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Medical Device Registration Guideline Registration and Drug Control Department Ministry of Health UAE 2011 1 Acknowledgement This guideline was prepared by a technical team under the supervision.
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Microbial FAQ
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Medical devices in the UAE are categorized into four risk-based types (Class I, II a, II b, and III) under the jurisdiction of the Drug Control Department of the Ministry of Health (DCD MOH).
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The United Arab Emirates' Ministry of Health and Prevention (MOHAP) is the government authority in charge of medical device registration, as well as regulations for other medical products, including prescription and over-the-counter pharmaceutical products.
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Registration of a Medical Equipment | Services | Ministry of Health and Prevention - UAE.
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The MOHAP is the authority in charge of all medical products and devices within the UAE. They cover all matters set out in the Pharmaceutical Law. All medical devices must be registered and licensed whether including those registered in other jurisdictions.
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The medical device regulation (MDR) or European Union medical device regulation (EU MDR) is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe.
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FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products. In the U.S., FDA regulates the sale of medical device products.
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Required Documents Valid MOHAP medical store license. Valid MOHAP license of Pharmacist in-charge, or Medical Equipment Engineer Certificate attested by the UAE Ministry of Education- for medical store that has activity of only non-pharmaceutical medical devices.
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Filling out the application form of registration completely and to be signed and stamped by company. A copy of valid registration certificate of the factory. A valid certificate of free sale/ registration issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.
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