RegDesk Regulatory Roundup -- Medical Device and Pharma

Jan 27, 2023

TGA Guidance on Reclassification of Active Implantable Medical Devices: Overview

The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...

Jan 27, 2023

Canada

Health Canada Guidance on Clinical Evidence: Comparator Devices

The new article highlights the key points related to comparator devices in the context of submitting clinical evidence when applying for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has...

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

Jan 27, 2023

FDA

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

The new article addresses the aspects related to the risk-based approach to human factors engineering information in marketing submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...

FDA Draft Guidance on VMSR Program: Product Code Eligibility

Jan 26, 2023

FDA

FDA Draft Guidance on VMSR Program: Product Code Eligibility

The new article highlights the key points related to specific products eligible for the program, their periodic evaluation, and eligibility requests. Table of Contents The Food and Drug Administration (FDA or the Agency), has published a draft guidance document...

MHRA Guidance on SaMD: Qualification and Concepts

Jan 23, 2023

Europe

MHRA Guidance on SaMD: Qualification and Concepts

The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...

HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body

Jan 16, 2023

Asia

HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body

The article provides an overview of the changes to the applicable classification rules with respect to a specific category of medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products,...

RegDesk Regulatory Roundup

TGA Guidance on Reclassification of Active Implantable Medical Devices: Overview

Health Canada Guidance on Clinical Evidence: Comparator Devices

FDA Draft Guidance on Human Factors Information: Risk-Based Approach

FDA Draft Guidance on VMSR Program: Product Code Eligibility

MHRA Guidance on SaMD: Qualification and Concepts

HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body

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