Welcome to Medical Regulations Gate
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(Sat - Thursday)
Kingdom of Saudi Arabia
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Services in KSA

Registering Manufactures site for Medical Device Establishment License (MDEL) with the Saudi FDA.
Registering Medical Device Marketing Authorization (MDMA) with the Saudi FDA on behalf of the manufacture.
Communicating with Saudi FDA of any changes in the product or any information about the manufacturer.
Assisting manufacturers with their post-marketing and vigilance reporting.
Classifying products with the Saudi FDA
Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA
Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA
Assisting the manufacturer with their UDI submission to the Saudi DI database