Tag: FDA Medical Device clinical Regulations

Guidance on Premarket Submission for Device Software Functions

November 12, 2021
Medical Device

The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software...

FDA Medical Device clinical Regulations, fda submission guidance, guidance document pertain to device software functions, Guidance on premarket submission, Medical Device, software design specification medical device, software in a medical device

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

November 5, 2021
Medical Device

EUROPE1. 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...

EU Medical Device clinical Requirements, Europe Regulatory Updates, FDA Medical Device clinical Regulations, medical device labeling requirements, Medical Devices, Regulatory Updates, USA Regulatory Updates

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

September 30, 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...

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