Feb 2, 2023

SFDA Guidance on AI- and ML-based Medical Devices: Key Elements of Clinical Evaluation

The new article provides an overview of the regulatory requirements for the clinical evaluation of medical devices based on novel technologies. In particular, the document describes the three main components of clinical evaluation and highlights the most important...

SFDA Guidance on Point of Care Medical Devices: Overview

Feb 2, 2023

Saudi Arabia

SFDA Guidance on Point of Care Medical Devices: Overview

The article provides an overview of the applicable regulatory requirements and highlights the key points associated thereto. Table Of Contents: The Saudi Food and Drug Administration (SDFA), a country’s regulating authority in the sphere of healthcare products, has...

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

Feb 2, 2023

Malaysia

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...

FDA Revised Policy for COVID Tests: Key Points

Feb 2, 2023

FDA

FDA Revised Policy for COVID Tests: Key Points

The new article provides an overview of the revised guidance document and outlines the key points associated thereto. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

Feb 2, 2023

Australia and Oceania

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...

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SFDA Guidance on AI- and ML-based Medical Devices: Key Elements of Clinical Evaluation

SFDA Guidance on Point of Care Medical Devices: Overview

MDA Draft Guidance on Medical Device Certificates: Information and Documentation

FDA Revised Policy for COVID Tests: Key Points

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

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