Tag: FDA Medical Device clinical Regulations

Guidance on Premarket Submission for Device Software Functions

Medical Device

This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD)...

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

Medical Device

EUROPE 1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

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

Medical Device

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...

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