News

On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) published on its official website the Regulation of Class [...]

Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers [...]

Last October 2023, the Medical Device Coordination Group (MDCG) approved the MDCG 2023-4 Medical Device Software (MDSW) - Hardware combinations [...]

On October 2, 2023, the FDA  published an update to the Electronic Submission Template for Medical Device 510(k) Submissionsguidance: Guidance for [...]

On September 11 2023, the European Commission published on its official website the Cybersecurity of Artificial Intelligence in the AI Act, [...]

On September 29, 2023, the Swiss Federal Council amended the Medical Devices Ordinance to improve the safety of products not intended [...]

On August 11, 2023, the Food and Drug Administration (FDA) updated the Off-The-Shelf Software Use in Medical Devices guideline about Off-The-Shelf [...]

On August 9, 2023, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican governmental body in charge of [...]

Even in Saudi Arabia as of September 1, 2023, manufacturers must implement unique device identification (UDI) requirements for placing Class B, [...]

Last July, the State Service of Ukraine on Medicines and Drugs Control (SMDC) announced that the extension period in the manner [...]