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• (3) An application for a Class III medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

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  • (f) a summary of all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, and the conclusions drawn from those studies by the manufacturer;

• (4) An application for a Class IV medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

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  • (i) detailed information on all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, including

    • (i) pre-clinical and clinical studies,

    • (ii) process validation studies,

    • (iii) if appropriate, software validation studies, and

    • (iv) literature studies;

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  • (l) a summary of the studies referred to in paragraph (i) and the conclusions drawn from those studies by the manufacturer;

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• 43.12 (1) Information in respect of a clinical study or investigational testing that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the application:

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• (2) Subsection (1) does not apply to information in respect of a clinical study or investigational testing that

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43.11 In sections 43.12 and 43.13, information in respect of a clinical study or investigational testing means information in respect of a clinical study, or investigational testing, involving human subjects that is contained in an application for a Class III or IV medical device licence made under section 32 or in an application to amend such a licence made under section 34.

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Disclosure of Information in Respect of Clinical Studies or Investigational Testing