Country guide: UAE
Cleanroom contractor in the UAE: rules and import steps
In the UAE the regulator approves the owner's facility, not the contractor: the Emirates Drug Establishment (EDE) for medicine and medical product factories, and a health authority for hospitals. Regulated imported goods need a conformity certificate from the Ministry of Industry and Advanced Technology (MoIAT), applied for by a business holding a UAE licence.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
EDE launched in February 2026. It had licensed 37 facilities making human pharmaceutical and medical products (Gulf News, 9 February 2026). It applied for PIC/S pre-accession on 5 March 2026, and PIC/S appointed a rapporteur on 15 July 2026 (PIC/S, 28 July 2026).
The Dubai Health Authority (DHA) guidelines have six parts, A to F. Part B covers functional units, including the operating unit. DHA says its guidelines yield to existing laws where the two conflict (DHA, checked 31 October 2026). For a site outside Dubai, ask the owner which health authority applies.
| Facility | Authority and rule |
|---|---|
| Medicine and medical product factory | EDE facility licence |
| Hospital in Dubai | DHA Health Facility Guidelines |
| Regulated imported goods | MoIAT conformity certificate |
Who builds cleanrooms here
EDE's 37 licensed production facilities are the clearest buyers. EDE also oversees the Holistic National Manufacturing Project, which covers the pharmaceutical chain from active ingredients to distribution (Gulf News, 9 February 2026). Hospitals are the other group.
What a foreign supplier must arrange
MoIAT's service page for regulated products lists three documents: a valid UAE industry or trade licence, a test report from an accredited laboratory, and an online declaration of conformity (MoIAT, checked 31 October 2026). A foreign supplier therefore needs a UAE licensed business to apply. Ask MoIAT, through that business, which items on your list are 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. State the emirate and whether EDE or a health authority will inspect. Give the name of the UAE licensed business that will deal with MoIAT.
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 EDE approve cleanroom contractors?
No. EDE licenses the owner's production facility. The owner chooses the contractor.
Which guidelines cover hospital design in Dubai?
The DHA Health Facility Guidelines, Parts A to F. Other emirates may use other rules, so ask the owner (DHA, checked 31 October 2026).
Is EDE a PIC/S member?
Not yet. It applied for pre-accession on 5 March 2026 (PIC/S, 28 July 2026).
Who applies for a MoIAT conformity certificate?
A business with a valid UAE industry or trade licence, with an accredited laboratory test report and an online declaration of conformity (MoIAT, checked 31 October 2026).
Related guides
- How long does it take to build a cleanroom?
- Building a cleanroom inside an existing building
- What a cleanroom costs to run: energy, filters and testing
- The Cleanroom Project Lifecycle
- Turnkey cleanroom contractor
- Room list builder
Sources
- Gulf News, UAE ramps up local medicine manufacturing with launch of Emirates Drug Establishment (9 February 2026)
- PIC/S, Uzbekistan applies for PIC/S membership, page also listing the UAE EDE pre-accession application (28 July 2026)
- Dubai Health Authority, Health Facility Guidelines (checked 31 October 2026)
- MoIAT, Issue conformity certificates for regulated products (checked 31 October 2026)
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