Localization Roadmap for the Medical Devices Industry

General Administration of Market Authorization

1.2- General Administration of Market Authorization:

2. About The administration:

It is one of the Central Administration of Medical Devices which Issuing Import Approvals of All Types Medical Devices.

1.2.1 The administration of laboratory equipments and kits registration:

About The administration:

It is one of the General Administration of market authorization of central administration of medical devices that Issuing import approvals of laboratory equipment and kits (import approvals for each invoice separately and also annual approvals for diagnostic laboratory kits and non-diagnostic laboratory kits for scientific research), issuing a marketing registration license for imported diagnostic laboratory kits, and issuing a marketing registration license for local diagnostic laboratory kits.

The guideline:

1- Regulatory Rules of Registration and Market authorization of In Vitro Diagnostic Medical Devices

2- Regulatory Guideline of The Procedures and Rules of Obtaining Import Approvals for Laboratory and Diagnostic Equipment and their Imported Accessories

1.2.2 The administration of medical devices registration of low risk:

About The administration:

It is one of the General Administration of market authorization of central administration of medical devices for issuance of import permits approvals for all types of medical devices.

The guideline:

1- Regulatory Guideline of Issuance of Import Approvals of All Types Medical Devices

Location of Central Administration Of Medical Devices:

21stAbd EL Aziz AL Soud, Manial Elrawda, Cairo

https://maps.app.goo.gl/EyYBzwwJjxZhwZzJ7

Tel: 0225354100

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