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MHRA Guidance for Medical Device Manufacturers on Vigilance

October 26, 2022
Medical Device

Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). Once a medical device has been placed on the UK...

Medical Devices–USA/Europe Regulatory Updates Roundup, August 2022

September 27, 2022
Medical Device

EUROPE MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs This document has been endorsed by the Medical Device Coordination...

USA/Canada/UK/EU approved product Labels: Aug 2022

September 27, 2022
Standards

Below are some analytics and counts of Product labels released from Canada, USA, UK and EU. Following 5 charts give the breakdown of these A. Human prescription labels by Country: ...

Color Additive Petitions

September 24, 2022
Standards

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...

Medical Devices – USA/Europe Regulatory Updates round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

January 7, 2022
Standards

There are vast amounts of data being collected on patients, for example, in electronic health records (EHR), and disease and patient registries. Such data are commonly called Real World Data (RWD),...