{"id":3516,"date":"2017-07-25T10:39:01","date_gmt":"2017-07-25T08:39:01","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=3516\/"},"modified":"2024-02-28T11:56:04","modified_gmt":"2024-02-28T10:56:04","slug":"medical-device-registration-egypt","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-egypt\/","title":{"rendered":"Medical Device Registration in Egypt"},"content":{"rendered":"
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Regulatory Authority<\/b><\/h5>\n

Egyptian Drug Authority (EDA) and Drug Policy and Planning Centre (DPPC)<\/p>\n

Classification<\/strong><\/h5>\n

class I (low risk), class IIa and IIb (medium risk) and class III (high risk)<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of March 2024. Legislative and regulatory provisions are subject to change and updating by the Regulatory Authorities of the State to which they relate. This being said, the writer disclaims all liability concerning any lack of topicality and\/or accuracy of information that may have occurred at the same time as or following the publication of this page. Disclaimer<\/strong><\/a><\/em><\/span><\/div><\/div><\/div><\/div>

To bring a medical device into Egypt, it must be registered with the Regulatory Authority. Class I, IIa and IIb devices must be registered with the Drug Policy and Planning Centre (DPPC) and Class III devices with the Egyptian Drug Authority (EDA).<\/p>\n

To market a medical device in Egypt, a registration file must be submitted, which is assigned a temporary code that should include the declaration of conformity, the free sale certificate from the country of origin, the ISO 13485 certificate and the EC certificate (strongly recommended) if already obtained.<\/p>\n

The EDA is generally only involved in the registration process of class III medical devices. In this case, the importer must submit to the EDA a letter from the manufacturer and the importer itself declaring that they comply with the EDA’s vigilance regulations, reporting any recalls, warnings or field safety corrective actions related to other countries, and communicating any incidents that occurred in Egypt.<\/p>\n

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Applicant<\/span><\/h3>\n

The foreign manufacturer must appoint a local authorised representative (ERH) responsible for importing the devices in Egypt and in charge of post-market surveillance activities in the territory.<\/p>\n

Timeframes and Costs<\/span><\/h3>\n

Reviewing the technical file may take up to 30 working days and the manufacturer is given 60 working days to respond to any comments raised by the EDA\/DPPC. The DPPC, upon completion of the verification, issues an import approval, while the EDA issues a marketing authorisation and its verification activities can take up to 18 months.<\/p>\n

Validity<\/span><\/h3>\n

Import licences are valid for ten years.<\/p>\n

Documentation Language <\/span>and <\/span>Labelling <\/span><\/h3>\n

The labelling (labels and instructions for use) for medical devices for professional use can be made available in English while that for devices for domestic use in Arabic.<\/p>\n

Useful Information<\/span><\/h3>\n

The EDA facilitates the entry into Egypt of medical devices already marketed in Europe, and therefore EC marked, and in countries such as the USA, Canada, Australia and Japan.<\/p>\n

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n