Three Categories of Registration Licence Variations in Egypt Explained

1. Key takeaways

Section 6.1 of EDREX: GL.CAMD.003 Version 3 divides Egyptian variations into three categories with different official names and different consequences. Do and tell (act first, report after) covers three items: changing the registration applicant’s name at the same address, changing the applicant’s address, and changing internal and external labelling data or embedded instructions for use where the change is not major; goods are not seized, but the applicant must undertake to report the change to the variation department. Tell and Do (report first, then act) covers ten items, including adding, deleting or cancelling codes (including USP suture codes), transferring or adding manufacturing sites or countries of origin, changing shelf life, adding or changing the sterilisation method, changing the registration applicant’s name, changing the manufacturer’s name at the same address, changing the legal manufacturer’s address, changing or adding the legal manufacturer, changing, adding or cancelling packaging, and major internal and external labelling or IFU changes; the device may not be placed on the market without an application and an initial acceptance number, and a one-year grace period runs from acceptance of the documents. Tell, Assess and then Do covers three items — changing materials, substances or components, changing the design, and changing the intended use (including any adjustment of indication statements); placing on the market is suspended while the assessment determines whether the change is a variation or a new device.

The practical decision for any change is therefore whether existing stock may continue to ship: only the first category allows sale to continue immediately, the second requires a filed application first, and the third halts sale pending assessment.

2. Legal basis

3. Expert insights

Insight 1: the names of the three categories state directly whether the device can keep selling — the most practical test.

Do and tell means act and then report — goods are not seized; Tell and Do means report before acting — no placing on the market without an initial acceptance number; Tell, Assess and then Do means report, await assessment, and only then act — placing on the market is suspended first. When a change arises, the first task is to determine which column it falls into, because that decision directly controls whether existing stock can continue to ship.

Insight 2: major and non-major labelling changes are officially defined, and both require reissuance of the licence.

Section 2 defines a major labelling change as a change that may need to be stated in the device certificate and that requires the registration licence to be reissued, so the initial number of the acceptance documents must be obtained; a non-major labelling change concerns the shape or content of internal and external package labelling but does not need to be certified in the device certificate, yet the registration licence still must be reissued and the initial number of the acceptance documents obtained. In short, the licence must be reissued whether or not the change is major — the difference lies only in whether it appears on the certificate.

Insight 3: among the ten Tell and Do items, adding a non-reference-country origin carries an extra condition.

Item 2 covers transferring the manufacturing site (manufacturing plant / actual manufacturer), adding a country of origin or adding a manufacturing site where the legal manufacturer remains the same: where a non-reference-country origin is added, a free sale certificate from a reference country must be submitted. This bears directly on manufacturers from the Chinese mainland — adding China as a country of origin still requires a reference-country FSC.

Insight 4: the three Tell, Assess and then Do items are the gateway for new device determinations.

The treatment of the third category is to suspend placing on the market and then assess whether the change falls under the variation rules or should be regarded as a new device, warranting a new registration dossier accordingly. Such a change can therefore convert directly into a fresh registration. Companies should run an internal new-device risk assessment before initiating changes of this kind.

Insight 5: vigilance obligations during variations are tiered by classification, with separate undertakings.

Section 6.2 sets out several layers: (1) cases requiring assessment by the Central Administration for Pharmacovigilance — where AIMD, Class III and Class IIb devices undergo addition, deletion or change of codes, sterilisation method, packaging or shelf life; (2) cases requiring the manufacturer’s device safety undertaking — where devices of all classifications undergo a shelf life change (extension or reduction) or addition, deletion or cancellation of codes, packaging or sterilisation method; (3) the applicant must undertake that a device vigilance system has been established and that its activities and requirements are followed up; (4) the applicant must undertake to report any regulatory measures related to device safety (incidents, recalls, FSN, FSCA) occurring globally or in Egypt.

Insight 6: variation and registration applications for the same licence may not run in parallel.

Section 10: for the same registration licence, applications may not be submitted simultaneously to the Device Variation Department and the Device Registration Department (imported, evaluated and locally manufactured devices); otherwise the corresponding rules apply. This prevents companies from opening a new registration while a variation is pending. (Practical estimate: the concrete consequences follow the current text of the guideline.)

Insight 7: registration licence data may never be altered by hand.

Section 10 also states that any deletion or alteration of the registration licence data is prohibited, on pain of cancellation, consistent with Section 11.5 of GL.CAMD.002. Every data change must go through the variation procedure, never through edits on the certificate.

4. Practical recommendations

1. Build a change-to-category mapping table: map recurring changes to Do and tell, Tell and Do, or Tell, Assess and then Do.
2. Determine first whether stock can keep shipping: Do and tell allows continuation; the other two require a filed application first.
3. Prepare a reference-country FSC in parallel when adding a non-reference-country origin.
4. Run an internal new-device assessment before the three Tell, Assess changes.
5. Prepare vigilance undertakings alongside the variation: check by classification whether the Central Administration for Pharmacovigilance must be involved; shelf life, code, packaging and sterilisation changes require the manufacturer safety undertaking for all classifications.
6. Never submit variation and registration applications in parallel for the same licence.
7. Never edit registration licence data directly.

5. Verification checklist

• □ The change has been mapped to one of the three categories (the 3 / 10 / 3 item lists)
• □ It has been confirmed whether stock may continue to ship (Do and tell yes; the others require a filed application)
• □ The labelling change has been classified as major or non-major (both require licence reissuance)
• □ Where a non-reference-country origin is added, a reference-country FSC is ready
• □ The three Tell, Assess changes have been assessed for whether they constitute a new device
• □ Vigilance undertakings are prepared by classification (AIMD / III / IIb and all-classification situations)
• □ No variation and registration applications have been submitted in parallel for the same licence

Regulatory information verified as of 29 October 2026. The three variation categories described here follow the current text of Section 6.1 of EDREX: GL.CAMD.003 Version 3; the labelling change definitions follow Section 2.

• Local resource in Egypt: GRZAN assists manufacturers from the Chinese mainland and other overseas markets in engaging the Egyptian Drug Authority (EDA) for medical device registration, import approvals and variation applications, including design of the registration applicant scheme (importing company, local factory or scientific office), preparation for scientific committee evaluation, analysis of pathways for obtaining free sale certificates from reference countries, Arabic localisation of labels and instructions for use, and setup of vigilance systems and periodic reporting.
• Service capabilities: product attribute determination and risk classification (devices Class I–III / IVD Class A–D), registration and re-registration, applicability assessment of system registration and bundled registration, three-category variation determination, import approvals and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; info@grzanglobal.com; website www.grzan.cn.