Vol. 151, No. 49 — December 9, 2017

Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information).

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information).

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Holland Cross, Tower A, Ground Floor, Suite 14, 11 Holland Avenue, Address Locator: 3000A, Ottawa, Ontario K1A 0K9 (email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, November 30, 2017

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)

Amendment

1 The Medical Devices Regulations (see footnote 1) are amended by adding the following after section 43.1:

Disclosure of Information in Respect of Clinical Studies or Investigational Testing

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.

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:

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

43.13 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical study or investigational testing that has ceased to be confidential business information.

Transitional Provisions

2 (1) Despite section 43.11 of the Medical Devices Regulations, information in respect of a clinical study or investigational testing, as defined in section 43.11 of those Regulations, that is confidential business information and that is contained in an application with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:

(2) Subsection (1) does not apply to information referred to in subsection 43.12(2) of the Medical Devices Regulations.

Coming into Force

3 These Regulations come into force on the day on which they are registered.

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