Country guide: Switzerland
Cleanroom contractor in Switzerland: rules for buyers
In Switzerland Swissmedic licenses the owner's medicine plant, not the contractor. Swissmedic has been a PIC/S participating authority since February 1996, and building products fall under the Swiss Construction Products Act.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your plant
Swissmedic says companies that make medicines or trade in them need an operating licence (Betriebsbewilligung) under articles 5, 18, 28 and 34 of the Therapeutic Products Act (HMG, SR 812.21) and the Medicinal Products Licensing Ordinance (AMBV, SR 812.212.1). Licences go to the legal entity entered in the commercial register, and all holders are listed in the SwissGMDP database (Swissmedic, operating licence holders).
Swissmedic's page does not explain how inspections relate to the licence, so ask the owner's regulatory team how the site inspection will be scheduled.
| Facility | Rule |
|---|---|
| Medicine plant | Swissmedic licence, HMG articles 5 and 18; AMBV |
| Licence holder | Legal entity in the commercial register |
| Public list | SwissGMDP database |
Who builds cleanrooms here
Companies that make medicines are the regulated buyers, because Swissmedic licenses manufacture at each licensed entity. This reading comes from the rules, not from market statistics.
What a foreign supplier must arrange
The Construction Products Act (BauPG, SR 933.0) of 21 March 2014 regulates placing construction products on the Swiss market. It defines an authorised representative as a person established in Switzerland who a manufacturer has mandated in writing to act on its behalf. It also says an importer or distributor that sells a product under its own name or brand takes on the manufacturer's duties (BauPG, checked 1 November 2026).
A panel supplier from outside Switzerland should therefore ask the owner who will act as the Swiss-based party. This page does not assume that EU CE marking alone is enough in Switzerland, so confirm it with the owner's counsel.
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 whether the plant is new or existing, whether the rooms are sterile, and the canton. Name the quality head who will deal with Swissmedic.
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 Swissmedic approve cleanroom contractors?
No. Swissmedic licenses the owner's company. The owner chooses and manages the contractor.
Which laws sit behind the Swissmedic licence?
Articles 5, 18, 28 and 34 of the HMG (SR 812.21) and the AMBV (SR 812.212.1), according to Swissmedic.
What is a Swiss authorised representative under BauPG?
A person established in Switzerland whom a manufacturer has mandated in writing to act on its behalf (BauPG).
Is Switzerland a PIC/S member?
Yes. PIC/S lists Swissmedic with accession to the scheme in February 1996 (PIC/S, checked 1 November 2026).
Related guides
- Building a cleanroom inside an existing building
- What a cleanroom costs to run: energy, filters and testing
- The Cleanroom Project Lifecycle
- How to Import a Cleanroom from China
- 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