Country guide: Saudi Arabia
Cleanroom contractor for Saudi Arabia: design, supply and installation
In Saudi Arabia the regulator approves the owner's facility, not the contractor: the Saudi Food and Drug Authority (SFDA) for drug factories and CBAHI for hospital accreditation. Imported goods go through the SABER platform, which the Saudi importer uses to register products and shipments.
By ZY Cleanroom · Updated · Sources at the end of the page
What ZY does for a project in Saudi Arabia
ZY designs cleanrooms and makes the cleanroom panels and doors in its own factory in Tianjin, China. The air system, windows, air showers and pass boxes are supplied in the same quotation. Choose turnkey, design and supply, or supply only.
Site work is delivered with a licensed local contractor named in the contract: yours, or one agreed with you. ZY supplies numbered drawings, an installation guide, remote video support for set-out and the first panels, and on-site supervision for larger projects.
Panels are cut to length, numbered to the layout drawing and packed on timber pallets in Tianjin. Give us the site city and we plan the route. Send a room list or floor plan for a first scope and budget range.
The rules below decide what your facility needs; your regulator approves the facility.

Which rules apply to your facility
SFDA publishes the Guide to Good Manufacturing Practice for Medicinal Products (document OPS-G-080, Version 4.4). SFDA joined the PIC/S inspection scheme in July 2023 (PIC/S, checked 31 October 2026).
The Ministry of Health's Hospital Commissioning Checklists, first edition of October 2020, tie facility items to CBAHI standards (Ministry of Health).
| Facility | Regulator and rule |
|---|---|
| Drug factory | SFDA, Guide to Good Manufacturing Practice for Medicinal Products |
| Hospital | CBAHI accreditation, required by Cabinet decree 371 |
| Imported goods | SASO, SABER platform |
Who builds cleanrooms here
Official data from the Ministry of Industry and Mineral Resources, reported on 26 August 2024, counted 206 pharmaceutical and medical device factories. That is 56 SFDA-licensed pharmaceutical factories and 150 medical device factories, up 200% since 2018 (Arab News, 26 August 2024). Hospitals are the other large group, because CBAHI accreditation covers them.
Import steps through SABER
SASO runs SABER. Only importers, SASO-approved certification bodies and Saudi customs officials can access it (trade.gov, 25 May 2021).
A product certificate of conformity is required before shipment and is valid for one year. A shipment certificate is required for each consignment (trade.gov, 25 May 2021). A foreign supplier therefore needs a Saudi importer with a SABER account. Ask that importer which items on your list SASO treats as regulated.
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. Say whether the building is new or existing. State whether SFDA, CBAHI or both will inspect. Give the name of your Saudi importer.
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. Certification and testing 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 SFDA approve cleanroom contractors?
No. SFDA inspects the owner's drug factory against its GMP guide. The owner chooses and manages the contractor.
Is CBAHI accreditation compulsory?
CBAHI states that accreditation is a national requirement under Cabinet decree number 371 (CBAHI FAQ, checked 31 October 2026).
Can a foreign supplier register goods on SABER?
Not directly. Only importers, SASO-approved certification bodies and customs officials have access (trade.gov, 25 May 2021).
How many drug and device factories does Saudi Arabia have?
206 in official data reported on 26 August 2024: 56 pharmaceutical and 150 medical device factories (Arab News, 26 August 2024).
Related guides
- The Cleanroom Project Lifecycle
- Building a cleanroom inside an existing building
- How to audit a cleanroom panel factory, on site or by video
- What a cleanroom costs to run: energy, filters and testing
- Turnkey cleanroom contractor
- Room list builder
Sources
- PIC/S, list of participating authorities (SFDA, PIC/S Scheme from July 2023; checked 31 October 2026)
- SFDA, Guide to Good Manufacturing Practice for Medicinal Products, Version 4.4, OPS-G-080 (checked 31 October 2026)
- CBAHI, FAQs (checked 31 October 2026)
- Ministry of Health, Hospital Commissioning Checklists, 1st edition, October 2020 (checked 31 October 2026)
- Arab News, Saudi pharma and medical device factories surge to 206 (26 August 2024)
- trade.gov, Saudi Arabia requirements to certify imports (25 May 2021)
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