2 These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use.
(2) Subsection (1) does not apply to a drug listed in Schedule E or F to the Act, in the schedule to Part G or J of the Food and Drug Regulations, in the Schedules to the Controlled Drugs and Substances Act, or in the schedule to the Narcotic Control Regulations.
4 Only sections 26 to 31, 37, 70, 75, 80, 86 and 87 apply to a dispenser.
5 These Regulations do not apply to a medical gas piping system that is assembled on site at a health care facility and permanently built into the structure of the facility.
- SOR/2017-18, s. 22.
Classification of Medical Devices
6 Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.
7 If a medical device can be classified into more than one class, the class representing the higher risk applies.
8 This Part applies to medical devices that are not subject to Part 2 or 3.
(2) A manufacturer shall keep objective evidence to establish that the medical device meets those requirements.
- SOR/2015-193, s. 7.
Safety and Effectiveness Requirements
10 A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to
(a) identify the risks inherent in the device;
(b) if the risks can be eliminated, eliminate them;
(c) if the risks cannot be eliminated,
(d) minimize the hazard from potential failures during the projected useful life of the device.
11 (1) A medical device other than a decorative contact lens shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.
(2) A decorative contact lens shall not adversely affect the health or safety of a user, except to the extent that a possible adverse effect of the device constitutes a risk that is compatible with a high level of protection of health and safety.
- SOR/2015-193, s. 2.
12 (1) A medical device other than a decorative contact lens shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.
(2) A decorative contact lens shall perform as intended by the manufacturer.
- SOR/2015-193, s. 2.
13 During the projected useful life of a medical device, its characteristics and performance shall not deteriorate under normal use to such a degree that the health or safety of a patient, user or other person is adversely affected.
14 The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage, taking into account the manufacturer’s instructions and information for transport and storage.
15 Reasonable measures shall be taken to ensure that every material used in the manufacture of a medical device shall be compatible with every other material with which it interacts and with material that may come into contact with it in normal use, and shall not pose any undue risk to a patient, user or other person.
16 The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including
(a) flammability or explosion;
(b) presence of a contaminant or chemical or microbial residue;
(d) electrical, mechanical or thermal hazards; and
(e) fluid leaking from or entering into the device.
17 A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated.
18 A medical device that is part of a system shall be compatible with every other component or part of the system with which it interacts and shall not adversely affect the performance of that system.
19 A medical device that performs a measuring function shall be designed to perform that function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is manufactured, sold or represented.
20 If a medical device consists of or contains software, the software shall be designed to perform as intended by the manufacturer, and the performance of the software shall be validated.
(a) the name of the device;
(b) the name and address of the manufacturer;
(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d) in the case of a Class III or IV device, the control number;
(e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
(f) the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;
(g) the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;
(h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use;
(i) the directions for use, unless directions are not required
(j) any special storage conditions applicable to the device.
(2) The information required pursuant to subsection (1) shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.
- SOR/2002-190, s. 2;
- SOR/2015-193, s. 3.
(2) Where a package that contains a medical device is too small to display all the information in accordance with section 21, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sale.
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