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

3

3l5m4r

#1
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
 
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#3
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
 

tibon74

Involved In Discussions
#4
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!
 
M

miken99

#5
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.
 

tibon74

Involved In Discussions
#6
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.
 

Ronen E

Problem Solver
Moderator
#7
My question was what are needed documents to approve medical devices (all classes) in Egypt.
Please refer to posts #2&3 above. I don’t 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.
 

tibon74

Involved In Discussions
#8
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.
 

Ronen E

Problem Solver
Moderator
#9
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.
That’s understood. Please let me clarify:

1. I was not protesting against your quest, nor trying to disuade you from looking / asking for this information. I merely expressed my feeling that in the current context Elsmar is already sort of depleted. This is based on my search for relevant threads, the number of people that have requested this kind of information here over the past years, and the almost complete lack of answers. I believe that if they were available they would have already been in our database. I know that it’s a little disappointing, given that more such information is available for other countries, but this database is in no way uniform. On some countries there is simply less information documented than on others.

2. I generally agree regarding distributors, but I wrote “knowledgeable and reliable local”, which doesn’t have to be a distributor. The important attribute is being Arabic (or Egyptian) literate. Have you tried to contact Emergo? What was the outcome, if you don’t mind sharing?
 

tibon74

Involved In Discussions
#10
Thank you for your clarification. I agree that Elsmar was more efficient.
Emergo is very expensive (like other third parties) and should pay for everything
 
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