Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct [...]
Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant guidelines [...]
In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is considering [...]
On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested only [...]
The SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs) announced a one-year postponement [...]
The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to check [...]
Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical [...]
The Medical Device Coordination Group (MDCG) on 24 March 2022 released the updated guidelines on the Summary of Safety and Clinical [...]
In just over a year, it will be definitively mandatory to affix the UKCA mark on Medical Devices and IVDs to [...]
As is now widely known, as of 26th May 2021, Switzerland became a Third Country for the EU, following Medical Devices [...]
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