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Medical Devices Regulations

Version of section 11 from 2016-07-17 to 2024-10-14:

  •  (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

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