Mar 30, 2020
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019...
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Jan 28, 2020
North America
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issues guidance dedicated to premarket notification submissions for arthroscopy pump tubing sets intended for multiple patient use. Definition of Arthroscopy Pump...
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Jan 15, 2020
North America
The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Medical Devices for Percutaneous Coronary Intervention The scope of the guidance released by...
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Jan 7, 2020
Asia
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of provisions and cover numerous aspects related to the...
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Sep 25, 2019
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
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