Stability and Biocompatibility Committee Requirements in Egypt

1. Key takeaways

Under Section 6 of EDREX: GL.CAMD.002, Egypt has established a dedicated scientific committee for stability and biocompatibility studies, and four categories of situations require mandatory submission: first, the registration and re-registration of devices that are locally manufactured and have no transactions in any reference country; second, packaging changes or additions, changes or additions of the sterilization method, and changes of storage conditions handled by the change department; third, shelf-life extension (at re-registration or change); fourth, correction of a shelf life made necessary by an erroneous shelf-life certificate submitted by the company. Procedurally, the stability documents are submitted against the checklist of Annex 5, the assessment period is 10 working days, feedback on missing items follows within 5 working days of correction, and the file then goes to the committee.

2. Legal basis

3. Expert insights

Insight one: climatic zone IVa is a substantive obligation, not merely advice on study design.

The Third item of the section provides that, because the Arab Republic of Egypt lies in climatic zone IVa, stability studies must be conducted under storage conditions of 30 °C ± 2 and relative humidity of 65 ± 5%. The inner label must bear the guidance symbol for a maximum storage temperature of 30 °C, or an express statement that the upper temperature limit equals 30 °C. Where the manufacturer wishes to state both an upper and a lower temperature limit, stability evidence for the device across that temperature range must be provided. Furthermore, the device must be stored under the conditions stated on the inner label and the registration license, with follow-up by the Central Administration for Inspection of Pharmaceutical Institutions. This single item binds the label, the study and the storage conditions into one continuous obligation.

Insight two: sample retention for local factories is a continuing obligation, not an obligation at the point of submission.

The First item provides that when a local factory submits a stability study, the samples must be sealed by the Central Administration for Inspection of Pharmaceutical Institutions, stamped by the entity that conducted the study (the factory or an accredited laboratory), and retained at the factory for the validity period of the device registration license, with batch numbers identical to those stated in the stability study. The inspection administration must also provide sealing records and its inspection checklist template applicable to the factory laboratory. The decision applies to stability studies conducted after 2 January 2018. Retention runs across the entire license validity of 10 years, which means the factory must operate a dedicated retained-sample management system for the full life of the license.

Insight three: re-registration requires a real-time stability study; accelerated stability is not sufficient.

The Second item consists of a single sentence: devices submitted for re-registration must present a real-time stability study. Read together with the 10-year validity of the registration license under Section 11.7, this means that the company must begin accumulating real-time stability data at first registration, so that a full dataset is available when the renewal falls due a decade later. Accelerated studies may support interim positions, but they cannot substitute for the real-time dataset at re-registration, and there is no indication in the text of any exception.

Insight four: studies and tests may be outsourced, but responsibility is not, and ISO/IEC 17025 is the gate.

The Fourth and Fifth items provide that where a company cannot itself conduct the stability study or part of the tests, it may entrust them to an accredited entity, but must submit that entity’s qualification or accreditation certificate issued under ISO/IEC 17025 and must demonstrate that the scope of accreditation covers the tests performed; the test results remain the responsibility of the manufacturing enterprise. Biocompatibility studies must likewise be conducted by an accredited entity, with the same requirements. Outsourcing therefore reduces laboratory workload but transfers none of the regulatory accountability, and the scope-of-accreditation check must be documented, not assumed.

Insight five: the sterilization method field appears again here, and it is mandatory.

The Sixth item provides that all studies relating to sensitization and irritation testing must state clearly the sterilization method of the device examined. Together with the sterile-device requirements of Section 4.1 and the sterilization change provisions of the change guide, this forms the third occasion on which the Egyptian authorities interrogate the same field. A study report that omits the sterilization method is defective on its face, whatever the quality of its underlying data.

Insight six: devices imported from a reference country and routed through the change department are exempt from biocompatibility studies.

The Seventh item provides that devices imported from a reference country and submitted to the change department are exempt from submitting biocompatibility studies when they go before the dedicated scientific committee for stability and biocompatibility. The exemption does not extend to locally manufactured devices or to imports from non-reference countries, so it offers no direct benefit to manufacturers from the Chinese mainland; but it explains why reference-country status carries such weight in the Egyptian system, and why establishing a genuine reference-country marketing footprint is strategically valuable.

4. Practical recommendations

1. Assess submission triggers against the four categories: local manufacture without reference-country transactions, packaging or sterilization or storage condition changes, shelf-life extension, and correction of an erroneous shelf-life certificate.
2. Build retained-sample management for local factories: sealing, stamping, identical batch numbers, and retention until the registration license expires (10 years).
3. Plan the real-time stability study well before re-registration: start accumulating data at first registration.
4. Design labels around the 30 °C upper limit: add the guidance symbol or the statement that the upper temperature limit equals 30 °C; upper and lower limits require supporting stability evidence.
5. Check the ISO/IEC 17025 scope before engaging an outsourced laboratory: both the certificate and the scope demonstration are required, without exception.
6. State the sterilization method in every sensitization and irritation study: the field is mandatory and its absence is itself a defect.

5. Verification checklist

• □ It has been determined whether one of the four submission categories is triggered
• □ Stability documents have been submitted against the checklist of Annex 5
• □ The 10-working-day assessment period and the 5-working-day correction feedback period have been scheduled
• □ Study conditions comply with climatic zone IVa (30 °C ± 2, RH 65 ± 5%)
• □ Re-registration projects are covered by a real-time stability study
• □ The ISO/IEC 17025 certificate and scope demonstration of any outsourced laboratory are in place
• □ For local factories, sealing, stamping, identical batch numbers and long-term retention have all been implemented

Legal information verified as of 29 October 2026. The stability and biocompatibility committee rules described in this article follow the current text of Section 6 of EDREX: GL.CAMD.002 Version 2.

• Egypt local resources: 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 arrangement (importing company, local factory or scientific office), preparation for scientific committee assessment, argumentation of routes for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the establishment 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 determination for system registration and bundled 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.