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Get the latest global medical device regulatory news, insights from our experts and more.
The Food and Drug Administration has extended its remote inspection policy for pharmaceutical, medical device and other healthcare product manufacturers as the COVID-19 public health emergency persists.
New guidance from the US Food and Drug Administration explains a phased transition plan for medical devices currently covered by agency enforcement policies devised to address the COVID-19 public health emergency.
A second Polish Notified Body, CeCert, has been designated under the European In-Vitro Diagnostic Medical Devices Directive (IVDD).
US FDA publishes new guidance on timelines and related requirements for emergency use authorization (EUA) terminations for medical devices and IVDs following COVID-19 emergency resolution. Learn more at Emergo by UL.
Swiss regulators develop importation plan for medical devices
The European medical devices regulation (MDR) requires manufacturers to establish clinical development plans (CDP). Learn more about EU MDR requirements at Emergo by UL.
US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.
Canadian regulators explain reporting content, timeframes and related elements of new regulations coming in March 2022 to better manage medical device supply shortages.
Japanese regulators prepare for full acceptance of MDSAP audit reports for medical device quality management system (QMS) conformity assessments in 2022.
How medical device and drug companies can take full advantage of presubmission consultations with the US Food and Drug Administration regarding HF validation test protocol reviews.
Chinese regulators issue new IVD classification rules based on CFDA and IMDRF efforts, plus requirements for self-testing and self-inspection for medical device registrants
Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022.
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