Medical Device Definition under Law No. 151/2019 in Egypt

1. Key takeaways

Egypt defines a medical device in Article 1, definition item 3, of Law No. 151/2019: any instrument, apparatus, medium, machine, or application manufactured by the manufacturing company for the purpose of use on human beings, including implants, laboratory reagents, electronic programs, substances, or other similar or related articles, used alone or in combination for one of seven medical purposes. The definition applies only where the principal intended action is not achieved in or on the human body by pharmacological, immunological, or metabolic means, although such means may assist the function of the device. In structure and wording the definition is highly consistent with the IMDRF and GHTF framework. Three practical consequences follow immediately: in vitro diagnostics fall inside the device category, standalone software falls inside the device category, and every drug-device boundary question turns on the single exclusion clause about principal intended action.

2. Legal basis

3. Expert insights

Insight 1: the seventh purpose in the seven-purpose list settles where IVDs belong.

The seven medical purposes enumerated by the definition are: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation, or compensation of injury or disability; investigation, replacement, modification, or support of anatomical structure or of a physiological or pathological process or state; sustaining or supporting life; control of conception; disinfection of medical devices; and providing information by means of in vitro examination of samples taken from the human body. The seventh purpose places in vitro diagnostic devices squarely within the device category rather than in a separate product class. IVD manufacturers therefore follow the device definition, the device procedures, and the dedicated IVD classification scale, and they should not assume a parallel regulatory track exists.

Insight 2: the rule that the principal intended action is not achieved by pharmacological, immunological, or metabolic means is the only exclusion switch.

This clause matches the IMDRF definition, and its meaning is precise: such means may assist the device, but they must not constitute its principal mode of action. For drug-device combinations and devices incorporating biological materials, the entire boundary determination hinges on identifying what the principal mode of action actually is. The same clause explains why Egypt requires products containing a dosage form within a device to be submitted separately to a dedicated Scientific Committee for evaluation of safety and efficacy and of prescription or non-prescription status. Companies should document the principal mode of analysis explicitly in their regulatory strategy rather than leaving it implicit.

Insight 3: electronic programs are written into the definition, so software-based devices need no separate legal basis.

Because the definition expressly names the electronic program, software as a medical device (SaMD) falls directly within the statutory scope. There is no need to argue whether software counts as a device in Egypt; the legislature has already settled the question. The correct next step is to proceed directly to classification and to evidence preparation, including software lifecycle documentation and a reasoned classification justification, instead of spending resources on a scope argument that the law has already resolved.

Insight 4: disinfection of medical devices is itself one of the enumerated medical purposes.

The sixth purpose brings products intended for disinfecting medical devices into the device category. As a result, a disinfectant product may simultaneously touch definition item 9 of Article 1, which covers disinfectants, and definition item 3, which covers devices. The boundary determination must return to the product’s intended use and intended target: a product whose purpose is to disinfect instruments behaves as a device, while a product acting as a general disinfectant is captured by the disinfectant definition. The distinction should be fixed in the intended-use statement before submission.

Insight 5: definition item 1 on medical technology and definition item 2 on medical products form the overarching framework.

Article 1 first defines medical technology, meaning the application of knowledge and technical skills in pharmaceuticals, radioactive materials, sera, human vaccines, medical devices, and related fields, and then defines medical products, meaning formulations that act through pharmacological, immunological, or metabolic action, before finally defining devices. This ordering shows the legislature’s logic: products acting through pharmacological and similar means are medical products, and everything else within the seven purposes is a device. Understanding that two-tier structure keeps the device definition from being stretched over products that the law deliberately assigns elsewhere.

4. Practical recommendations

1. Compare the product against the seven purposes first: map the intended use clause by clause against the seven statutory purposes; fitting any one of them brings the product into the device scope.
2. Then apply the exclusion switch: determine whether the principal intended action is achieved through pharmacological, immunological, or metabolic means, and for drug-containing or biological-material products prepare a documented mode-of-action rationale.
3. Handle IVDs as devices, not as a separate class: prepare reagents, calibrators, and controls under the device definition and classify them on the A–D IVD scale.
4. File software-based products directly as devices: prepare software lifecycle documentation and the classification rationale from the outset.
5. Route borderline products to the Scientific Committee: for dosage-form products or uncertain modes of action, reserve time in the plan for dedicated Scientific Committee evaluation.

5. Verification checklist

• □ Compared the intended use item by item against the seven purposes of Article 1, definition item 3
• □ Determined whether the principal intended action is achieved through pharmacological, immunological, or metabolic means
• □ Prepared a mode-of-action rationale for drug-containing or biological-material products
• □ Handled IVDs within the device scope and classified them on the A–D scale
• □ Prepared software-based products under the device definition
• □ Reserved Scientific Committee evaluation time for borderline products

Regulatory information verified as of October 29, 2026. The definitions described in this article follow the current official text of Article 1 of Law No. 151/2019; when the law is amended or new definitions are issued, the content must be re-checked.

• Local Egypt support: 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 structure (importing company, local factory, or scientific office), preparation for Scientific Committee evaluation, advisory work on pathways for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the build-out of vigilance systems and periodic reporting.
• Service capabilities: product characterization and risk classification (devices Class I–III and IVDs Class A–D), registration and re-registration, determination of applicability of system registration and group 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.