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Tag: regdesk medical device

DRAP Guidance on Clinical Trials: Import, Timelines, and Ethical Approval

The new article provides additional details regarding the regulatory requirements for the importation of investigational products, as well as other aspects.  Table of ContentsThe...

Kenyan Guidance on Post-Market Surveillance: Communication

The new article describes in detail certain specific aspects related to post-market surveillance – in particular, the way the authority is going to communicate...

DRAP Guidance on Clinical Trials: Application in Detail

The new article describes in detail the procedure to be followed when applying for permission to conduct clinical trials in Pakistan.  Table of ContentsThe...

Kenyan Guidance on Post-marketing Surveillance: Reporting

The new article describes in detail the regulatory requirements related to reporting incidents with medical devices and other healthcare products. Table of ContentsThe Ministry...

DRAP Guidance on Clinical Trials Applications: Overview

The article provides an overview of Pakistan’s regulatory framework for clinical trials and applications to be submitted by interested parties.  Table of ContentsThe Drug...

NHRA Guidance on Medical Device Importation Approval: Overview

The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices. The document constitutes a draft guidance...

Kenyan Guidance on Post-Marketing Surveillance: Roles and Responsibilities

The new article describes in detail the responsibilities of the parties involved in operations with medical devices in terms of post-marketing surveillance.  Table of...

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