About donor sperm and ova inspections

The Safety of Sperm and Ova Regulations focus on reducing the potential health risks to individuals in Canada who use donor sperm or ova (eggs) for the purpose of assisted human reproduction (AHR) to build their families.  This includes the risk of infectious and genetic disease transmission. Health Canada conducts inspections of establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of AHR. 

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Donor sperm and ova

Donor sperm and ova (eggs) are sperm and ova that are intended for use in assisted human reproduction (AHR) by a recipient who is not the spouse, common-law partner or sexual partner of the donor.

This includes:

In Canada, establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of AHR must comply with the:

The AHR Act and the Safety Regulations allow Health Canada inspectors to:

 Processing donor sperm and ova includes:

What inspectors look for

During inspections, inspectors:

After an inspection

After completing an inspection, the inspector creates an Exit Notice report that:

The overall rating indicates whether the establishment or health professional is compliant or non-compliant with the:

The rating is based on:

Compliant rating

A compliant rating means the establishment or health professional is complying with the AHR Act and the Safety Regulations.

An establishment or health professional may receive a compliant rating even if a number of observations have been identified. This is because the rating also takes into consideration the level of risk.

The establishment or health professional will need to take corrective actions to address any observations.

Non-compliant rating

A non-compliant rating means that the establishment:

In the case of a non-compliant rating, we will consider specific enforcement actions (e.g. recalls, public advisories, suspension or cancellation of a registration) in accordance with the Compliance and Enforcement Policy for Assisted Human Reproduction Act POL-0100.

Ongoing follow-up

Establishments and health professionals must take corrective actions to address the observations either during the inspection or after it. They must provide Health Canada with a written corrective action plan for any observations identified, including target dates for completion.

A follow-up inspection may be conducted to make sure the corrective actions have been taken.

Inspection report cards

Health Canada posts detailed report cards for inspections. Each report card summarizes the inspection observations and ratings:

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