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
Staff member
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
Staff member
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
 
Thread starter Similar threads Forum Replies Date
N Changing a Medical Device distributor in Egypt Other Medical Device Regulations World-Wide 7
R Clinical validation/investigation in Egypt - Medical Devices sevices that are not marked yet Other Medical Device Regulations World-Wide 4
X Egypt In Vitro Diagnostics Medical Devices Registration Other Medical Device Regulations World-Wide 2
3 Egypt: Multiple Registrations of the Same Product Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
C ISO17020 Required to ship disposable "coveralls/overgarments" into Egypt General Measurement Device and Calibration Topics 6
M Egypt is calling - Some Information about Egypt Coffee Break and Water Cooler Discussions 0
T How do you think Egypt looks like?! Coffee Break and Water Cooler Discussions 21
Marc Cats - Egypt to Today - Scourge or 'Friend'? Pls - No More Cat recipes! Coffee Break and Water Cooler Discussions 100
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Informational Good news: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation EU Medical Device Regulations 3
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
dgrainger Informational Consultation on the future regulation of medical devices in the United Kingdom UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
K System of medical devices EU Medical Device Regulations 0
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
D Dental application - medical product or not? Other US Medical Device Regulations 8
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
J Shoe Covers - medical device class I EU Medical Device Regulations 3
A Are pipette heads "medical devices"? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Statistics and / or Forecasts on medical products exports from China Other Medical Device and Orthopedic Related Topics 1
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
F Medical cart self certification EU Medical Device Regulations 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 2

Similar threads

Top Bottom