Country guide: Canada
Cleanroom contractor in Canada: rules for buyers
In Canada Health Canada licenses the owner's drug establishment, not the contractor. Health Canada has been a PIC/S participating authority since January 1999, and Canada applies surtaxes to some steel and aluminium goods from China.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your plant
Health Canada says all Canadian drug establishments must hold an establishment licence, since 1 January 1998, to fabricate, package, label, distribute, import, wholesale or test a drug. The page points to the GMP Inspection Policy for Canadian Drug Establishments (POL-0011) and to guidance on evidence of compliance for foreign sites (GUI-0080). Its details date is 29 May 2025 (Health Canada, establishment licences).
| Activity | Rule |
|---|---|
| Fabricate, package, label, test | Drug establishment licence |
| Import, wholesale, distribute | Same licence |
| GMP inspection | Policy POL-0011 |
Who builds cleanrooms here
Licence holders that fabricate, package, label or test drugs are the regulated buyers, because each of those activities needs the licence. Provincial building codes, professional engineering rules and hospital standards differ by province, and this page does not cover them. Ask the owner which province's rules and which engineer of record apply.
What a foreign supplier must arrange
Finance Canada lists two surtaxes that can reach goods from China. A 25 percent surtax on certain steel and aluminium products from China took effect on 22 October 2024. A separate 25 percent surtax took effect on 31 July 2025 on certain steel or aluminium goods that contain steel melted and poured in China or aluminium smelted and cast in China. Goods with a cumulative value for duty of 5,000 dollars or less are exempt from the second surtax (Finance Canada, page dated 24 September 2026).
Both surtaxes apply to listed products, so the owner's customs broker must check each tariff line for panels, doors and framing. This page does not claim any given product is inside or outside the lists.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State the province, whether the plant is new or existing, and whether the rooms are sterile. Say whether the owner has a drug establishment licence or is applying for one.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does Health Canada approve cleanroom contractors?
No. It licenses the owner's drug establishment. The owner chooses and manages the contractor.
Since when is an establishment licence required?
Since 1 January 1998 for Canadian drug establishments, according to Health Canada.
Does the Chinese steel surtax cover every panel?
It covers listed products only. Check each tariff line (Finance Canada, page dated 24 September 2026).
Is Canada a PIC/S member?
Yes. PIC/S lists Health Canada with accession to the scheme in January 1999 (PIC/S, checked 1 November 2026).
Related guides
- How to Import a Cleanroom from China
- How to choose a cleanroom contractor: questions and evidence
- How to audit a cleanroom panel factory, on site or by video
- Building a cleanroom inside an existing building
- Turnkey cleanroom contractor
- Room list builder
Sources
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184