RegDesk Regulatory Roundup -- Medical Device and Pharma

Mar 22, 2023

FDA Draft Guidance On Electronic Systems, Records, and Signatures In Clinical Investigations: Overview

The new article describes the aspects related to the use of electronic form in certain aspects associated with clinical trials. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

Mar 22, 2023

Saudi Arabia

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...

FDA Assembler’s Guide to Diagnostic X-Ray Equipment: Overview

Mar 14, 2023

FDA

FDA Assembler’s Guide to Diagnostic X-Ray Equipment: Overview

The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

MDA Guidance on Classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices: Overview

Mar 14, 2023

Asia

MDA Guidance on Classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices: Overview

The document outlines the key points related to the applicable classification requirements for specific types of medical devices. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a...

HSA Guidance on “Dear Healthcare Professional” Letters: Overview

Mar 14, 2023

Asia

HSA Guidance on “Dear Healthcare Professional” Letters: Overview

The article provides an overview of the regulatory requirements related to the content of special communications to be issued by medical device manufacturers in order to inform about the issues associated with the products they are responsible for. Table of Contents...

FDA Guidance on X-Ray Devices and IEC Standards: Enforcement Actinos and Standard Types

Mar 6, 2023

FDA

FDA Guidance on X-Ray Devices and IEC Standards: Enforcement Actinos and Standard Types

The new article addresses the aspects related to enforcement actions the authority may take, and also describes the various types of standards. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

RegDesk Regulatory Roundup

FDA Draft Guidance On Electronic Systems, Records, and Signatures In Clinical Investigations: Overview

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

FDA Assembler’s Guide to Diagnostic X-Ray Equipment: Overview

MDA Guidance on Classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices: Overview

HSA Guidance on “Dear Healthcare Professional” Letters: Overview

FDA Guidance on X-Ray Devices and IEC Standards: Enforcement Actinos and Standard Types

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