News

On October 14, 2021 the European Commission published a proposal to postpone the IVDR (EU) 2017/746 Regulation full application deadline (May 26, 2022) regarding In Vitro Diagnostic Medical Devices. Following significant delays ...

On October 26, 2021, the US Food and Drug Administration (FDA) Centre for Devices and Radiological Health (CDRH) published the guidance document for fiscal year 2022 (FY2022) and the CDRH ...

Saudi Food and Drug Authority (SFDA) – Regulatory Authority of Medical Devices market in Saudi Arabia – aims to increase patients’ safety by optimizing devices traceability. As a consequence of ...

At the beginning of October 2021 in the EUDAMED database section of the European Commission website, two new modules have been published: “UDI/devices registration” and “Notified Bodies and certificates”. “UDI/ devices ...

At the beginning of October 2021, Medical Device Coordination Group (MDCG) published the fundamental guideline MDCG 2021-24 “Guidance on classification of medical devices” on Medical Devices classification. MDCG 2021-24 on classification ...

On September, 15th 2021, the Australian Therapeutic Goods Administration (TGA) published on their website the updated table with an essential principles list for Medical Devices. The table consists of a useful ...