Technical File Requirements for Medical Device Registration in Egypt

1. Key takeaways

The way the Egyptian technical file is organized rests on a premise that is easy to overlook: the entire content must be presented on the legal manufacturer’s letterhead, stamped by the manufacturer and signed by the legal manufacturer, and must state the device trade name. Only then does the item sequence matter — twelve items, A through L: the composition certificate (with the approved supplier list, PVC codes and the grade list), the sketch diagram, the product analysis certificate (physical, chemical and biological), a copy of the stability study, the sterilization certificate, the certificate for packaging materials and units per pack, a textual description of the inner and outer label data, the master label together with the embedded leaflet and its original artwork, the catalog, the shelf-life certificate, the original registration licence when re-registering, and samples of the product to be registered. A neutral, unbranded PDF compilation — the format most companies naturally produce — does not satisfy the first condition and will be treated as not submitted.

2. Legal basis

3. Expert insights

Insight 1: letterhead, stamp and trade name are the three elements of the technical file; missing any one means the file is deemed not submitted.

The lead-in of Annex 1, item 7 states the three conditions together: the technical file content must be presented on the legal manufacturer’s letterhead, stamped and signed by the legal manufacturer, and must contain the device trade name. Companies commonly compile the technical file as a neutral typeset PDF; in Egypt this is returned for redo. The three conditions are formal rather than scientific, which makes them cheap to satisfy and expensive to ignore — a full resubmission cycle is the penalty for a cover-page decision.

Insight 2: the composition certificate is broken down to PVC codes and grades, a level of detail rarely seen in comparable markets.

Item A requires the (R.M composition) composition certificate, accompanied by the approved supplier list and the list of PVC codes and grades. Egypt therefore asks not only what the product is made of, but also which PVC code and which grade is used. Consumables containing PVC — infusion sets, catheters, blood bags and similar products — must prepare this item explicitly, and suppliers should be able to issue the code and grade documentation on demand.

Insight 3: the analysis certificate can be completed by a declaration, but the declaration has a designated basis.

Item C requires the product analysis certificate (physical, chemical and biological), accompanied by a letter stating that the methods used comply with the manufacturing standard and that the manufacturer takes responsibility. The guideline further specifies that the analysis certificate in the dossier is sufficient provided the manufacturing enterprise issues a letter stating that the methods used comply with the manufacturing standard and the manufacturer takes responsibility under Circular No. 12 of 2012. This converts the burden of proving method validation into a manufacturer’s declaration anchored to that circular.

Insight 4: stability studies and biocompatibility have an explicit exemption for one category of devices.

The note under item D states that 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 reads together with the first submission scenario of Section 6 (local manufacture without a reference-country FSC and without a 510(k)): local devices with a reference-country FSC are exempt, while those without one must go before the stability committee.

Insight 5: storage conditions stated in the stability study must land on the label, and compliance is followed up by inspection.

Item D makes clear that the manufacturer must state on the device label the storage conditions described in the stability study, with conformity followed up by the Central Administration of Pharmaceutical Institutions Inspection. Together with the climatic zone IVa requirements of Section 6 and the special storage precautions field of the labelling guideline, this closes the loop between the study, the label and post-market inspection.

Insight 6: the labelling package is a set of three documents.

Item H requires the master label, the embedded inner leaflet stamped by the manufacturer, and the original artwork of the inner and outer packaging, sealed, stamped and signed by the manufacturer. Item G separately requires a textual description of the inner and outer label data. One set describes content in words, the other presents the physical artwork; neither substitutes for the other, and both must match the approved trade name and storage statements.

Insight 7: Class I non-sterile devices carry their own additional item.

The closing sentence of Annex 1 requires that Class I non-sterile devices additionally provide the compliance with essential requirements and harmonized standards check list. This is the substitute evidence attached to the simplified route for low-risk devices, and it should be assembled against the same essential requirements and harmonized standards tables used in other jurisdictions to avoid rework.

4. Practical recommendations

1. Move the whole technical file onto the legal manufacturer’s letterhead: consistent throughout, stamped and signed page by page.
2. Add the PVC codes and grades list for PVC-containing products, submitted alongside the approved supplier list.
3. Pair the analysis certificate with the methodology declaration letter, citing Circular No. 12 of 2012.
4. Determine whether the stability and biocompatibility exemption applies: local manufacture plus reference-country transactions.
5. Align label storage conditions with the stability study and anticipate the inspection authority’s follow-up.
6. Assemble the labelling trio in one pass: master label, stamped inner leaflet, sealed and signed artwork.
7. Attach the essential requirements and harmonized standards check list for Class I non-sterile devices.

5. Verification checklist

• □ Technical file entirely on legal manufacturer letterhead, stamped and signed, stating the trade name
• □ Item A: composition certificate + approved supplier list + PVC codes and grades list
• □ Item B: sketch diagram; item C: analysis certificate + methodology declaration letter
• □ Item D: copy of stability study (exemption applicability determined)
• □ Item E: sterilization certificate; item F: packaging material and units-per-pack certificate
• □ Items G/H: textual description of label data + master label + stamped inner leaflet + sealed signed artwork
• □ Items I/J/K/L: catalog, shelf-life certificate (with storage conditions), original registration licence (re-registration), product samples
• □ Class I non-sterile: essential requirements and harmonized standards check list attached

Regulatory information verified as of October 29, 2026, per the current text of items 6 and 7 of Annex 1 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.