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

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