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What are the fees of marketing authorization application and how long does it take to issue? FAQ

Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization? FAQ

What is Unique Device Identification (UDI) for Medical Devices? FAQ

What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track? FAQ

What does mean, “The timeframe for returned MDMA application is 60 calendar days” in announcement (8) 8/2019? FAQ

What are the requirements of soft contact lenses (Cosmetic and or/ Correction Lens) and contact lenses solutions? FAQ

what is In-Vitro Medical Device definition FAQ

How can i obtain marketing authorization of in vitro diagnostic device? FAQ

When does consider software program or electronic application as a medical device? FAQ

How you can transfer MDMA from previous AR to a new one FAQ