Inside the EDA: CAMD Organisational Structure for Devices

1. Key takeaways

The concrete management of medical devices in Egypt is carried out by the Central Administration for Medical Devices (CAMD) under the EDA. Its Medical Devices Registration General Directorate comprises six units: the Device Inspection and Evaluation Department, the Local Devices Registration Department, the Imported Devices Registration Department, the Device Changes Department, the Scientific Committee Unit, and the Devices Registration Committee Unit. Nearly every procedural contact a company has in Egypt lands in one of these six units. Critically, submitting an application to the wrong department is one of the statutory grounds for outright rejection, and this type of rejection cannot be cured by correction. Knowing the org chart is therefore not administrative detail; it is a submission gate that must be cleared before any dossier is uploaded to the platform.

2. Legal basis

3. Expert insights

Insight 1: separate registration departments for local and imported devices signal that the two procedures differ.

The CAMD places the Local Devices Registration Department and the Imported Devices Registration Department side by side, mirroring two distinct procedures: imported devices follow Section 4.2.1 of GL.CAMD.002, while local devices follow Section 4.2.2 or GL.CAMD.09. One frequently overlooked consequence is that if the manufacturing-site status of a product changes, the file may move from the imported department to the local department. A company localizing production of a previously imported device is not merely updating an address; it is switching procedural channels, with different document lists, different timelines, and potentially a different reviewer. Route planning should anticipate that switch before it happens.

Insight 2: the Device Inspection and Evaluation Department performs technical file review, not site inspection.

Despite the word inspection in its name, this department concentrates on the examination and evaluation of technical documentation. Actual physical sampling belongs to the Medical Devices Inspection Department: GL.CAMD.09 provides expressly that for locally manufactured devices not holding international quality certificates, the Medical Devices Inspection Department draws samples from the trial production batch and sends them to EDA laboratories or other EDA-accredited institutions for analysis. Confusing the two departments leads to misdirected correspondence and wasted waiting cycles. File evaluations, deficiency letters, and technical questions go to the evaluation side; sample logistics go to the inspection side.

Insight 3: the Scientific Committee Unit and the Registration Committee Unit operate at two different levels.

The Scientific Committee Unit organizes the specialized scientific committees, which are divided by specialty according to device use and issue scientific opinions on safety and efficacy. The Registration Committee Unit instead handles appeals: within 60 days of receiving a rejection letter, the applicant may submit an objection letter for evaluation by that committee, and if the objection is still rejected, a second appeal may be filed within 60 days of receiving the rejection notice. Keeping the two units distinct in the project plan matters because one is a forward-looking scientific review that precedes approval, while the other is a remedial mechanism triggered only after an adverse decision.

Insight 4: submitting to the wrong department is a statutory ground of rejection, and it cannot be remedied.

Section 4.1.1 of GL.CAMD.002 lists among the grounds for rejection that the application does not fall within the jurisdiction of the department to which it was submitted, and GL.CAMD.007 contains the same wording for import approvals. This rejection is not the kind that a correction cycle can rescue: the file must simply be resubmitted, and the clock starts again. The only effective countermeasure is a pre-submission jurisdiction check that records, in writing, which department owns the application type, the product origin status, and the certificate situation.

Insight 5: the decisions of several departments link into a single chain.

A single application may pass in sequence through acceptance at a registration department, technical evaluation by the Device Inspection and Evaluation Department, safety evaluation by the vigilance side, Scientific Committee review organized by the Scientific Committee Unit, and finally certification by the registration department. A negative opinion at any link sends the application back to the platform for correction. Project schedules should therefore be built as a chain of dependent stages rather than as a single review period, so that a setback at one stage does not silently corrupt the plan for all subsequent stages.

4. Practical recommendations

1. Determine the responsible department before submitting: use the three dimensions of local versus imported, registration versus changes, and whether committee review is needed, and record the conclusion in the submission plan.
2. List wrong-department submission as a mandatory pre-submission check: it is a rejection ground that cannot be cured, so it deserves its own sign-off line.
3. Reserve time for the Scientific Committee stage: new registrations and re-registrations of non-reference-country imports and of locally manufactured devices generally require committee review.
4. Route appeals through the Registration Committee Unit: submit the objection letter within 60 days of the rejection letter, and remember the second appeal also carries a 60-day limit.
5. Reserve sampling time for local products without certificates: the inspection department will draw samples from the trial production batch, so the batch must exist before the application is filed.

5. Verification checklist

• □ Confirmed the responsible department for the application (local / imported / changes)
• □ Confirmed whether Scientific Committee evaluation is required
• □ Ruled out wrong-department submission as a rejection ground
• □ Reserved time for sampling and laboratory analysis (local no-certificate pathway)
• □ Noted the appeal route and deadlines (60 days / a further 60 days)
• □ Confirmed on MeDevice that the application is routed to the correct department

Regulatory information verified as of October 29, 2026. The organizational structure described in this article follows the organizational structure page currently published on the EDA website, and the procedural statements follow the current texts of the EDREX guidelines; when the institution is reorganized, 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.