DISTRIBUTOR Means any individual, partnership, corporation, association, or other legal relationship which stands between the manufacturer and the retail seller in purchases, consignments, or contracts for sale of consumer goods.

MANUFACTURER A person who sells the 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 Devices Regulations, P.C. 1998-783 7 May, 1998).

MEDICAL DEVICE FAMILY Means 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. Examples might include: intra vascular catheters, insulin syringes, feeding tubes or vascular access grafts. (Medical Devices Regulations, P.C. 1998-783 7 May, 1998).

MEDICAL DEVICE GROUP Means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. Examples might include: a denture repair kit, a declotting tray, a parenteral administration kit or disposable circumcision tray. (Medical Devices Regulations, P.C. 1998-783 7 May, 1998).

MEDICAL DEVICE GROUP FAMILY Means 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. Examples might include: IV administration sets, dressing trays, contact lens care kits or irrigation trays. (Medical Devices Regulations, P.C. 1998-783 7 May, 1998).

PERSON Includes a partnership, firm or association. (Medical Devices Regulations, P.C. 1998-783 7 May, 1998).

QUALITY SYSTEM Organizational structure, procedures, processes and resources needed to implement quality management. (ISO 8402:1994).

REGISTRAR Organization that assesses and registers the quality system of manufacturers with respect to published quality system standards. Examples of quality system standards include ISO 9001 and ISO 13485.

SINGLE MEDICAL DEVICE A medical device that is identified by a unique device name, is sold as a distinct packaged entity and does not meet the criteria or a medical device group, a medical device family, a medical device group family, a system, or a test kit. It may include accessories and may be offered in a range of package sizes, and is represented by a unique device name. Examples might include: an acupuncture needle, an aneurysm clip, a larynx prosthesis or dental cement.

SYSTEM Means 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 and are manufactured by the same manufacturer. Examples might include hip prostheses, knee prostheses or an ultrasonic imaging system. (Medical Devices Regulations, P.C. 1998-783 7 May, 1998).