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Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

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China – Notice on registration of medical device master files (No. 2 of 2021)

On March 5, 2021, the State Food and Drug Administration of China issued an announcement on the Registration of Medical Device Master Files. The relevant matters that facilitate the owner of the master...

FDA Medical Device clinical Regulations, Food and Drug Administration of China, medical device labeling requirements, medical device master files, medical device registration information system, Notice on registration of a medical device

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Color Additive Petitions

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

color additive, color additive petitions, Regulatory requirements for chemical, Regulatory requirements for technological data, Statutory Requirements Regulatory intelligence software, technological data in color additive petitions

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