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Tag: EFDA

EFDA Guidance on GMP Site Inspection Management: Reports and Administrative Measures

Medical Devices
The new article covers the matters related to the preparation of the reports, GMP quality assurance, administrative measures, and complaint handling procedures.  Table of...

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EFDA Guidance on Medical Device Labeling: Location and Content

Medical Devices
The new article describes in detail certain specific aspects related to the labeling for medical devices intended to be marketed and used in Ethiopia,...

EFDA Guidance on Medical Device Labeling: Overview

Medical Devices
The article provides an overview of the regulatory requirements for medical device labeling introduced in Ethiopia.  Table of ContentsThe Ethiopian Food and Drug Authority...

EFDA Guidelines on Conformity Assessment of Medical Devices: Documentation

Medical Devices

The post EFDA Guidelines on Conformity Assessment of Medical Devices: Documentation appeared first on RegDesk.

EFDA Guidelines on Conformity Assessment: QMS and Post-Market Surveillance

Medical Devices

The post EFDA Guidelines on Conformity Assessment: QMS and Post-Market Surveillance appeared first on RegDesk.

EFDA Guidelines for Marketing Authorization of Medical Devices: Classification and Grouping, Borderline Products

Medical Devices

The post EFDA Guidelines for Marketing Authorization of Medical Devices: Classification and Grouping, Borderline Products appeared first on RegDesk.

EFDA Guidance on Storage and Distribution: Dispatch and Outsourced Activities

Medical Devices

The post EFDA Guidance on Storage and Distribution: Dispatch and Outsourced Activities appeared first on RegDesk.

EFDA Guidance on Storage and Distribution: Personnel, Stock Control, and Other Activities

Medical Devices

The post EFDA Guidance on Storage and Distribution: Personnel, Stock Control, and Other Activities appeared first on RegDesk.

EFDA Guidance on Storage and Distribution: Premises

Medical Devices

The post EFDA Guidance on Storage and Distribution: Premises appeared first on RegDesk.

EFDA Guidance on Good Storage and Distribution Practice: Recalls

Medical Devices

The post EFDA Guidance on Good Storage and Distribution Practice: Recalls appeared first on RegDesk.

EFDA Guidance on Clearance: Importation in Detail

Medical Devices

The post EFDA Guidance on Clearance: Importation in Detail appeared first on RegDesk.

EFDA Guidance on Storage and Distribution: Management Review, Complaints, and Returned Devices

Medical Devices

The post EFDA Guidance on Storage and Distribution: Management Review, Complaints, and Returned Devices appeared first on RegDesk.

EFDA Guidance on Requirements of Medical Devices Clearance: Introduction

Medical Devices

The post EFDA Guidance on Requirements of Medical Devices Clearance: Introduction appeared first on RegDesk.

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