Open ProvincesProcessing, importing or distributing human cells, tissues or organs: register the establishment with Health Canada
Processing, importing or distributing human cells, tissues or organs: register the establishment with Health Canada
Registration covers specific establishments and activities. Clinical accreditation or a partner’s registration does not automatically cover your organization.
Confirm the scope
Determine whether the products and activities fall under the CTO regulations and identify the source establishment, importer, distributor and contractors.
Prepare the information
Document donor screening, traceability, quality, quarantine, storage, recalls, errors, accidents and emergency contacts.
Complete the process
Complete FRM-0171 with every address, activity, CTO type, responsible person and attestation, then submit as directed.
Keep follow-up records
Await the registration number, verify the public list and promptly report changes, cessation, errors or adverse reactions.
CTO establishment registration form — Health Canada
Sources and limits
Official sources are linked in the guide. Checked August 30, 2026; confirm current rules, forms and deadlines with the responsible authority.
General information based on federal and national rules; provincial rules may differ. Confirm with the official body before acting. Last reviewed : 2026-08-30.