Egyptian Drug Authority

 
Services > Inspection > Medical Devices

Medical Device

Our Mission

The department of medical device inspection conducts the following types of inspection on medical devices local manufacturers aiming to insure that they apply GMP regulations:

Initial                                                            
Periodic ( routine inspection)
Unannounced
Special
In addition, the department inspects stores of imported medical devices.


Procedures

Sampling

Samplings are done randomly according to an internal discipline.

Releases

The release of sampled product is issued according to the analytical releases from the National Organization for Drug Release and Research (NODCAR).

Recalls

Recall occurs in case of post-marketing non conformity of certain product.

Market Complaints

Reverse Importing


The department oversees the reverse importing process in case of:
Voluntary recall (from suppliers).
Non-conformity of imported medical devices .


Links :


Work Flow (Local)
Work Flow (imported)
Medical Device Factories Inspection
Medica Device Impotred Agents Inspection
Medical Device Companiew Inspection
Medical Devices Inspection Memorandum for 2013
Medical Devices Inspection Memorandum for 2014
Medical Devices Inspection Memorandum for 2015
Medical Devices Inspection Memorandum for 2016
Medical Devices Inspection Memorandum for 2017


 
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