Guidance on how to complete the application for a new medical device licence: Definitions

Bisphenol A [BPA; Phenol, 4,4' -(1-methylethylidene)bis-]: An industrial raw material that was identified for screening assessment under the Canadian Environmental Protection Act. BPA is mainly used as a raw material in the production of polycarbonates and epoxy resins. BPA or BPA-based polymers are used in the manufacture of a variety of medical devices, including resin-based dental composite restorative and prosthodontic materials, dental sealants, hemodialyzers, hemofilters and blood oxygenators.

Please refer to Appendix 1, Table 1 for the chemical identity of BPA, including its Chemical Abstracts Services (CAS) registry number and synonyms.

Device ID: Refers to the device identification number assigned by Health Canada.

DI(2-Ethylhexyl) Phthalate (DEHP): A chemical additive that is used to make polyvinyl chloride (PVC) soft, flexible and kink-resistant. PVC plasticized with DEHP is currently used in a variety of medical devices, including blood bags, catheters, intravenous tubing and medical gloves.

A medical device is considered to contain DEHP if the amount of DEHP in the device is more than or equal to 0.1% of the device's mass (that is, ≥0.1% w/w).

Please see Appendix 2, Table 2 for the chemical identity of DEHP, including its Chemical Abstracts Services (CAS) registry number, synonyms and known trade names.

Medical device: A device within the meaning of the Act, but does not include any device that is intended for use in relation to animals.

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. Examples of an identifier for a device are a catalogue, model or part number.

Licence application type: The application may be submitted as a single device, system, test kit, device group, device family or device group family. The term "test kit" applies only to in vitro diagnostic devices. For more information on licence application types, see the guidance for interpreting sections 28 to 31: licence application type.

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
• is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose

These tasks may be performed by that person or on their behalf. "Person" includes a partnership, firm or association.

Near patient in vitro diagnostic device (IVDD): Is intended for use outside a laboratory, for testing at home or at the point-of-care, such as a pharmacy, a health care professional's office or the bedside.