{"id":3524,"date":"2017-07-25T10:43:24","date_gmt":"2017-07-25T08:43:24","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=3524\/"},"modified":"2023-10-06T09:58:37","modified_gmt":"2023-10-06T07:58:37","slug":"medical-device-registration-u-a-e","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-u-a-e\/","title":{"rendered":"Medical Device Registration in U.A.E."},"content":{"rendered":"
\"emirati<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Ministry of Health and Prevention (MOHAP), Drug Control Department (DCD)<\/p>\n

Classification<\/strong><\/h5>\n

MD: I, II, III, IV<\/p>\n

IVD: A, B, C, D<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016<\/p>\n<\/div>

<\/i><\/span>The information on this page is valid and current as of January 2023. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

Medical Devices are regulated by the Ministry of Health (MoH) through the Registration and Drug Control Department (DCD).<\/p>\n

UAE regulations state that the only parties authorized to carry out device registration are the Medical Device Manufacturer if it is based in the territory or otherwise its Local Representative, who may act on behalf of the former only with prior authorization.
Before starting the Medical Device or Establishment registration process, it is necessary to complete the registration with MOHAP and obtain a valid license to import and market in the UAE.
The Manufacturer must submit the application for product registration to the Competent Authority, the documentary complexity of which depends on the classification of the device. However, registration of Medical Devices in the UAE must include data on efficacy as well as safety: if ascertained and the MoH approves the registration, a certificate and an identification number is issued that allows the import\/sale of the registered Medical Device in the UAE.
There are some types of devices that do not require registration or prior approval for import and are regulated at the time of import itself.<\/p>\n<\/p>\n

Applicant<\/span><\/h3>\n

Foreign manufacturers must appoint a UAE resident company to act as the Authorized Representative.
The Authorized Representative must be licensed by MOHAP and the facility he\/she owns must have a pharmacist in charge (PIC) licensed to practice pharmacy in the UAE, who is also in charge of the facility.<\/p>\n

Timeframe and fees<\/span><\/h3>\n

Product classification: 10-14 working days; fee per application: USD 136
Manufacturer registration license: 14-28 business days; fee per application: USD 2859
Product registration: 45 working days; fee per application: USD 1360<\/p>\n

Validity<\/span><\/h3>\n

Registration license or listing: 5 years or until suspended or revoked by the Authorities.
Registration validity is subject to submission of post-marketing surveillance reports every 2 years for certain high-risk devices (III, IV and implantable) defined by the Drug Registration and Control Department that require special attention.<\/p>\n

Labelling and documentation language<\/span><\/h3>\n

Labelling and documentation should be provided in English.<\/p>\n

Useful information<\/span><\/h3>\n

No local testing is required. All Manufacturers, including foreign Manufacturers, must register their manufacturing facility as part of the device registration process. Manufacturers of Class III or IV devices may be subject to an audit with on-site inspection.
The vigilance system for Medical Devices should be implemented and updated every two years by the Manufacturer and\/or Local Representative: a record of distribution procedures should be kept, as well as records of reporting adverse incidents, and procedures should be in place to promptly and effectively perform investigations and recalls of defective Medical Devices.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n