Guide for recalling medical devices (GUI-0054): Glossary

The following definitions explain how terms are used in this guidance document. If there's a conflict with a definition in the Food and Drugs Act or associated regulations, including the Medical Devices Regulations (regulations), the definition in the act or regulations prevails.

Where applicable, we have provided the source of the definition, including from the following International Organization for Standardization (ISO) standards:

• ISO 13485 - Medical devices quality management systems: System requirements for regulatory purposes
• ISO 14971 - Medical devices: Application of risk management to medical devices

Consignee:

Anyone who received purchased or used a product being recalled.

Control number:

A unique series of letters, numbers or symbols, or any combination of these, that's assigned to a medical device by the manufacturer and from which a history of the manufacture, packaging, labelling and distribution of a lot or batch of the device can be determined.

Correction:

Action to eliminate a detected non-conformity. This can include a recall to address non-conforming devices in distribution. Includes the repair, modification, adjustment, re-labelling or inspection (including patient monitoring) of a device without its physical removal to some other location.
A correction can be made in conjunction with a corrective action (for example, a rework or regrade). (ISO 13485)

Device identifier:

A unique series of letters or numbers or a bar code that the manufacturer assigns to a medical device to identify and distinguish it from similar devices.

Distributor:

A person other than a manufacturer, importer or retailer who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.

Effectiveness check:

Includes a survey of those affected by the recall (consignees) to verify they have received the recall notification and are aware of any appropriate action to be taken. May include verification of the action taken. The recalling firm is responsible for conducting effectiveness checks, which may also be undertaken or verified by Health Canada.

Establishment:

A person required to have an establishment licence as per section 44 of the regulations.
Learn more about licensing requirements:

• Guidance on medical device establishment licensing and medical device establishment licensing fees (GUI-0016)

Harm:

Injury or damage to the health of people, or damage to property or the environment. (ISO 14971)

Hazard:

Potential source of harm. (ISO 14971)

Health hazard classification:

The numerical designation (for example, Type I, II or III) assigned to a recall of a device to indicate the degree of risk presented by the recall, with Type I being of the highest concern.

Health risk assessment:

The scientific characterization of the probability of occurrence and severity of known or potential adverse health effects resulting from exposure to hazards. The process includes hazard identification, hazard characterization, exposure assessment and risk characterization.

Implant:

A medical device listed in Schedule 2 of the regulations.

Importer:

A person in Canada, other than the manufacturer of a device, who is responsible for the medical device coming into Canada for sale.

Label:

Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. Labels are information affixed to a device or the packaging as well as to manuals, package inserts, brochures and leaflets. (Section 2, Food and Drugs Act)

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
• 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:

A device within the meaning of the act except any device that's intended for use in relation to animals. Includes used devices, parts and accessories.

Medical device identification number (device ID):

The number that Health Canada gives to a device in order to enter the information about the device into the medical devices database. The device ID was formerly known as the "device accession number". It is not the same as the device "identifier" that's assigned by the manufacturer.

Person:

Includes a partnership and an association.

Quarantine:

Effective restriction of the availability of material or device for use or distribution by the company, until released by a designated authority.

Recall depth:

The level of distribution from which a device is recalled (for example, wholesale, retail, user or consumer).

Recall strategy:

A planned course of action taken by a recalling company in conducting a specific recall. Examples include the depth of recall, the need for public warnings and the extent of effectiveness checks for the recall.

Risk:

The probability that harm will occur combined with the severity of that harm. (ISO 14971)

Risk analysis:

Systematic use of available information to identify hazards and estimate the risk. (ISO 14971)

Risk assessment:

Overall process comprising a risk analysis and a risk evaluation. (ISO 14971)

Risk evaluation:

Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.. (ISO 14971)

Significant change:

A change that could reasonably be expected to affect a medical device's safety or effectiveness. Includes a change to the:

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

Stock recovery:

A manufacturer, importer or distributor's removal or correction of a device that has not been distributed or has not left the direct control of the company.
A stock recovery is not considered a recall. However, if product leaves the control of a manufacturer but has not left the control of subsequent importers or distributors, the action is considered a recall at the manufacturer's level and a stock recovery at the importer/distributor's level.
If permitted by the manufacturer (as per section 65.1 of the regulations), the importer may prepare and submit recall information and documents on the manufacturer's behalf.