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.

• 3. (1) These Regulations also apply to an in vitro diagnostic product that is a drug or that contains a drug, as if the product were an in vitro diagnostic device.

• (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, if

• (a) the system meets the requirements of National Standard of Canada CAN/CSA-Z305.1, Nonflammable Medical Gas Piping Systems, as amended from time to time; and

• (b) a certificate of compliance with that standard has been issued by a testing agency that meets the requirements of National Standard of Canada CAN/CSA-Z305.4, Qualification Requirements for Agencies Testing Nonflammable Medical Gas Piping Systems, as amended from time to time.

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.

• 9. (1) A manufacturer shall ensure that the medical device meets the safety and effectiveness requirements.

• (2) A manufacturer shall keep objective evidence to establish that the medical device meets those 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,

  • (i) reduce the risks to the extent possible,

  • (ii) provide for protection appropriate to those risks, including the provision of alarms, and

  • (iii) provide, with the device, information relative to the risks that remain; and

• (d) minimize the hazard from potential failures during the projected useful life of the device.