Registration Process of Medical Devices in Dubai
The healthcare industry in Dubai has experienced significant growth over the years, with a rising demand for innovative medical devices. However, bringing a medical device to market requires adherence to specific regulations and a comprehensive registration process. The MOHAP plays a crucial role in regulating and controlling the import of medical devices in the UAE. Before selling medical devices in the country, it is mandatory to register them with the MOHAP
In this article, we will explore the step-by-step registration process for medical devices in Dubai, ensuring compliance with the local regulatory framework.
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Types of Medical Devices requiring Registration
Types of Products that Require Registration: Medical devices encompass various products, including tools, machines, implants, in vitro reagents, calibrators, and operating software, intended for use on humans or animals without pharmacological, immunological, or metabolic effects. The devices serve purposes such as diagnosing and treating illnesses, injuries, or disabilities, preventing and monitoring diseases, controlling conception, and investigating physiological processes or anatomy modifications.Classification of Medical Devices:
Medical devices are classified into four classes based on the level of risk associated with their usage. When applying for medical device registration in the UAE, applicants must understand these classes. Classification Rules for Medical Devices and In Vitro Diagnostics (IVDs):- Class I (Low-risk devices)
- Class II (Low-to-moderate risk devices)
- Class III (High-to-moderate risk devices)
- Class IV ( High-risk devices)
Documents required for Registration of Medical Device
To successfully register a medical device with the UAE MOHAP, the manufacturer or its representatives need to submit a range of information and documents. The following documents are necessary for completing the medical device registration process: Product information, including description, formulation, types, sizes, models, accessories, usages, side effects, contraindications, warnings, precautions, usage guidelines, photos of packaging covers, brochures, and user manuals. Copy of the Authorization Agreement between the company and distributor/representative Stability Studies: Stability studies play a crucial role in the development, manufacturing, and regulatory approval of medical devices. These studies are carried out to evaluate the performance, validity, and safety of medical devices over time, specifically in terms of their physical, chemical, and functional properties. Manufacturers can ensure that medical devices maintain their intended quality and functionality throughout their shelf life and usage by subjecting them to various environmental conditions and monitoring their stability. Classification of Medical Devices: Medical devices in Dubai are classified into four categories based on their risk level. Class I devices pose the lowest risk, while Class IV devices present the highest risk. It is crucial to determine the classification of your medical device before initiating the registration process. If Medical Device falls in Class III or Class IV category CE Mark and Design Examination Certificate is required. Preparing the Required Documentation: To initiate the registration process, the following documents are typically required: a) Manufacturer’s ISO Certification: A copy of the ISO 13485:2016 certification, demonstrating compliance with international quality management standards, is necessary. b) Free Sale Certificate: A Free Sale Certificate issued by the manufacturer’s country of origin indicates that the medical device is freely available for sale in that country. c) Product Information: Detailed information about the medical device, including its technical specifications, intended use, labeling, and instructions for use, must be provided. d) Clinical Data: Clinical evaluation reports, evidence of safety and performance, and any relevant clinical trials data should be included to support the safety and efficacy of the device. e) Quality Management System or CE Mark Certificate: A description of the quality management system used during the manufacturing process is required, including details of quality control and assurance procedures. Technical Review and Testing: In certain cases, the regulatory authorities may request additional technical documentation or conduct testing on the medical device to ensure its safety and performance. These tests may include electrical safety, electromagnetic compatibility, and biocompatibility tests. Principle of Safety and Performance Checklist: The principle of safety and performance checklist is a comprehensive set of criteria and requirements that medical device manufacturers need to consider and address during the development and evaluation of their products. It ensures that medical devices meet the necessary safety and performance standards to protect the health and well-being of patients and users. The Declaration of Conformity (DoC) is a crucial document in the field of medical devices. The manufacturer or authorised representative typically issues a DoC certifying that the medical device complies with all applicable regulatory requirements and standards. It contains information about the manufacturing site, the type of medical device, the UPNs of the medical device, and its accessories. Approval and Registration: Upon successful completion of the review process, the regulatory authorities will issue an approval/registration letter, granting permission to market the medical device in Dubai and this letter is valid for 5 Years. Post-Market Surveillance: Once the medical device is registered, it is essential to comply with post-market surveillance requirements. This includes monitoring adverse events, maintaining a complaint handling system, and reporting any issues to the regulatory authorities within the stipulated timeframe. Let our consultants to submit professionally the product application.Let Cosmereg assist you with your Medical Device Registration process:
Navigating the registration process for medical devices in Dubai requires careful attention to detail and compliance with regulatory standards. By understanding the classification system, preparing the necessary documentation, and adhering to the review and approval processes, manufacturers can successfully register their medical devices in Dubai’s growing healthcare market. It is crucial to engage with local experts and authorized representatives to ensure a smooth and efficient registration process while ensuring the safety and quality of the medical device.
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