Sample Import Rules for Medical Devices in Egypt

1. Key takeaways

Egypt sorts sample imports by purpose into four categories, each with its own quantity caps and certificate requirements: ① samples for evaluation or research — sterile and non-sterile alike are limited to one piece per size or type, and the invoice quantity must not exceed 10 pieces; ② samples for scientific evaluation submitted to the scientific committee — one piece per type, with proof that the import is genuinely required for scientific evaluation, and complete quality certificates by classification; ③ samples sent to the faculty of engineering for analysis to be presented to the specialized scientific committee — 3 pieces per type; ④ samples for promotion (advertising) — only scientific offices have the right to import them, and they must be printed as advertising samples, not for sale. Because the same physical product can enter Egypt through four different doors with four different rulebooks, choosing the wrong door is one of the most common self-inflicted delays in the Egyptian market.

2. Legal basis

3. Expert insights

Insight 1: sterile and non-sterile samples follow different certificate-exemption logics.

Under item 1: sterile samples — one piece per size or type may be imported (invoice quantity not exceeding 10 pieces), certificates per classification must be submitted (Annex X), import of samples of the same item for the same manufacturer is allowed only once, and the company is exempt from all quality certificates except the DoC and CE certificate; a different treatment applies if it is shown that the product exists in non-sterile or demonstration form and is therefore exempt from quality certificates. Non-sterile samples — again one piece per size or type (invoice quantity not exceeding 10 pieces), with all quality certificates waived and the declaration of conformity deemed sufficient, but the company must undertake that, if an actual purchase follows, it will comply with all quality certificate requirements.

Insight 2: one piece per type, up to 10 pieces per invoice — a sample batch can therefore cover at most 10 configurations.

This cap directly determines how many physical evaluations a company can perform before registration. For consumables with many sizes — sutures, catheters and the like — the sizes for the first sample batch must be chosen with care, because the unused headroom cannot be recovered within the same approval.

Insight 3: scientific evaluation samples are, counter-intuitively, the category with the strictest certificate requirements.

Item 2: samples for scientific evaluation submitted to the scientific committee must not exceed one piece per type per invoice, the company must prove that the import is necessary for scientific evaluation, and complete quality certificates must be submitted by item classification. The contrast with item 1 — where certificates are largely waived — is deliberate: the more formal the purpose, the more complete the certificates.

Insight 4: faculty-of-engineering analysis samples are fixed at 3 pieces per type, with a supplement addressing the no-agent case.

Item 3: samples sent to the faculty of engineering for analysis to be presented to the specialized scientific committee must have an invoice quantity of 3 pieces per type; where there is no contract with the manufacturer (supplier), the company must submit a letter from the factory stating that it has no agent in Egypt; quality certificates are provided by classification. The faculty of engineering here refers to designated analysis institutions mentioned in the guideline, such as the Faculty of Engineering of Ain Shams University.

Insight 5: promotion samples are an exclusive right of the scientific office.

Item 4: only scientific offices may import samples for advertising and market-promotion purposes; the samples must be printed as advertising samples, not for sale; verification is performed by the Central Administration of Pharmaceutical Institutions Inspection; and the importing scientific office must provide all quality certificates by device classification. Whether samples may be used for promotion is thus tied directly to the identity of the importing entity.

Insight 6: sample import and registration samples are two different channels.

Annex 1, item 7(L) of GL.CAMD.002 requires samples of the product to be registered as part of the registration dossier, while the four categories described here belong to the sample import channel under import approval. In practice companies usually walk both paths: first bring the physical units into Egypt through the sample import channel, then submit them as dossier samples.

Insight 7: batch-by-batch testing of sterile devices is a separate, parallel obligation.

Elsewhere in the import approval chapter the guideline provides that certain device categories must have samples drawn each year from arrival batches and sent for analysis to an accredited institution, while other categories must draw samples from the first shipment. Surgical devices have their own rule: up to 3 samples drawn from 5 different categories, with the sampling method set by the general administration as a condition for allowing trade. These are post-market batch testing obligations, distinct from pre-registration sample import. (Practical estimate: the applicable categories and sampling frequencies follow the current guideline annexes.)

4. Practical recommendations

1. Select the sample channel by purpose: evaluation/research, scientific evaluation, engineering analysis and promotion have different requirements — never mix them.
2. Keep the first sample batch within 10 configurations: the invoice quantity cap binds.
3. Assemble complete certificates by classification for scientific evaluation samples: this channel has no certificate waiver.
4. Fix engineering analysis samples at 3 pieces per type, adding the factory no-agent letter where no contract exists.
5. Route promotion samples through a scientific office, printed as advertising samples, not for sale.
6. Prepare registration dossier samples separately, in parallel with the import approval channel.
7. Build an annual plan for batch sampling and testing of arrival lots.

5. Verification checklist

• □ Sample import channel determined by the four purpose categories
• □ Evaluation/research samples: 1 piece per size or type, invoice quantity ≤10 pieces
• □ Sterile samples: the once-only limit per item per manufacturer confirmed
• □ Non-sterile samples: company undertaking letter prepared (full compliance with quality certificates upon actual purchase)
• □ Scientific evaluation samples: 1 piece per type + necessity proof + complete quality certificates
• □ Engineering analysis samples: 3 pieces per type; factory no-agent letter where no contract exists
• □ Promotion samples imported by a scientific office and printed as advertising samples, not for sale

Regulatory information verified as of October 29, 2026, per the current text of Section 8, Instructions for importing samples, of EDREX: GL.CAMD.007 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.