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EC Amends Notified Bodies Designation Procedure

The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...

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MHRA Guidance on Field Safety Notices MHRA

MHRA Guidance on Field Safety Notices

The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...

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Change Control: Ethiopian Guidance for Medical Devices

The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices. The appropriate...

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WHO Notice on COVID-related Issues

The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document...

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