USA: Quality Management System for Medical Devices Will Follow ISO13485
On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the [...]
EGYPT: Changes in Medical Devices Import Conditions
The Egyptian Drug Authority (EDA) announced that, as of January 2 2024, both foreign importers and manufacturers wishing to [...]
BRAZIL: Revision of IVD Device Regulation
In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated the Regulation Resolução Da Diretoria Colegiada - RDC [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
UKRAINE: European Regulation 2023/607 recognised for EC extension
Last July, the State Service of Ukraine on Medicines and Drugs Control (SMDC) announced that the extension period in the [...]
UK: template letter published for MDR extension alignment
On 3 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published on its official website the EU [...]
