In the United Arab Emirates (UAE), before any medical device or pharmaceutical product can be registered, imported, or marketed, it must first undergo classification with the Ministry of Health and Prevention (MOHAP).
Classification is the first step in the regulatory process. It determines how a product will be evaluated, what level of documentation is required, and the degree of regulatory scrutiny applied. Without classification, the MOHAP registration process cannot begin.
Why Classification Matters
- Defines the regulatory pathway for each product.
- Ensures the correct level of safety and quality assessment.
- Helps manufacturers prepare the right documentation for registration.
- Protects patients by applying stricter standards to higher-risk products.
For both medical devices and pharmaceuticals, correct classification is crucial to avoid delays and rejections during registration.
Medical Device Classification
Medical devices are classified by risk level, in line with international frameworks such as IMDRF and EU MDR. The higher the risk, the more stringent the requirements:
- Class I (Low Risk):
Non-invasive devices with minimal risk.
Examples: surgical gloves, bandages, stethoscopes.
- Class IIa (Low–Medium Risk):
Devices with limited invasive use or diagnostic applications.
Examples: dental fillings, contact lenses, infusion sets.
- Class IIb (Medium–High Risk):
Devices with higher potential to cause harm.
Examples: anesthesia machines, diagnostic imaging systems, ventilators.
- Class III (High Risk):
Life-sustaining or life-supporting devices, or those implanted in the body.
Examples: pacemakers, orthopedic implants, cardiac stents.
Factors considered in classification include:
- Invasiveness of the device
- Duration of use (short-term vs. long-term)
- Mode of action
- Potential risk of harm
Pharmaceutical Product Classification
Pharmaceuticals are also categorized according to their nature and intended use. MOHAP generally divides them into the following groups:
- Prescription Drugs (Rx): Require a doctor’s prescription and are subject to strict evaluation.
- Over-the-Counter (OTC) Medicines: Approved for safe use without prescription, but still require MOHAP approval.
- Biopharmaceuticals & Biosimilars: Advanced therapies such as monoclonal antibodies or growth factors, requiring extensive clinical data.
- Vaccines & Injectables: Products for immunization or treatment that undergo rigorous safety and stability review.
- Nutraceuticals & Supplements (with therapeutic claims):
Classification of pharmaceuticals takes into account:
- Therapeutic purpose
- Active ingredients and formulation
- Route of administration (oral, injectable, topical, etc.)
- Potential risks and side effects
Classification as Part of MOHAP Registration
- Step 1: Classification (decides product category and risk class).
- Step 2: Manufacturer Site Registration (ensures factory compliance with GMP/ISO standards).
- Step 3: Product Registration (full dossier submission, evaluation, and approval).
Without completing classification first, product registration cannot proceed.
Trusted Support from ZEVANEX
At ZEVANEX Drug Store L.L.C, we guide manufacturers through the classification process with MOHAP, ensuring correct risk assessment and category assignment.
Our support includes:
- Preparing classification applications via the MOHAP portal.
- Reviewing technical documents to align with UAE regulations.
- Advising on whether a product falls under device, pharmaceutical, or supplement rules.
- Coordinating the transition from classification to site registration and product registration.
By managing this first step accurately, we help avoid delays and secure a faster path to market approval.
The Path Forward
Classification is the foundation of MOHAP registration. It determines how medical devices and pharmaceutical products are regulated in the UAE, ensuring patient safety and compliance with international standards.
With ZEVANEX as your partner, you gain regulatory expertise and local authority support to make classification smooth, accurate, and efficient — setting the stage for successful registration and distribution in the UAE market.