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.
On this page
- Donor sperm and ova
- What inspectors look for
- After an inspection
- Inspection report cards
- For more information
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.
- donor sperm used in AHR techniques (e.g., in vitro fertilization)
- ova (eggs) obtained from a donor and intended for the same donor's use as a surrogate mother (via in vitro fertilization)
- donor sperm distributed by an establishment or health professional to a recipient for their personal use
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:
- Assisted Human Reproduction Act (AHR Act)
- Safety of Sperm and Ova Regulations (Safety Regulations)
The AHR Act and the Safety Regulations allow Health Canada inspectors to:
- assess whether establishments and health professionals are complying with all of the applicable regulatory requirements.
- monitor establishments and health professionals that process, import, distribute or make use of donor sperm and ova for use in AHR.
Processing donor sperm and ova includes:
- performing the donor suitability assessment
- obtaining the sperm or ova from a donor
- assessing quality
- quarantining, or
What inspectors look for
During inspections, inspectors:
- review records, procedures and documents.
- assess compliance with the applicable requirements such as
- donor testing and screening
- donor suitability assessments
- quality management principles
- error and accident investigations and reporting
- adverse reaction investigations and reporting
- make observations when they note areas where the establishment or health professional is not meeting regulatory requirements. Each observation is classified by level of risk. Higher risk observations require immediate or expedited corrective actions.
After an inspection
After completing an inspection, the inspector creates an Exit Notice report that:
- documents the findings
- outlines the observations
- issues an overall inspection rating
The overall rating indicates whether the establishment or health professional is compliant or non-compliant with the:
- AHR Act
- Safety Regulations
The rating is based on:
- the number of observations noted by the inspector
- risk level of each observation
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.
A non-compliant rating means that the establishment:
- has not shown that its activities comply with the AHR Act and the Safety Regulations;
- needs to take immediate corrective actions if higher risk observations were noted that could lead to immediate or potentially serious health risks to Canadians.
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.
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:
For more information
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