Guidance for determining medical device application type: Definitions

Most of the definitions in this guidance document are taken from the Medical Devices Regulations (regulations). To align with international standards, this guidance document also adopts many terms defined in the Principles of Labelling for Medical Devices and IVD Medical Devices (International Medical Devices Regulators Forum).

Authorization:

An authorization that is issued under section 68.12.

Device ID:

The device identification number assigned by Health Canada. This identification number appears on the issued licence or authorization.

Note: A single device ID may encompass several device identifiers.

Identifier:

A unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices.

Note: Examples of an identifier for a device are a catalogue, model, part number or software version.

Indications for use:

A general description of the disease or condition the medical device or IVD medical device will diagnose, treat, prevent, cure or mitigate. Includes a description of the patient population for which the medical device or IVD medical device is intended. (IMDRF GRRP WG/N52 FINAL:2019)

Note: The indications for use are generally labelled as such. They may also be inferred from other parts of the labelling, including the directions for use, precautions, warnings and bibliography sections.

Intended use/intended purpose:

The objective intent regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. (IMDRF GRRP WG/N52 FINAL:2019)

Note: The intended use and intended purpose are also part of promotional or sales materials or statements, although these materials lie outside the scope of this document. The intended use can include the indications for use.

Manufacturer:

A person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Medical device family:

A group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use.

Medical device group:

A medical device comprising a collection of medical devices, such as a procedure pack or tray that is sold under a single name.

Medical device group family:

A collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group.

Off-the-shelf component or accessory:

A product that is not specifically manufactured and/or designed to suit a particular medical device.

Note: Examples include commercial batteries and generic power cables.

Procedure kit (for instance, procedure pack, surgical tray):

A collection of medical devices, that may or may not be made by the same manufacturer, such as surgical instruments, dressings or materials, that are packaged together for use in a range of surgical procedures in a particular clinical specialty.

Significant change:

A change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following:

• the manufacturing process, facility or equipment
• the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture
• the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories
• the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device, and any change to the period used to establish its expiry date

Single medical device:

A single device that is identified with a unique name by its manufacturer.

System:

A medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device's intended functions, and that is sold under a single name.

Test kit:

An in vitro diagnostic device that consists of reagents or articles, or any combination of these, and is intended to be used to conduct a specific test.