Clinical validation/investigation in Egypt - Medical Devices sevices that are not marked yet

RA Lille

Starting to get Involved
#1
Dear all,

Has anyone info about the documents to provide, authorization to get prior before conducting a clinical validation study pre CE mark or a clinical investigation post CE mark of Medical Devices in Egypt ?

Shall we provide IB (investigator brochure), CIP (Clinical Investigation Protocol), ICF (Informed Consent form) ? shall these documents be in English ? Arabic ?
Whom shall you send these documents ?
Is there any Ethical Comittee opinion to obtain ?

Could any foreign manufacturer conduct clinical investigation in Egypt ?
I saw that EPA, CAPA are responsible for authorizing and controlling MEdical Devices on the market. Probably for CE marked Devices, but what about devices that are not marked yet ?

thanks for sharing any info !
 

SKM.Sunil

Starting to get Involved
#2
As Per my Knowledge:

- RECs (research ethics committees) established under the Egyptian Ministry of Health, will review all the documents prior to giving approval to conducting a clinical trial in Egypt.
- If your device is new to the country then You must have/submit a valid clinical evidence (literature with your device if available) to prove the clinical performance with a minimum amount of population size. (Not only this point valid for Egypt but elsewhere in the Globe if Manufacture from a different country)

this link may help you more www.clinicaltrials.mohealth.gov.eg/Guidelines.pdf

All the Best
 

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Mallappa

Starting to get Involved
#3
Hello everyone,

I have one question regarding medical device clinical trial regulation in Egypt. It would be great help if you can answer below question.

To conduct clinical trial, Should client obtain an official approval letter from regulatory authorities like MOH or CAPPA even after obtaining IRB approval from local institute of Egypt, which is selected to perform the study?

Thanks in advance.
 

Mallappa

Starting to get Involved
#4
hello everyone,

I have few questions with regards to clinical trials requirements in Egypt. It would be great help if you can answer below questions.

I am trying to understand what is in writing (e.g. documented as a requirement related to clinical trial regulation/guidance, privacy laws, personal (health) information, etc) required in Egypt.
  • Central Lab: Can central labs be utilized for clinical trials? If so, what are the requirements? (The CRO says a CT can only be done if a central lab is not used. I highlight doubt this given some of the information required for CTA by the HA and trial approval by the IRB/EC
    • What is the typical time to get a central lab setup for a study?
  • Human Samples: Can human tissue and biological samples or materials be exported outside of Egypt for processing and analysis? If so what are the requirements? If not, how does the HA advise Sponsor to conduct analysis of samples collected from subjects? (Note: the CRO says Egyptian regulations prohibit shipping of samples for testing outside of Egypt and we are not so sure about this)
  • Monitoring: Does Egyptian law mandate that CRAs have to be based in Egypt? If there are restrictions, what is allowed in terms of procuring CRAs for monitoring services (Note: this is another one I highly doubt considering it appears Egypt allows foreign CROs to manage trials provided they have annual approved registration. Also the CRO acknowledges that CRAs from neighboring countries like Jordan can also be utilized, so this doesn’t add up to me).
Thanks in advance!
 

SKM.Sunil

Starting to get Involved
#5
hello everyone,

I have few questions with regards to clinical trials requirements in Egypt. It would be great help if you can answer below questions.

I am trying to understand what is in writing (e.g. documented as a requirement related to clinical trial regulation/guidance, privacy laws, personal (health) information, etc) required in Egypt.
  • Central Lab: Can central labs be utilized for clinical trials? If so, what are the requirements? (The CRO says a CT can only be done if a central lab is not used. I highlight doubt this given some of the information required for CTA by the HA and trial approval by the IRB/EC
    • What is the typical time to get a central lab setup for a study?
  • Human Samples: Can human tissue and biological samples or materials be exported outside of Egypt for processing and analysis? If so what are the requirements? If not, how does the HA advise Sponsor to conduct analysis of samples collected from subjects? (Note: the CRO says Egyptian regulations prohibit shipping of samples for testing outside of Egypt and we are not so sure about this)
  • Monitoring: Does Egyptian law mandate that CRAs have to be based in Egypt? If there are restrictions, what is allowed in terms of procuring CRAs for monitoring services (Note: this is another one I highly doubt considering it appears Egypt allows foreign CROs to manage trials provided they have annual approved registration. Also the CRO acknowledges that CRAs from neighboring countries like Jordan can also be utilized, so this doesn’t add up to me).
Thanks in advance!
Hello Mallappa
1.Central Lab 2. Samples
Collected samples may be very difficult to transfer to other countries considering the facts transportation, customs clearance, cost and country-specific restricted laws.

Its ideal is to have a central lab in place (in Egypt). You can set up a central lab from any of the government approved labs. You can choose any labs according to your requirements and go with an agreement( this is a link to govt. accreditation site, you can find a list... EGAC - HOME PAGE - )

3. Normally any country requires a CRA with a fluent understanding of local Language to better monitoring the activities and communications. as far as my knowledge there are no such restrictions in Egypt regarding CRA of foreign countries unless he/she doesn't understand the local language. Any CRA with International GCP and Egyptian GCP or applicable national regulation trained/certified can do the job.

Hope this help in a few aspects.
 

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