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Medical Device Registration Egypt: Only required for Sterile Medical Devices?

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egypt, egyptian moh (ministry of health), medical device registration
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  Post Number #1  
Old 5th April 2017, 08:19 AM
3l5m4r

 
 
Total Posts: 19
Question Medical Device Registration Egypt: Only required for Sterile Medical Devices?

Hi-

Quick question: I've found some information on medical device registration in Egypt on this website.

A (local) customer keeps telling me that medical device registration is only required for sterile devices (which we currently don't intend to market in Egypt). I've found no such information on said website (or anywhere else), however.
(It could be stated somewhere in Arabic, but I don't speak Arabic.)

Can we go ahead and market our non-sterile devices without registration?

(I'd be glad, if you could back up your answer with (ideally official) sources.)

-el5m4r

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  Post Number #2  
Old 5th April 2017, 08:23 PM
Ronen E

 
 
Total Posts: 3,736
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

You can contact Emergo. They have an office in Cairo.
  Post Number #3  
Old 10th April 2017, 05:16 AM
sreenu927

 
 
Total Posts: 541
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

In Egypt, the regulating authority is Ministry of Health (MoH). Under MoH, there are DPPC - Drug Policy and Planning Center and CAPA - Central Administration of Pharmaceutical Affairs.
Egypt follows EU Classification of Medical devices.
DPPC is responsible for reviewing and approving Class I, IIa and IIb medical devices. These products can be sold while registration is under review.
Class III medical devices are registered at CAPA and can be sold only after receiving approval. CAPA also manages Sterile , Single-use devices regardless of classification.
Hope this helps!

Regards
Sreenu
Thank You to sreenu927 for your informative Post and/or Attachment!
  Post Number #4  
Old 2nd October 2017, 01:02 PM
tibon74

 
 
Total Posts: 135
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

Hi all,

What are documents needed for class I, IIa, IIb and III products ?
How much time it takes to het the approval ?
Thank you!
  Post Number #5  
Old 2nd October 2017, 01:50 PM
miken99

 
 
Total Posts: 22
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

In the US, and I believe in Europe as well, regulators require UDI registration of all medical devices regardless of sterilization. It does not seem logical that they would have Egypt set up differently. This is intended to be a global effort to combat supply chain problems.

I would not market a device without approval. it could be a disaster for someone, maybe you. They have the power to make you recall all items, or worse.
  Post Number #6  
Old 2nd October 2017, 02:01 PM
tibon74

 
 
Total Posts: 135
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

In US it is required for class II and III. For class I it will be in 2018. UDI is not required fur Europe (expected in the new regulation). and I do not think that it is required for Egypt
My question was what are needed documents to approve medical devices (all classes) in Egypt.
  Post Number #7  
Old 2nd October 2017, 09:20 PM
Ronen E

 
 
Total Posts: 3,736
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

Quote:
In Reply to Parent Post by tibon74 View Post

My question was what are needed documents to approve medical devices (all classes) in Egypt.
Please refer to posts #2&3 above. I donít believe you will find much more information online (other than, maybe, in Arabic), and so I think your best bet is a knowledgeable & reliable local.
  Post Number #8  
Old 3rd October 2017, 02:11 AM
tibon74

 
 
Total Posts: 135
Re: Medical Device Registration Egypt: Only required for Sterile Medical Devices?

Hi, the goal of this forum is to share information we have. I was able to get this kind of information for other countries thanks to Elsmar. The distribtors are not a reliable support. Their first goal is the business.
For your information, Eda site describs needed documents but a little bit confusing.
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