Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals): SOR/2019-191

Canada Gazette, Part II, Volume 153, Number 13

Registration
SOR/2019-191 June 10, 2019

FOOD AND DRUGS ACT

P.C. 2019-747 June 9, 2019

Whereas, pursuant to subsection 30(1.3) footnote a of the Food and Drugs Act footnote b, the Minister of Health has taken into account existing information management systems with a view to not recommending the making of regulations that would impose unnecessary administrative burdens;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 footnote c of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals).

Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals)

Amendment

1 The Medical Devices Regulations footnote 1 are amended by adding the following after section 61.1:

Provision of Information Under Section 21.8 of Act

62 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a medical device incident.

(2) The following prescribed information about a medical device incident that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the medical device incident is first documented within the hospital:

(3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if

(4) The following definitions apply in this section.

(5) For the purposes of the Act, medical device incident has the same meaning as in subsection (4).

Coming into Force

2 These Regulations come into force on December 16, 2019, but if they are registered after that day, they come into force on the day on which they are registered.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2019-190, The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals).