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EUROPE MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 The document has been endorsed by the Medical Device Coordination Group...

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,...

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...

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...

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...