Blog Category: Medical Device

Medical Devices – Asia Regulatory Updates Roundup, Oct 2022

November 3, 2022
Medical Device

INDIA (CDSCO) Extension of last date for filing statutory forms prescribed under DPCO, 2013-reg As several representations requesting for extension of last date for filing statutory Forms- III,...

Medical Device – Regulatory & Product Intelligence

November 2, 2022
Medical Device

The Medical Device industry is one of the largest industries in the healthcare sector, with significant growth in the last few years. The industry is undergoing continuous transformation to comply...

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...

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

Medical Device Patient Information Leaflets and Implant Cards

December 24, 2021
Medical Device

From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs)...

mdr implant card requirements, Patient information card, patient information leaflet mdr