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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.

Cleanroom contractor for Saudi Arabia: design, supply and installation

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).

FacilityRegulator and rule
Drug factorySFDA, Guide to Good Manufacturing Practice for Medicinal Products
HospitalCBAHI accreditation, required by Cabinet decree 371
Imported goodsSASO, 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

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

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