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Medical Devices · MOHAP Registration · Ministry of Health & Prevention

MOHAP Registration UAE — Medical Device & Healthcare Product Approval

If you operate in the healthcare, pharmaceutical, or medical device industry, obtaining approval from the UAE Ministry of Health and Prevention (MOHAP) is essential before any product can enter the market. From medical device classification to full MOHAP registration in the UAE, every healthcare product must meet strict regulatory requirements.

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Registered pathways

  • Dubai Municipality
  • Montaji / CPRE
  • MOHAP
  • ESMA
  • Dubai Customs
  • Free Zone Authorities
Overview

What CPRE registration covers — and why it matters.

Nextmove provides expert support for MOHAP product registration, medical device classification, and regulatory licensing, ensuring your healthcare products comply with UAE healthcare regulations. Our team guides manufacturers, importers, and distributors through the entire approval process — helping you secure MOHAP regulatory approval efficiently and without unnecessary delays. With our dedicated MOHAP registration services in the UAE, businesses can avoid costly mistakes, documentation errors, and long approval times. We manage the full process from product evaluation and medical device classification to final submission through the official MOHAP regulatory system, helping your products enter the UAE healthcare market faster.

  • Full dossier preparation and pre-audit
  • Device classification and technical file/labeling compliance review
  • Direct submission via the MOHAP/EDE e-services portal
  • Query handling with the authority
  • Approval certificate delivered digitally
  • Post-approval customs support
Categories

Product categories we register.

From single-device imports to full multinational healthcare portfolios, we handle every product category regulated under MOHAP and the Emirates Drug Establishment (EDE).

Import Clearance Support

Import Clearance Support

Our MOHAP import clearance service helps healthcare companies obtain the required permits for importing medical devices and pharmaceutical products into the UAE. We assist with regulatory documentation, customs approvals, and compliance with Ministry of Health and Prevention requirements.

Medical Device Classification

Medical Device Classification

Medical device classification is a critical step in the MOHAP registration process. Devices are categorized based on risk levels to determine the regulatory pathway required for approval. Our experts help companies identify the correct classification to ensure smooth product registration.

Medical Device Registration

Medical Device Registration

Medical device registration with MOHAP ensures healthcare products meet UAE safety and regulatory standards. We assist manufacturers and distributors with documentation preparation, regulatory submissions, and compliance to obtain market approval.

Authorized Representative Services

Authorized Representative Services

Foreign manufacturers must appoint an authorized representative in the UAE for MOHAP medical device registration. Our service ensures regulatory communication, documentation management, and compliance with UAE healthcare authority requirements.

How it works

A five-step pathway to approval.

Every engagement follows the same structured pathway. You always know what stage you're at, what's next, and who's handling it.

  1. Step 01

    Consultation

    Free 30-minute call to map your category, timeline and cost.

  2. Step 02

    Dossier audit

    We review formulations, artwork, and manufacturer documents.

  3. Step 03

    Submission

    Full CPRE submission via the Montaji portal with our specialist.

  4. Step 04

    Query handling

    We manage authority feedback and clarifications on your behalf.

  5. Step 05

    Approval

    Digital approval certificate delivered — ready for customs.

Documentation

What MOHAP registration covers — and why it matters.

Requirements vary slightly by sub-category, but the core dossier is consistent. We audit every document before submission so nothing bounces back.

  • Medical device classification & risk-tier assessment
  • Full regulatory dossier preparation & documentation review
  • Direct submission via the MOHAP e-services portal
  • Authorized representative services for foreign manufacturers
  • Import permit & customs clearance support
  • Query handling & correspondence management with the authority
Timeline & investment

Transparent timelines. No hidden fees.

Indicative ranges based on typical cases. Exact scope and fees are confirmed after your free consultation.

Category Typical timeline Common approvals
Medical Device (Low risk – Class I/A) 15–20 working days EDE (formerly MOHAP)
Medical Device (Medium risk – Class II/III, B/C) 20–35 working days EDE
Medical Device (High risk – Class IV/D, IVD) 30–45+ working days EDE
Healthcare/Pharma Product (verified pathway – prior FDA/EMA/MHRA approval) 3–6 months EDE
Import Permit (per shipment, post-registration) 3–10 working days EDE, Customs
FAQ

MOHAP registration, answered plainly.

Still have questions? Our regulatory specialists respond within 24 hours.

Is it still called "MOHAP registration" in 2026?
Most people still search and refer to it that way, and MOHAP remains the parent federal health authority. But as of December 2025, product registration and marketing authorization actually run through the newly created Emirates Drug Establishment (EDE), which took over this function from MOHAP. MOHAP now focuses on facility and professional licensing.
How long does MOHAP/EDE registration actually take?
It depends heavily on product type and risk class. Medical devices generally clear in 15–45 working days depending on classification. Pharmaceutical products can take 9–18 months for a full new-generic dossier, or as little as a few months if the product already has approval from a recognized authority like the FDA, EMA, or MHRA (verification pathway).
What documents do I need to prepare?
The core dossier typically includes a Free Sale Certificate, GMP/manufacturing certificate, full technical or ingredient file, product labeling and artwork, and a manufacturer authorization letter. Medical devices additionally need classification and risk-analysis documentation. Exact requirements shift slightly by category.
What documents will I need to prepare?
Typically a Free Sale Certificate, GMP certificate, INCI list, artwork, product photos, MSDS and a manufacturer authorisation letter.
Do foreign manufacturers need a UAE-based representative?
Yes. Overseas manufacturers can't submit directly — an authorized representative or local licensed distributor based in the UAE must file and manage the application on their behalf. This is a mandatory requirement, not optional.
How do I check my registration status after applying?
Once submitted, you can track progress through the MOHAP/EDE e-services portal using your application reference number. We monitor this for clients throughout classification, technical review, and final approval, and flag any authority queries as soon as they come in.
Free consultation

Ready to start your MOHAP/EDE registration?

Book a 30-minute call with our regulatory specialists. We'll map the fastest pathway for your category and share a clear cost and timeline estimate.

Visit
Iliya Tower 1, Office #207, Dubai, UAE

Fill out the form and our team will be in touch within 24 hours.

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