Mandatory reporting requirements for hospitals

Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.

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Regulatory requirements for hospitals

Hospitals are required to report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs), according to the following regulatory requirements:

Which hospitals must report

The mandatory reporting regulatory requirements apply to hospitals that are:

Why and what to report

Why report

Canada's monitoring of therapeutic products plays an important role in public health and patient safety.

Hospitals help make health products safer by reporting serious adverse drug reactions and medical device incidents. Reports of serious ADRs and MDIs:

What to report

The mandatory reporting requirements for hospitals apply to the following therapeutic products:

Hospitals are not required to report on:

When in doubt, Health Canada encourages hospitals to report.

When and how to submit reports

Mandatory reporting by hospitals must be submitted in writing within 30 days of the serious ADR or MDI being documented. We encourage hospitals to report sooner if possible.

For information on how to report a serious ADR or MDI, please see Report an adverse reaction or medical device problem.

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