Equipment records for a DHA clinical laboratory licence
Dubai ties laboratory licence renewal to accreditation, and both DHA and DHCC name the equipment records they expect. What to have on file, and the MOHAP registration step.
Last reviewed August 11, 2026
Most guidance on laboratory equipment records talks about accreditation as something a lab chooses to pursue. In Dubai it is not optional in the way it is elsewhere: the health authority has tied it to the licence you already need in order to operate.
What the regulator actually says
The DHA Clinical Laboratory Accreditation Policy, reference DHA/HRS/HPSD/HP-12, Issue 5.1, was issued on 27 March 2023 and took effect on 27 May 2023. Clause 4.3 states that accreditation is a requirement for renewing the licence. The transition period the policy allowed has since closed.
Laboratories operating inside Dubai Healthcare Cityanswer to that free zone's own regulator instead. Its standard, DHCR/SD/HCO/012/01, requires accreditation within one year of commencing services (clause 3.6.2), and clause 3.6.4 is blunt about the consequence: the Clinical Operating Permit will not be renewed if the laboratory is not accredited.
Which accreditation body
The DHA policy is more open than most. Clause 4.2 accepts accreditation to ISO 15189 from any signatory of the ILAC Mutual Recognition Arrangement holding that scope — which covers the UAE's two national bodies, the Emirates National Accreditation System (ENAS) and the Emirates International Accreditation Centre (EIAC), and also foreign bodies such as Germany's DAkkS. It additionally names CAP and JCI.
The practical consequence is worth understanding: a laboratory in Dubai can hold accreditation from a body on another continent and still satisfy its local regulator, because ILAC mutual recognition is what the policy leans on. Medical testing to ISO 15189 is one of the six scopes that arrangement covers.
The equipment records the standards name
This is where a general ISO 15189 guide stops being enough. The DHCC standard does not simply point at the standard — clause 2.6 lists the inventory fields a licensed laboratory shall maintain for each unit of equipment:
- Name of the manufacturer
- Serial number
- Date of acquisition
- Record of contracted maintenance
Those four are a subset of what ISO 15189:2022 clause 6.4.7 asks for, but they are named explicitly in a licensing standard, which changes their status: they are not good practice, they are a condition of the permit. If your register cannot produce them per instrument on request, that is the gap to close first.
The MOHAP registration step
DHA standard ST-28, Issue 2 (effective 17 July 2023) adds something with no real analogue in most markets. Clause 6.5 requires that all equipment used in clinical laboratory settings be registered with the Ministry of Health and Prevention. Clause 5.5 separately requires documented evidence of equipment maintenance.
Registration is a per-instrument administrative fact with its own reference, and it is exactly the kind of thing that lives in someone's email until an inspector asks. Keep the reference against the instrument in the same register as everything else.
Where to start, if you are behind
- Establish what you actually own. One row per instrument with manufacturer, serial number and acquisition date — the three DHCC names first.
- Attach the cover. The contracted-maintenance record is the fourth named field. Most labs find at least one contract closer to expiry than they thought.
- Record the MOHAP registration reference against each instrument.
- Then the maintenance and calibration evidence. A schedule proves intent; completion records prove it happened. Assessors look for the second.
Common questions
Is laboratory accreditation mandatory in Dubai?
For a DHA-licensed clinical laboratory, accreditation is tied to licence renewal. The DHA Clinical Laboratory Accreditation Policy (DHA/HRS/HPSD/HP-12, Issue 5.1) states at clause 4.3 that accreditation is a requirement for renewing the licence. Laboratories in the Dubai Healthcare City free zone sit under a separate regulator, whose standard likewise ties the Clinical Operating Permit to accreditation.
Which accreditation bodies does the DHA accept?
The policy accepts accreditation to ISO 15189 by any ILAC-MRA signatory in that scope — which includes the UAE's own ENAS and EIAC, and foreign bodies such as Germany's DAkkS — as well as CAP and JCI. That is unusually open, and it means a Gulf laboratory can be accredited by an overseas body and still satisfy its local regulator.
Does this apply outside Dubai?
Not automatically. Each emirate licenses separately, and the other GCC states run their own arrangements. We checked Qatar, Kuwait, Oman and Bahrain and found no primary evidence that laboratory accreditation is compulsory for licensing in those four, so we do not claim it is. Saudi Arabia runs a different scheme through CBAHI, which is a healthcare-facility accreditation rather than an ISO 15189 laboratory one.
What is the MOHAP equipment registration requirement?
DHA standard ST-28 (Issue 2, effective 17 July 2023) states at clause 6.5 that all equipment used in clinical laboratory settings shall be registered with the Ministry of Health and Prevention. It is a registration step with no direct equivalent in most other markets, and it is worth tracking the registration reference against each instrument in your register.
Sources
DHA Clinical Laboratory Accreditation Policy DHA/HRS/HPSD/HP-12 Issue 5.1 (issued 27/03/2023, effective 27/05/2023), clauses 4.2 and 4.3 · DHA standard ST-28 Issue 2 (effective 17/07/2023), clauses 5.5 and 6.5 · Dubai Healthcare City standard DHCR/SD/HCO/012/01, clauses 2.6, 3.6.2 and 3.6.4 · ISO 15189:2022 clause 6.4.7 · ILAC Mutual Recognition Arrangement scopes. Regulatory documents change; check the current issue before relying on any of this.