Search


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...
Sharan Murugan
Jul 17, 20232 min read
46 views
0 comments


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...
Sharan Murugan
May 21, 20231 min read
175 views
0 comments


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...
Sharan Murugan
May 13, 20231 min read
79 views
0 comments


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...
Sharan Murugan
Apr 29, 20232 min read
64 views
0 comments


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...
Sharan Murugan
Mar 27, 20231 min read
111 views
0 comments


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...
Sharan Murugan
May 24, 20221 min read
18 views
0 comments