Submitting via the MeDevice Platform: Rules and Deadlines

1. Key takeaways

Medical device registration applications, import approvals, changes, and re-registrations in Egypt are all submitted through the EDA electronic platform MeDevice (medevice.edaegypt.gov.eg). The platform rules contain three hard constraints. First, persons dealing with the registration department must hold a formal power of attorney with a bank-certified (valid) signature. Second, uploaded documents must be originals, bear the company seal, and be signed by the legal representative. Third, only electronic documents formed by scanned upload or electronic signature are accepted, and no other forms of electronic document are accepted. Because every procedural clock in the Egyptian system starts from a platform-generated notice, the reliability of the account, the authorization papers, and the document formats is not an administrative nicety but the mechanical precondition of the entire regulatory timeline.

2. Legal basis

3. Expert insights

Insight 1: the system is not a hybrid of online filing plus offline follow-up, but platform-first with paper as an optional supplement.

Section 4.1.3 of GL.CAMD.002 provides that correction documents are sent through the platform, and Section 5.4 of GL.CAMD.003 states expressly that after all change documents have been completed on the platform, if a paper dossier needs to be submitted, the applicant’s registration representative books an appointment for its submission. In other words, the paper file is a conditional supplement, not a mandatory step. Teams that plan their Egypt submission around printing and courier logistics are solving yesterday’s problem; the operational plan should be built around platform readiness, account management, and digital document quality instead.

Insight 2: document format requirements catch more rejections than content does.

Section 4.1.3 lists four requirements: the documents must be originals; they must bear the company seal; they must be signed by the legal representative; and they may be submitted by scanned upload or electronic signature. The guideline also notes that no other electronic documents are accepted. The common failure modes are submitting internal working electronic copies, or using seal styles that were never authorized. A four-item format checklist applied to every document before upload eliminates most of this risk at negligible cost, and it should be a standing gate in the submission procedure.

Insight 3: the bank-certified power of attorney externalizes the question of who may represent the company.

Section 9, item 10 provides that dealings with the registration department must be conducted under the formal power of attorney of the company representative, and that the power of attorney must carry a bank-certified (valid) signature. The bank authentication here serves as an independent endorsement of the signature’s authenticity, which is more credible than corporate self-certification. The same requirement appears across registration, re-registration, and change procedures, so the authorization infrastructure should be built once and maintained continuously, rather than reconstructed for each filing.

Insight 4: the platform feedback cadence is the starting point of all procedural clocks.

After a registration application is submitted on the platform, the company receives feedback of acceptance, rejection, or suspension within 5 working days (fast track 3 working days), while import approvals are answered within 2 working days. All subsequent limits, such as the 90-working-day suspension correction period and the 60-working-day correction window, run from the platform feedback. The validity of the platform account and its notifications therefore directly determines whether deadlines are triggered. An unmonitored inbox or a lapsed account can silently consume correction windows that no appeal will restore.

Insight 5: a rejected application cannot reuse its number, while a suspended one can.

On the registration side, a rejected application must be started afresh, whereas a suspended application continues on the platform under the original application number while corrections are completed. The import approval rules are finer grained: the suspension correction period is 90 days, after which the review stops and the application is deemed rejected; thereafter it may be resumed within the following 90 days under the same application number, but the service fees must be paid in a lump sum, failing which the application lapses. Understanding this asymmetry determines whether a setback costs weeks or the whole file.

4. Practical recommendations

1. Arrange the account and authorizations before preparing the dossier: confirm that the registration applicant representative holds a bank-certified power of attorney before any upload.
2. Operate a document format checklist: originals, company seal, legal representative signature, and scanned upload or electronic signature, checked item by item for every file.
3. Treat platform notifications as the start of the clocks: assign a named person to monitor MeDevice notifications and the linked mailbox daily.
4. Remember that suspension is not rejection, but the time must be raced: complete corrections within 90 working days for registration and within 90 days for import approval.
5. Treat import-approval resumption as a single opportunity: service fees must be paid in one lump sum within the following 90 days, or the application lapses.
6. Keep platform screenshots and receipts: they are the evidence of deadline compliance and of every procedural milestone.

5. Verification checklist

• □ Completed account and entity registration on MeDevice
• □ The registration applicant representative holds a power of attorney with a bank-certified signature
• □ Uploaded documents satisfy the three requirements of originals, company seal, and legal representative signature
• □ Scanned upload or electronic signature has been used for submission
• □ A named person monitors platform notifications and the mailbox
• □ The deadline of the suspension correction period has been recorded (90 working days / 90 days)
• □ Platform receipts and milestone screenshots have been archived

Regulatory information verified as of October 29, 2026. The platform rules and document format requirements described in this article follow the current texts of EDREX: GL.CAMD.002, GL.CAMD.007, and GL.CAMD.003; when platform functions are adjusted, the content must be re-checked.

• Local Egypt support: GRZAN assists manufacturers from the Chinese mainland and overseas with medical device registration, import approval, and change applications before the Egyptian Drug Authority (EDA), including design of the registration applicant structure (importing company, local factory, or scientific office), preparation for Scientific Committee evaluation, advisory work on pathways for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the build-out of vigilance systems and periodic reporting.
• Service capabilities: product characterization and risk classification (devices Class I–III and IVDs Class A–D), registration and re-registration, determination of applicability of system registration and group registration, three-category determination of changes, import approval and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.