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Jul 17, 20232 min read

USFDA Guidance: Qualification of Medical Device Development Tools

Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical...

May 21, 20231 min read

Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)

Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...

May 13, 20231 min read

EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...

Apr 29, 20232 min read

MHRA Guidance: Registration & Regulating Medical Devices in UK

Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...

Mar 27, 20231 min read

UK MHRA: Guidance on Register Medical Devices to place on the Market

Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...

May 24, 20221 min read

Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group

On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...