Ministry of Health Product registration
Dubai is very conscious about maintaining the safety and standard of the products in its market, especially medical products. Ministry of Health and Prevention (MOHAP) is charged with regulating pharmaceutical and medical products. It maintains a high standard for consumers to have the best experience. The products are evaluated and tested before registration.
Key reasons to for medical and pharmaceutical product registration:
- Ensures product safety and efficacy before market entry
- Complies with national and international regulatory laws
- Protects public health through quality assurance
- Builds consumer trust and credibility in the product
- Prevents distribution of counterfeit or substandard products
- Enables legal marketing and sales in target markets
Businesses can’t trade their products without the certificate of registration from the Ministry of Health. The registration process involves filling the application, meeting the conditions and requirements, and providing the right documents.
The registration remains valid for five years. This guide walks you through everything you should know about registering products with Ministry of health in Dubai, UAE. It will assist you in avoiding any challenges along the way.
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Pharmaceutical Products Requiring MOHAP Registration
- Medicines
- Medical devices
- Supplements
- Items with Therapeutic Claim
- Disinfectants
Medicines are substances used to treat or prevent illnesses. The two main types include prescription medicines, which need a doctor’s note, and over-the-counter (OTC) medicines, which you can buy without having a doctor’s prescription. Prescription examples includes Antibiotics and Panadol is an example of OTC
Medical devices are tools, machines, or instruments used to diagnose, monitor, or treat health problems. They can be simple or advanced, depending on their use. For Example thermometers, blood pressure monitors, X-ray machines
Supplements are products taken to improve health. Supplements usually contain vitamins or minerals. Herbal products also come under MOHAP. They are made from plants and are often used for healing, e.g. vitamin C tablets, ginger capsules
This includes the products that claim that they can cure or help with certain medical problems. Even if they are not medicines, they must be checked by health authorities to make sure they are safe. The examples in this category include creams that claim to reduce pain, oils that help with sleep
These are chemicals used that kill germs and keep medical tools and areas clean. They are important for preventing infections. Examples include hand sanitizers, surface disinfectant sprays used in hospitals
Steps to Medical & Pharmaceutical Product Registration
Sign up with MOHAP and find the registration portal. Foreigners have to register their products through an authorized local agent. Business must be registered and have a valid license. Prepare all the documents and information that is to be submitted.
Provide all the information required and attach the documents. Ensure the completeness and validity of both. Pay the required fee after confirming the quote.
After the submission of the application, the ministry will review your information and product. It must meet all the regulatory and safety requirements. Additional information, documents or samples may be requested.
The Ministerial committee or Technical Committee is responsible for evaluating the product and deciding whether its compliant to the requirements or not. The reports by drug department are also reviewed. Answer any further queries if asked.
Upon committee approval, you will receive the certificate of registration. It will allow you to trade and manufacture the licensed products in the UAE legally. All companies must follow this process for their products.
Understanding MOHAP Registration Process in the UAE
These products are delicate and have an important purpose. They cannot be left unchecked in the market. Therefore, the evaluation is necessary. Businesses must meet all the regulatory requirements to get registration certificate.
Difference Between Mainland & Free Zone Online Business
- Mainland
- Free Zone
The mainland licenses are regulated by the Department of Economic Development (DED). It provides several benefits to online businesses. Here are some of the highlights:
- You can trade freely within the UAE market
- UAE residents and foreign investors can get government support
- Mainland partnerships may be better for the long term
Free zones are regulated by their own authority, offering many benefits to new e-commerce businesses in Dubai. Some of the highlights about free zone setup include:
- Free zones in Dubai offers 100% foreign ownership and tax benefits
- Limited to operating within the Free Zone
- License issued by Free Zone authority with simplified setup
Your Best Banking Options in the UAE
Emirates NBD
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RAKBANK
RAKBANK was founded in 1976 and focuses on helping individuals and small businesses. It offers both regular and system compliant to Islam. The bank’s strength is in simple services, e.g. fast opening, and easy loan access for startups and freelancers.
First Abu Dhabi Bank
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ADCB
Abu Dhabi Commercial Bank began in 1985. It is known for smart digital services. It focuses on saving time for users through applications and online tools. It has strong customer service and tech-based growth. Among the best for personal and corporate banking.
Emirates Islamic Bank
This bank started in 2004. It is known for blending laws of Islam with modern tools. It was the first shariah bank to launch WhatsApp banking. Its main strength is offering Shariah-compliant products with easy access and user-friendly digital support.
Benefits of Ministry of Health Product Registration
Legal market access
Public health safety
Quality is verified
Builds trust fast
Blocks fake drugs
Boosts brand image
Easier global reach
Aids in tenders
Supports insurance
Regulatory approval
Regulatory Conditions and Requirements for Service Process
- Applicant must have a UAE-based pharmaceutical or medical device company license from relevant authorities
- Products must be manufactured in GMP-certified facilities approved by international or local regulatory bodies
- All ingredients and components must comply with UAE standards and not be listed as banned substances
- Complete technical documentation, including product composition, labels, and stability data, must be submitted
- Clinical data proving safety and efficacy must be included, especially for new pharmaceutical substances
- A UAE-licensed local agent or distributor must be appointed to represent the foreign manufacturer
- Market authorization holder companies must ensure approval from country of origin or recognized authorities
- Packaging and labeling must meet Arabic and English language requirements and display accurate product details
- Fee payment for product evaluation and registration must be completed as per MOHAP's prescribed guidelines
- Medical devices must have risk classification and conformity certificates like CE, FDA, or ISO approvals
Required Documents for Registration of Pharmaceutical Products
- Product registration application
- Valid trade license copy
- GMP certificate of manufacturer
- Certificate of pharmaceutical product
- Free Sale Certificate (FSC)
- Ingredients list with composition
- Product artwork and labeling
- Stability study summary report
- Clinical trial data (if needed)
- Authorization letter from MAH
- Manufacturing license copy
- ISO or CE certificate (if device)
- Local agent/distributor agreement
- Safety Data Sheet (SDS)
- Batch release certificate
- Packaging materials samples
Required Documents for Businesses
- Valid trade license
- Commercial registration certificate
- Memorandum of Association (MOA)
- Emirates ID of all signatories
- Passports of all shareholders
- Proof of operating address
- Board resolution (if applicable)
Common Mistakes & Solutions When Opening a Mashreq Account
Wrong Account Choice
Mistake: Choosing an account that does not suit your needs can cause problems later.
Solution: Check account features and pick the right type (salary, savings, etc.).
Missing Documents
Mistake: Submitting incomplete or incorrect papers can delay your application.
Solution: Double-check all documents before applying. Ask the bank for a checklist.
Ignoring Online Option
Mistake: Not using Mashreq’s app may cause extra effort and time.
Solution: Try Mashreq NEO for fast and easy online account opening.
Low Balance Maintenance
Mistake: Not maintaining required balance can lead to fines (for some accounts).
Solution: Choose zero-balance salary account if you want to avoid this issue.
Delaying First Deposit
Mistake: Not making the first deposit on time may keep your account inactive.
Solution: Deposit the required amount soon after opening the account.
Common Mistakes in Registering Pharma &
Medical Products
Missing Paperwork
Mistake: People often miss important documents or provide outdated documents. This gets them in trouble.
Solution: Hire professional consultants to help you with the paperwork or put extra importance upon it.
Ineligible local agents
Mistake: Foreigner manufacturers and companies often get in contact with ineligible agents who waste their time and money.
Solution: Always research who you hire and confirm credibility. Contact IBG Consultancy for a detailed consultancy session.
Incorrect labeling
Mistake: People ignore the labeling laws, which is a huge mistake. Labels have to be clear and bilingual.
Solutions: Always hire professionals for design and double check if your final label meets the requirements before putting it up for review.
Common Mistakes in Registration Process & Solutions
Downgrading the Quality
Mistake: Many companies downgrade the standard of their products to save costs. It’s a huge mistake.
Solution: Provide the best production possible and ensure it meets the standards of the Dubai market.
Messing the Paperwork
Mistake: Owners unaware of the requirements often mismanage the paper work. They provide wrong, invalid or incomplete documents, etc.
Solution: Do thorough research on what documents you need to submit. It’s best to seek professional help for accuracy.
Providing invalid Information
Mistake: Owners make the mistake of submitting the wrong or invalid information. Some provide invalid trade license.
Solution: Providing the right and complete information is of most importance. Ensure you submit it right or seek professional help.
Register Your Products in Dubai with IBG in 4 Simple Steps
Book a Free Consultation
Consult with our experts to assess your product and registration needs.
We Handle the Documents
We prepare and review all required documents with complete accuracy.
Fast-Track Submission
Your application is submitted quickly through our direct links with authorities.
Get Your Certificate
Receive your certificate and start selling your product legally in the UAE.
Why Choose IBG Consultancy for Registration with MOHAP
Only the products licensed by the Ministry of Health can be traded and manufactured in Dubai, UAE. It is high time to legalize your products in the markets of the United Arab Emirates. Contact us today and get your products registered with ease.
Frequently Asked Questions
Who can submit applications to register medical products in Dubai?
Any licensed business in Dubai with a valid trade license and a local agent can submit applications to register their products.
What types of certificates are required from competent authorities?
How long are registration certificates valid after issuance by MOHAP?
Are there specific committees that deliberate the registration of products?
Is it mandatory to have a local agent for product registration for foreigners who could register their products?
What documents must be included in the registration file?
Can products approved in other countries be eligible for registration here?
What is the role of the medical warehouse licensed by the ministry in product registration?
How does the service process handle applications for registering pharmaceutical items?
Are recommendations issued by the competent technical and ministerial committees necessary for approval?
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