Unlocking Market Access: The Impact of Official Classification with MOHAP on Medical Device Registration in the UAE

Introduction

Medical device classification with the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) is vital for ensuring patient safety, achieving Regulatory compliance, and determining registration requirements. The classification is risk-based, with four (04) types (Class I, IIa, IIb, and III), and is overseen by MOHAP’s Registration and Drug Control Department. It ensures compliance, streamlines registration, and safeguards public health. The UAE’s classification system aligns with the European Union Medical Device Regulation (EU MDR), ensuring consistency and simplifying international trade. Medical device classification is risk-based, guiding the level of scrutiny and evaluation needed for registration. Higher-risk devices undergo rigorous evaluation with additional safety and efficacy evidence. Understanding this classification is crucial for stakeholders, as it helps determine specific requirements and documentation for compliance with MOHAP.

Benefits of Classification

• Determining the Registration Requirements: MOHAP’s official classification determines the necessities for product registration. The classification letter identifies requirements, helping manufacturers and importers understand the registration process.
• Ensuring Compliance with Regulations: MOHAP’s official classification ensures Regulatory compliance, evaluating product safety and efficacy for public health protection.
• Facilitating the Registration Process: MOHAP’s classification streamlines registration, providing clarity to manufacturers and importers on requirements for preparing the documentation.
• Protecting Public Health: MOHAP’s classification safeguards public health by ensuring that only safe and effective products are available in the UAE market, thus protecting people from potential harm.
• Providing Clarity on Required Documents: MOHAP’s classification provides clarity on the required registration documents, guiding manufacturers and importers in the preparation of the necessary paperwork.

 Conditions

Required Documents

 Emirates Identification (ID)/passport or trade license/drug store license (depends on the user type).

The official classification with MOHAP has brought about a transformative impact on the medical device registration process in the UAE through the implementation of a comprehensive system. To know more about MOHAP medical device classification and gain clarity on the registration procedures, which can lead to faster and more efficient approvals for medical devices, reach out to us today. Stay informed! Stay compliant!

• The classification letter is not a registration certificate or approval for marketing a product in the UAE. It only provides preliminary classification based on the applicant’s submitted data, and the applicant is solely responsible for the accuracy of the information. MOHAP bears no responsibility in this regard.
  1. The letter informs the applicant about the UAE regulations for their products and lets them know whether MOHAP registration is necessary.
  2. If, based on the classification, MOHAP registration is required, the applicant must follow the specified class for the registration process. This ensures compliance with the Regulatory requirements, ensuring the safety and quality of the medical devices sold in the UAE market.
  3. The letter is valid for only three (03) years from the date of issuance.
• If the classification result states that “MOHAP registration is not required” for the product, it means that the product comes under the jurisdiction of other competent authorities in the UAE. In such instances, the applicant is responsible for contacting the relevant authorities and adhering to the regulations governing their specific areas of supervision. It can be directly imported.

  Such authorities include the Dubai Municipality, the Emirates Authority for Standardization and Metrology, the Ministry of Environment and Water, and other official UAE entities.

  • For medical devices with numerous accessories/supplies, the applicant needs to provide a table listing their names and code numbers (if any). The table should bear the stamps of the manufacturer/supplier abroad and the local agent. If the list spans multiple pages, each page should be stamped, and the complete list should be attached to the classification application.
  • For products with multiple sizes, the applicant can include all the sizes in one application. However, products with variations in models/configurations/uses/dosage forms are considered separate applications.
  • Devices and their accessories are treated as a single product, and the corresponding fees are applied accordingly.
  • For first aid bags and kits, each item within the group is treated as a separate product. Fees are applied accordingly for each item.
  • Dentistry kits for specialized doctors are classified as follows: tools and equipment of the same group are grouped under one application, while products with pharmaceutical and chemical substances are placed under separate applications. Fees are applied accordingly.
  • Applicants for products granted “clearance from MOHAP as medical device, restricted to use by professionals” must obtain online clearance from the Importation/Drug Department at MOHAP, following applicable procedures. The applicant must include a copy of the clearance letter along with other quality-related documents. These products are cleared solely for medical stores licensed by MOHAP and are supplied only to licensed healthcare facilities (MOHAP/Department of Health [DOH]/Dubai Health Authority [DHA]) within the UAE. Supplying them to patients is prohibited by UAE laws, and any breach of rules would lead to permit cancellation and legal consequences.
  • Medical devices with patient data processing software must comply with the UAE Federal Law No. 2 of 2019.
  • Product catalogue for medical devices and product picture.
  • Certificate from the authorities in the country of origin related to the product (Certificate of Pharmaceutical Product [CPP]/Free Sale Certificate/Conformité Européenne [CE]/International Organization for Standardization [ISO]).
  • Registration and marketing status in other countries (the applicant needs to attach copies of the certificates), if applicable.
  • Leaflet/product information in English/Arabic.
  • Inner pack and outer pack label with clear and readable product name and information (artwork).
  • Composition certificate (active/inactive ingredient list, with the quantity of each ingredient)/Material Safety Data Sheets (MSDS), which are applicable for products containing medicinal/chemical ingredients.