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MOHAP Risk Classes I-IV
UAE MOHAP Regulatory Strategy & Product Classification
Classification Should Establish the Entire UAE Regulatory Route. The UAE pathway should begin with product qualification, intended purpose and the regulatory status of the product — not with a registration form. MOHAP's classification service can determine whether a product requires MOHAP registration and provides a formal classification outcome based on the information submitted.
When This Support Is Needed
Introducing a new medical device, IVD, software, or combination product into the UAE market
Formal confirmation is required regarding whether the product requires MOHAP registration
Borderline product qualification (medical equipment vs cosmetic vs general consumer product)
Structuring a device family, kit, system, or accessory grouping for registration filing
An engineering modification or clinical claim expansion may alter the established risk class
What We Challenge Before Submission
Does the product's primary mode of action qualify it as medical equipment under MOHAP definitions?
Will a clinical claim on marketing leaflets push a borderline product into a higher medical device class?
Do all system accessories and consumables share the same classification rationale?
Does the product catalogue align with the regulatory authorization in the country of origin?
Has a formal MOHAP classification letter been obtained to avoid customs clearance delays?
Our Classification & Strategy Support Scope
Product qualification and UAE federal regulatory-status assessment
Intended purpose, clinical indications, claims, and target user-population review
Class I, II, III, and IV risk classification assessment for medical equipment/devices
IVD Class I-IV risk classification and analytical route determination
Assessment of accessories, procedure kits, systems, and model families
Software as a Medical Device (SaMD) and digital health regulatory status assessment
Review of country-of-origin (COO) and reference-country (EU, US, Japan) regulatory authorizations
Product catalogue, packaging labels, leaflet, and technical brochure readiness
MOHAP Product Classification Service application filing and official letter receipt
Assessment of whether another UAE authority (e.g. MOIAT / ECAS, Dubai Municipality) applies
Comprehensive regulatory roadmap connecting classification to registration dossier depth
Strategic Regulatory Rule:
We do not treat classification as a label. We use it to determine evidence depth, registration route, local applicant requirements, technical documentation, testing, labeling and post-market obligations.
Determine Your MOHAP Medical Device Classification
Our UAE regulatory specialists evaluate intended purpose, submit classification requests, and obtain formal MOHAP classification letters.