Canada proposed regulations entitled Safety of Sperm and Ova Regulations Department of Health proposed Safety of Sperm and Ova Regulationswould establish a human health and safety framework for donor sperm and ova for assisted human reproduction. Specifically, the proposed regulations would: - Establish minimum requirements for screening and testing sperm and ova donors;
- Establish a risk-based registration and notification oversight scheme for establishments who process, import and distribute donor sperm and ova;
- Establish a traceability system whereby donor sperm and ova are identified, labelled and stored so that appropriate steps may be taken in the event of an error, accident or adverse reaction; and
Establish a quality management system to ensure that establishments who conduct their activities do so in a manner that prevents contamination or cross-contamination, prevents the transmission of an infectious disease and maintains the quality of the sperm and ova. Products covered: Sperm and ova for assisted human reproduction HS code: 300290 Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: 10-01-2019 |