Egyptian Drug Authority

 
Services > Registration > Medical device

Medical Device
About Us 
The Medical Device Registration department is in charge of evaluation, classification, registration of single –use, locally produced or imported medical device. It is also in charge of setting up all regulation and requirements for the registration of medical devices. 

Regulations 

 What’s a Medical Device? 
 Medical Device classification 
 Decisions of Technical Committee 
 Decisions of technical committee related to medical device safety 
 Impotant Announcement Concerning ISO Certificate 13485 (Modified) 

Publication issued from Head of Central Administration of Pharmaceutical Affairs

      
 Publication No (12)/2012 
       Publication No (18)/2013 

Regulations 

 Medical Device Registration Flowchart 
 Registration reports had been cancelled according to technical committee decision 

Reception Section of Medical Device 

 How to set an appointment to submit a registration file 
 Application form 

Check lists 

       Imported 
       Local 
       Procedure Pack 
       Imported class I non -sterile 
       Local class I non-sterile 

 Front office schedule 

Scientific Committee Requirement 

 Requirement for Scientific committee 

Stability Committee Requirement 

 Application form 
 File content 
 Guidelines for Stability study report 

Variation Department 

 Arabic 
 English 

Registered Medical Devices 

 Registered medical devices (2006-2007-2008)
 Registered medical devices till 2012
 Registered medical devices (2013-2014-2015)

FAQs
 

 FAQs 
 
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