BRAZIL: Revision of IVD Device Regulation
In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated the Regulation Resolução Da Diretoria Colegiada - RDC Nº [...]
18 01 2024
18 01 2024
18 01 2024
18 01 2024
EUROPE: Published the MDCG Guideline on Products without an Intended Medical Purpose
Last December, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2023-6, Guidance on demonstration of equivalence for Annex [...]
15 12 2023
15 12 2023
AUSTRALIA: Clearer Requirements for Clinical Evaluation
On November 23, the Therapeutic Good Administration (TGA) published the revision of the Clinical Evidence Guidelines Version 3.2, in which [...]
15 12 2023
15 12 2023
EUROPE: Acceleration Needed for EC MDR and IVDR Certifications
Last November, the Medical Device Coordination Group (MDCG) approved the revision of the MDCG 2022-11, Notice to manufacturers and notified [...]
15 12 2023
15 12 2023
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 [...]
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, [...]
