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Food and Drug Administration (FDA) Japan Medical Devices

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

Ropes & Gray LLP on

Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

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