MOHAP Registration – Step by step Guide 2025
Registration with MOHAP has a processing time of 30 to 90 days and a fee ranging from AED 2,000 to 25,000 based on the type of product. This applies to health products, medical devices, cosmetics, and food supplements sold in UAE. If you have proper documentation, success rate is 85%.
What is MOHAP Registration?
MOHAP fullform is Ministry of Health and Prevention. It is the UAE federal authority regulating medicinal and health products.
Registration is mandatory for:
- Medical devices (Class I-III)
- Pharmaceuticals and medicines
- Food supplements and vitamins
- Cosmetics and personal care
- Health foods and functional foods
- Medical equipment and diagnostics
Without the approval from MOHAP, no health product can be brought into the country, distributed, or sold in the UAE.
The main categories in MOHAP are Medical Devices Class I, Medical Devices Class II, Medical Devices Class III, Pharmaceuticals, Food Supplements and Cosmetics.
Registration Process Overview
Step 1: Pre-Registration Assessment takes 1-7 Days
Q: What are the steps to find out if my product is eligible for registration with MOHAP?
A: You can either use the online classification tool or the product database available at mohap.gov.ae.
Pre-Registration Checklist:
- Check product classification
- Check if product already registered by another company
- Verify compliance of manufacturing facility
- Check documentation requirements
- Calculate budget and time required
Required Company Prerequisites:
- Valid UAE trade license
- Responsible person qualification certificate
- Quality management system
- Local authorized representative
Step 2: Document Preparation takes 8-21 Days
Main Documentation needed:
For All Products:
- Application form (online submission)
- Trade license copy
- Product specifications and intended use
- Manufacturing license from country of origin
- Certificate of free sale from home country
- Good Manufacturing Practice (GMP) certificate
- Product samples (as requested)
- Arabic labelling mock-ups
- Authorization letter from manufacturer (if distributor)
Additional documents are required depending upon the category – Medical Devices, Pharmaceuticals, Food Supplements.
Step 3: Submitting Online Application which takes 22-28 Days
Q: How do I submit my MOHAP application?
A: Visit and create account at mohap.gov.ae/services.
Submission Process:
- Create account on MOHAP portal
- Select product category and registration type
- Fill all the details of application form
- Upload documents in PDF format ensure it is not more than 10MB each
- Pay registration fees online
- After submitting the application, you will receive reference number
- Keep the receipt for records
Acceptable Payment Methods:
- Credit/debit cards
- Direct bank transfer
- Government payment channels
Step 4: MOHAP Review Process takes 29-75 Days
Review Timeline by Category:
Fast Track usually takes 21-30 days: Products which can opt for this are
Class I medical devices / Basic cosmetics / Simple food supplements
Standard Track takes 45-60 days: this is for
Class II medical devices / Complex cosmetics / Nutritional supplements
Extended Review take around 60-90+ days:
Class III medical devices / New pharmaceuticals / Novel health products
Review Stages:
- Initial Screening – Document completeness check
- Technical Review – Expert evaluation
- Compliance Assessment – GMP and quality verification
- Final Approval – Certificate generation
Step 5: Answering Queries -Days 30-60
Q: What to do when MOHAP requests additional information?
A: You have 30 days to respond which stops during query response period.
Common Query Types:
- Missing documents
- Labelling corrections
- Technical clarifications
- Additional testing
Response Best Practices:
- Respond within 15 days (faster processing)
- Provide complete information to avoid follow-up queries)
- Use official letterhead for communications
Reference application number in all correspondence
Step 6: Certificate Issuance at around Days 76-90
Final Approval Process:
- Payment confirmation of final fees
- Certificate generation
- Digital certificate available on portal
- Physical certificate delivery (optional)
Certificate Validity:
For Medical Devices and Pharmaceutical is 5 years (renewable) and for Food Supplements and Cosmetics is 3 years (renewable)
