Scientific Committee Evaluation: Triggers, Process, and Outcomes

1. Key takeaways

Egypt’s dedicated Scientific Committee system is the single largest time variable in the registration process. Under Section 5 of EDREX: GL.CAMD.002, the devices that must be submitted for dedicated Scientific Committee evaluation before registration include: devices imported from non-reference countries or locally produced, filed for new registration or re-registration; devices submitted in order to determine whether the differences between them are substantial, and whether they should be registered separately or combined; devices containing a dosage form, evaluated for safety and efficacy, for prescription or non-prescription status, and for label claims and the intended use stated in the instructions for use; devices that safety department reports recommend for committee review, or that require an opinion from the committee; and devices submitted to the committee for clarification of technical points. The committees are divided into specialties according to the use of the device. Because referral is triggered by status rather than by discretion, manufacturers should treat committee time as a designed-in stage of the plan rather than an exceptional detour.

2. Legal basis

3. Expert insights

Insight 1: for Chinese manufacturers, the non-reference-country import trigger is a certainty, not a contingency.

The first category of referral trigger under Section 5 is exactly the devices imported from non-reference countries or locally produced, filed for new registration or re-registration. Since China is not on the 37-country reference-country list, new registrations and re-registrations of products manufactured in China will in principle all go before the committee. This is not a lottery ticket that may or may not be drawn; it is a built-in component of the pathway. Budgeting and scheduling that treat the committee as an unlikely event will be structurally wrong from day one, so the committee window must appear in every project plan for Chinese-made products.

Insight 2: the committees are divided by specialty, and the referral depends on the device’s use.

The guideline states that the scientific committees are divided by different specialties, and that the committee to which a device or equipment is referred is determined by its intended use. Referral is therefore not random: the company should identify the relevant specialty before submission and prepare the dossier in the terms that specialty expects. Misjudging the specialty leads to re-referral, which silently re-enters the queue and consumes weeks that no status query will recover.

Insight 3: committee decisions take three forms, and suspension is a conditional, recoverable state.

The guideline lists the decision forms as approval, reasonable suspension with reasons, and rejection with reasons. Where a matter is suspended, the requirements must be completed through the MeDevice platform, after which the file is resubmitted to the committee. Suspension is therefore not a rejection, but the file re-enters the queue. The practical consequence is that a suspended project needs a second round of waiting time in the schedule, and the reasons given for suspension should be answered completely in one correction cycle to avoid repeated loops.

Insight 4: whether differences are substantial is decided by the committee, which directly shapes the registration unit structure.

The second category of referral under Section 5 covers devices submitted for new registration or re-registration so that the committee may opine on whether the differences between the devices are substantial and whether they should be registered separately. This links to the single registration number rule in Section 11.1: devices that share the required elements but differ in others have their grouping decided by committee opinion. A combined registration strategy that looks efficient on paper can be undone by a substantiality finding, so the grouping rationale should be documented before the committee sees it.

Insight 5: devices containing a dosage form undergo three additional assessments.

For dosage-form devices referred to the committee, the evaluation covers safety and efficacy, prescription or non-prescription (OTC) status, and the claims on the label and the intended use in the instructions for use. In substance, these three assessments determine whether the product crosses the boundary into the pharmaceutical or OTC domain. Manufacturers of combination products should prepare all three lines of argument together, since a weakness in any one of them can reshape the entire regulatory classification of the product in Egypt.

4. Practical recommendations

1. Schedule committee review as the default stage: products manufactured in China are handled as non-reference-country imports, so reserve committee time for both new registrations and re-registrations.
2. Prepare the referral documents early: assemble the documents required for submission to the dedicated Scientific Committee according to Annex VII of GL.CAMD.007.
3. Determine the specialty in advance: identify the committee specialty to which the device should be referred based on its intended use.
4. Reserve a second round for suspension, correction, and resubmission: after a suspension, requirements must be completed on the platform and the file re-queued.
5. Prepare the three additional arguments for dosage-form devices: safety and efficacy, prescription or non-prescription status, and label claims and instructions for use.
6. Obtain the committee’s opinion on differences before combined registration: avoid a split being imposed later after a substantiality finding.

5. Verification checklist

• □ Confirmed whether the product triggers committee review (non-reference-country import / local production)
• □ Assembled the referral documents according to Annex VII of GL.CAMD.007
• □ Identified the specialty committee to which the product should be referred
• □ Reserved a second round of time for suspension, correction, and resubmission
• □ Prepared the three arguments required for dosage-form devices
• □ Obtained the committee’s opinion on differences before combined registration

Regulatory information verified as of October 29, 2026. The Scientific Committee referral triggers and decision forms described in this article follow the current texts of Section 5 and Section 7 of EDREX: GL.CAMD.002 Version 2 and Annex VII of GL.CAMD.007; when the guidelines are revised, 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.