Tag: medical device labeling requirements

Categorization and Registration Process for Devices in EUDAMED

November 19, 2021
Medical Device

Categorization of Devices Categorization of devices to be registered in EUDAMED include: Regulation Devices – Regulation Devices are defined as medical devices and in vitro diagnostic...

Categorization and Registration Process, Categorization of devices to be registered in EUDAMED, eudamed device registration, medical device labeling requirements, Registration Process for Regulation Devices

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

Medical Device Labeling under FDA

March 23, 2021
Medical Device

Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on food, drugs, medical devices, biologics, cosmetics and even radiation emitting electronic products....

FDA Labeling Requirements, Labeling requirements for Medical Devices, Medical Device Labeling, medical device labeling requirements, medical device labels, Medical device regulatory requirements

Labeling and IFU Compliance Soon to Follow EU MDR Transition

February 22, 2021
OTC

Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helped them in organizing the labeling and instructions for use associated with their medical devices....

EU MDR Transition, General Labeling Requirements under EU, Medical Device Labeling, Medical Device Labeling Regulations, medical device labeling requirements, medical device labels