ITALY: Application of Regulation 607 to Ministerial Database
On October 26, 2023, the Italian Ministry of Health published an article on its official website on the page Banca [...]
15 12 2023
15 12 2023
22 11 2023
22 11 2023
INDIA: Import Licence Now Required for Class C and D Devices
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) published on its official website the Regulation of Class [...]
22 11 2023
22 11 2023
USA: FDA Inspections of Manufacturers Planned as of January 2024
Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which covers inspections [...]
22 11 2023
22 11 2023
EUROPE: MDCG Mdcg Approved the Medical Device Software Guideline in Combination with Hardware
Last October 2023, the Medical Device Coordination Group (MDCG) approved the MDCG 2023-4 Medical Device Software (MDSW) - Hardware combinations [...]
20 10 2023
20 10 2023
USA: 510(K) Submission Only With eSTAR Portal
On October 2, 2023, the FDA published an update to the Electronic Submission Template for Medical Device 510(k) Submissions guidance: Guidance for [...]
20 10 2023
20 10 2023
EUROPE: Cybersecurity for High-Risk Artificial Intelligence Systems
On September 11 2023, the European Commission published on its official website the Cybersecurity of Artificial Intelligence in the AI Act, [...]
20 10 2023
20 10 2023
SWITZERLAND: Regulation of Devices Not Intended for Medical Use
On September 29, 2023, the Swiss Federal Council amended the Medical Devices Ordinance to improve the safety of products not intended [...]
19 09 2023
19 09 2023
USA: Content Submission for OTS Software
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 [...]
19 09 2023
19 09 2023
MEXICO: Modified Change Management Requirements on Registration
On August 9, 2023, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican governmental body in charge of [...]
19 09 2023
19 09 2023
SAUDI ARABIA: As of September 1 Mandatory UDI for Medium and High-Risk Classes
Even in Saudi Arabia as of September 1, 2023, manufacturers must implement unique device identification (UDI) requirements for placing Class B, [...]
