Egypt - Register a Medical Device

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Procedure

Apply In Person

1. To Register a Medical Device, the applicant has to approach the Egyptian Drug Authority (EDA) link
2. An application form will be provided to the applicant by the concerned officer.
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
9. Then the application will be processed further.
10. The officer will review the application and may request additional information or clarification if necessary.
11. If the NHRA determines that the device meets the requirements, it will issue an approval and registration certificate. This certificate allows the device to be legally marketed and sold in Bahrain.
12. After registration, the NHRA may conduct post-market surveillance activities to monitor the safety and performance of the medical device. Compliance with applicable regulations and reporting of adverse events may be required.
13. This entire process can be completed within 3 – 4 weeks or as per the timeline advised by the respective department authority.

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Required Documents

• Application form
• Address proof – (Driving license, passbook, utility bill, etc)
• National Identity (NID) Card
• Technical specifications
• Declaration of conformity
• Quality system documentation
• Safety and effectiveness data
• Local agent authorization
• Fee receipt
• Any other documents (If required)

Office Locations & Contacts

Egyptian Drug Authority (EDA)
21 Abdel Aziz Al Saud Street, Al Rawda, Cairo Governorate
Phone - 02 25354100
Email - [email protected]
Contact link

Eligibility

• Any individual or an organization who intends to Register a Medical Device is eligible to make this application.

Fees

• The applicant has to pay the prescribed fee as requested by the authority.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• This entire process can be completed within 3- 4 weeks or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name
• Nationality
• Gender
• Age
• Email ID
• Fax
• Medical device details
• Technical specifications
• Mobile No
• Email Address
• Educational Qualifications
• Date
• Signature

Need for the Document

• Registering a medical device in Egypt is the process of legally obtaining authorization from the Central Administration for Pharmaceutical Affairs (CAPA) to market a medical device in Egypt.
• This process involves submitting the necessary documentation and fees to CAPA and meeting certain regulatory requirements.

Information which might help

Here are some of the benefits of registering a medical device in Egypt:

• You can legally market your medical device in Egypt.
• You can gain access to the Egyptian market, which is a growing market for medical devices.
• You can build trust with Egyptian patients and healthcare professionals.
• You can comply with Egyptian regulations, which can help to protect patients and healthcare professionals.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

link

Others

More information which might help people.