Stability Studies and Climatic Zone IVa Requirements in Egypt

1. Key takeaways

Egypt’s stability study requirements are built from three rules. The first is a condition rule: because Egypt belongs to climatic zone IVa, studies must be conducted at 30 °C ±2 and 65 ± 5% relative humidity. The second is a type rule: devices undergoing re-registration must submit a real time stability study. The third is a trigger rule: whenever the packaging material or the packaging size changes, a new stability study containing only packaging verification must be submitted together with a reassessment of biological risk, evaluated by the stability specialized scientific committee. Taken together, the three rules mean that the stability dossier is not a one-time registration attachment but a living obligation: it is keyed to the Egyptian climate, refreshed at re-registration, and re-opened by any packaging change during the licence life.

2. Legal basis

3. Expert insights

Insight 1: climatic zone IVa is a geographic-climatic hard constraint that cannot be replaced by origin-country conditions.

Sub-item i of the Third item states plainly that the Arab Republic of Egypt belongs to climatic zone IVa, and that stability studies must therefore be conducted at 30 °C ±2 and RH 65 ± 5%. A study completed under temperate conditions (for example 25 °C / RH 60%) is not directly accepted in Egypt; at best it serves as supporting data alongside a properly conditioned study.

Insight 2: the temperature statement on the label and the study evidence are bound together.

Sub-items ii and iii of the Third item require the inner label to carry the symbol indicating a maximum storage temperature of 30 °C, or an explicit statement that the temperature upper limit is 30 °C; and if the manufacturer wishes to mark both an upper and a lower temperature limit, stability evidence for the device across that temperature range must be provided. The freedom to state a range is real, but its price is additional evidence.

Insight 3: execution of the storage conditions is followed up continuously by the inspection authority.

Sub-item iv of the Third item: the manufacturer must store devices under the conditions stated on the inner label and the registration licence, with storage conditions followed up by the Central Administration of Pharmaceutical Institutions Inspection. The conditions fixed by the stability study therefore extend into distribution and warehousing — this is not a one-time registration document.

Insight 4: the four stability trigger rules at re-registration can be used in reverse as design guidance.

Section 10 provides for locally manufactured devices: where no change of packaging raw material has occurred and a real time stability study was submitted at first registration or during the validity of the registration licence, the stability committee is not involved again; where none was submitted, it is evaluated at re-registration; where raw materials changed, the biocompatibility study must be re-evaluated by the stability scientific committee; where the sterilization method changed, a new stability study containing only sterilization verification plus a biological risk reassessment is submitted; where the packaging material or size changed, a new stability study containing only packaging verification plus a biological risk reassessment is submitted. Read together, the four rules define exactly which changes invalidate the stability file.

Insight 5: the study can be outsourced, but the accreditation scope must cover the tests performed.

The Fourth item: where a company cannot conduct the stability study or part of the tests itself, it may commission an accredited entity, submitting that entity’s qualification/accreditation certificate issued under ISO/IEC 17025 and proving that its accreditation scope covers the tests performed; the results remain the responsibility of the manufacturing enterprise. The mapping between accreditation scope and test items is the audit focus.

Insight 6: the stability documents have their own timeline and checklist.

The Action Steps of Section 6: documents are submitted per the Annex 5 checklist through MeDevice; the file is accepted when every checklist item is met; the evaluation period is 10 working days; feedback is given within 5 working days after deficiency correction; once complete, the file goes to the committee. This timeline runs independently of the main registration flow’s 20 working days and should be scheduled separately.

Insight 7: one category of devices can skip the stability study and the biocompatibility report.

The note under Annex 1, item 7(D): locally manufactured devices that have transactions in a reference country do not need to submit biocompatibility test reports and stability studies at registration or re-registration. This aligns with the EDA circular of April 16, 2026 (local factories holding CE exempted from stability studies and biocompatibility reports) and continues the localization policy line.

4. Practical recommendations

1. Design the study for 30 °C ±2 and RH 65 ± 5%: never substitute origin-country climatic conditions.
2. Label the inner packaging at a 30 °C upper limit: if an upper and lower range is wanted, add range stability evidence first.
3. Start the real time stability study at first registration: accumulate data for re-registration years ahead.
4. Maintain a change-to-stability mapping table: raw material, sterilization method, packaging material/size and shelf life/storage conditions each map to different reassessment requirements.
5. Verify the ISO/IEC 17025 accreditation scope before outsourcing any laboratory work.
6. Schedule stability documents separately: Annex 5 checklist, 10 working days evaluation, 5 working days correction feedback.
7. Assess localization exemption applicability: reference-country transactions or CE-holding local factories may be exempt.

5. Verification checklist

• □ Study conditions meet climatic zone IVa (30 °C ±2, RH 65 ± 5%)
• □ Inner label marked with the 30 °C upper limit or an equivalent statement
• □ Re-registration projects: real time stability study prepared
• □ Packaging material/size change projects: new stability study with packaging verification only + biological risk reassessment
• □ Outsourced laboratory: ISO/IEC 17025 certificate and proof of accreditation scope complete
• □ Stability documents submitted per Annex 5, tracked against the 10 / 5 working-day milestones
• □ Exemption applicability assessed under reference-country transactions or the 2026-04-16 CE circular

Regulatory information verified as of October 29, 2026, per the current text of Sections 6 and 10 of EDREX: GL.CAMD.002 Version 2.

• Local resources in Egypt: GRZAN supports manufacturers from the Chinese mainland and overseas in dealing with the Egyptian Drug Authority (EDA) on medical device registration, import approval and change applications, including registration applicant scheme design (import company / local factory / scientific office), scientific committee evaluation preparation, reference-country free sale certificate route argumentation, Arabic labelling and IFU localization, and vigilance system and periodic reporting set-up.
• Service capabilities: product attribute and risk classification (device Class I–III / IVD Class A–D), registration and re-registration, system and bundled registration applicability, three-category change determination, import approval and the annual import plan, vigilance reports and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.