Guidance on medical device compliance and enforcement (GUI-0073): Glossary
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Acronyms and abbreviations
- MDR
- Medical Devices Regulations
- MDEL
- medical device establishment licence
- MDCV
- medical device compliance verification
- UPHN
- urgent public health need
Terms
Some definitions are from particular sections of the Food and Drugs Act (act) or Medical Devices Regulations (MDR).
- Advertisement
- Any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. (section 2, act)
- Authorization
- Unless the context requires otherwise, an authorization that is issued for medical devices for an urgent public health need. (section 68.12, MDR)
- Compliance
- The state of conformity of a regulated party, product or activity with legislative, regulatory and authorization requirements.
- 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 a distributor.
- Enforcement activities
- Actions taken to compel compliance of a regulated party, product or activity with legislative, regulatory and authorization requirements.
- Importer
- A person in Canada, other than the manufacturer of a device, who is responsible for the medical device coming into Canada for sale.
- List of Medical Devices for an Urgent Public Health Need
- The List of Medical Devices for an Urgent Public Health Need is published by the Government of Canada and is amended from time to time.
- 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
(section 1, MDR)
- Non-compliance
- A non-fulfillment of a legislative, regulatory or authorization requirement.
- Recall
Under section 21.3 of the act, is:
- (a) a recall ordered by the Minister or
- (b) any action taken by the manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:
- (i) may present a risk of injury to health
- (ii) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety or
- (iii) may not meet the requirements of the act or MDR
- Regulated party
Any party that is working with medical devices and subject to the act and the MDR, for example:
- manufacturers
- importers
- distributors
- suppliers
- individuals
- aesthetic-related clinics and spas
- partnerships
- associations
- UPHN medical device
Any of the following medical devices for an urgent public health need:
- a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1
- a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1