When introducing health-related products into the UAE market, one of the key regulatory steps is ensuring compliance with the Ministry of Health and Prevention (MOHAP). Among the essential procedures is the MOHAP Product Classification, a mandatory step that determines under which regulatory framework your product falls, and whether it requires formal registration with the Ministry or other related authorities.

 Purpose of MOHAP Product Classification

The MOHAP classification serves to identify the nature of a product based on its composition, claims, and intended use. This helps determine whether the product will be regulated as a cosmetic, supplement, medical device, pharmaceutical, or general consumer product.

The primary objectives of this process include:

• Ensuring public health and safety through proper regulation
• Preventing misleading product claims
• Directing products to the correct registration and approval pathway
• Streamlining importation and sale within the UAE

 Products That Require MOHAP Classification

Products that often require classification under MOHAP include (but are not limited to):

• Food supplements and herbal products
• Topical patches and pain relief gels
• Feminine and hygiene products
• Disinfectants and sanitizers (with medical or antibacterial claims)
• Medical devices and diagnostic kits
• Health-related cosmetics (with claims beyond cosmetic purposes)

Essentially, any product that has a therapeutic, preventive, or health-related claim should first undergo classification to determine if it falls under MOHAP’s regulatory scope.

 Document Requirements

To initiate the classification, the following documents are typically required:

1. Emirates ID or the applicant’s passport or trade license or drug store license (depends on the user type) (mandatory)
2. Certificate from the regulatory authority of the country-of-origin, related to the submitted product (copy of the CPP/free sale certificate/CFG/CE/ISO) along with English or Arabic translation (mandatory) [CPP: Certificate of pharmaceutical product; CFG: Certificate to foreign government; CE: European conformity; ISO: International organization for standardization with submitted product name]
3. A photo of the product (mandatory)
4. Leaflet/product information in English/Arabic (mandatory)
5. Product catalogue for medical devices
6. Inner pack label with clear and readable product name and information (artwork)
7. Outer pack label with clear and readable product name and information (artwork)
8. Composition Certificate (Active/ Inactive ingredient list with each ingredients quantity)/ MSDS (applicable for product that have Medicinal/Chemical Ingredients in it) MSDS: Material Safety Data Sheet.
9. Registration and Marketing Status in other Countries (Copy of the Certificates along with English or Arabic Translation from Reference Countries approved by UAE MOHAP (Reference Country List Attached Above) / CE Certificate from EU approved Notified Body for the submitted Product) [CE: European Conformity. EU: European Union.]
10. Product Sample in their Final Original Pack (Upon Request)
11. MOHAP Quality Control Lab Analysis Report (Upon Request)
12. Letter of Authorisation from Marketing Authorization Holder (Upon Request)

 MOHAP may request additional documents depending on the product’s nature and intended use.

Conditions and requirements

1. The purpose of the Classification letter is to inform you about the laws governing your products within UAE.
2. The classification letter identifies the product classification if the product needs or does not need registration by MOHAP. If it is determined that it needs registration by MOHAP, it must be registered in MOHAP according to the class identified in the classification letter.
3. Classification is available for all types of Companies and for Individuals.

 Service Timeframe

The classification process generally takes 10 to 15 working days from the date of submission, provided that all documents are in order and no further clarifications are required by the authority.

Upon completion, MOHAP issues an official classification report, indicating under which regulatory category the product falls and the next steps for registration or market approval.

 How Bizzmosis Can Assist:

At Bizzmosis Group, we specialize in guiding companies through the entire MOHAP classification and registration process. Our services include:

• Assessing your product and advising on the correct classification path
• Preparing and submitting all required documentation to MOHAP
• Coordinating with the authority for clarifications or additional requirements
• Assisting with establishment registration and product approval
• Ensuring compliance to avoid delays or rejections

Our goal is to simplify the process for you, ensuring smooth, compliant, and timely approval of your products for the UAE market.

📩 Planning to enter the UAE market or register a health-related product? Let Bizzmosis handle the complexity, so you can focus on growth.

📞 +971 52 979 8169 | 📧 hello@bizzmosis.com