort given to a device is dependent upon the risk class of the
device and whereby the safety and effectiveness of medical
devices are assessed through a balance of quality- systems
requirements, pre-market activities, and post-market activities.
 Classification of medical devices
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 In Canada, Medical devices are classified into Class I, II, III, and
IV based on the level of invasiveness. Class I represents the
lowest risk and Class IV the highest.

 The European Union has four classes of medical devices which

generally correspond to Canada’s four classes.
Cont.
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 Guidance documents 9

Guidance documents are meant to provide assistance

to industry and health care professionals on how to
comply with governing statutes and regulations.

Guidance for Implementation

The manufacturer should first determine that their
product meets the definition of a medical device as
defined in the Regulations. Once confirmed, the
classification rules should be applied to determine its
proper risk classification.
 Cont.
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 The first step in determining the risk classification of a device is

to review Special Rules 13 to 16.
 If the device in question is not described by one of these Special
Rules, then the manufacturer should determine whether the
device is invasive, non-invasive, or active.
 There will be situations where a device is both non-invasive and
active, or invasive and active, and it is not unusual for more than
one rule to apply to any given device.
 In these situations, the final classification will be determined by
the rule which assigns the higher risk.
 Structure guidance
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 Pre-Market: the Medical Devices Regulations require that all

class II, III, and IV medical devices be licensed for sale by
Health Canada. Factors considered in classifying risk include

 how long the product is expected to be inside the patient (for

example, one hour or 10 years).
 how invasive the product is into the body (for example, inserted
temporarily or implanted fully). and
 How the device interacts with the patient (for example, a device
that does not interact or one that delivers energy to the patient).
 Cont.
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 Post-Market: Inspection activities involve visiting manufacturers,

importers, and distributors to inspect their operations in order to verify
that they are complying with the Food and Drugs Act and the Medical
Devices Regulations.
 For example, Health Canada may inspect the distribution records of a
manufacturer, importer, or distributor to ensure that the records respect
the Regulations. It may also review the action taken by a manufacturer,
importer, or distributor in response to an adverse event to ensure that
the action taken respects the Regulations. Because the Medical Devices
Regulations place significant responsibility for protecting the health of
Canadians on the industry itself, it is particularly important that Health
Canada assess their activities.
13
 Conclusion
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 In general, The Food and Drug Act is law that outlines what you
cannot do, while Medical Devices and Regulations is regulation
that outlines what you must do and Guidance Documents and
Policies are policies that outline how you must do it.
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Thank you