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medical devices

China Exempts More High-Risk Medical Devices from Clinical Trials

In an apparent effort to increase access to China’s huge medical device market by...

FDA Issues Updated Guidance on Addressing Medical Device Changes

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

New Handbook Helps Medical Devices Sector Improve its Quality Management System

New Handbook Helps Medical Devices Sector Improve its Quality Management System

Changes to China’s Medical Device Classification May Require New Registrations

A recently published medical device classification catalog issued by the China Food and Drug...

Moisture-Triggered Physically Transient Device that has Tunable Degradation Under the Presence of Moisture

Devices that can physically disappear in a controlled manner are a growing (and increasingly important) type of electronics.
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IEC Releases 2nd Edition of IEC 80601-2-59:2017 for Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC 80601-2-59:2017

FDA Establishes Pre-Market Approval Pilot Program

As part of its effort to streamline the approval process for high-risk medical devices,...

FDA User Fees for Medical Device Applications Slated to Increase

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has published an updated list of consensus...

CFDA May Require Chinese Translation of Foreign Medical Device Applications

The China Food and Drug Administration (CFDA) is reportedly considering a new regulation that...
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