EUROPE: Updated MDCG Guideline on Medical Device Nomenclature
Last February 2024, the Medical Device Coordination Group (MDCG) updated the MDCG 2024-2 Procedures for the updates of the European Medical [...]
23 02 2024
23 02 2024
23 02 2024
23 02 2024
EUROPE: Proposed Extension for IVD Devices
On January 23, 2024, the European Commission proposed to extend the transition period provided for in Regulation (EU) 2017/746 for in [...]
23 02 2024
23 02 2024
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 current [...]
12 02 2024
12 02 2024
Medical Devices Regulatory Affairs: legal aspects of the profession
12 February 2024 The profession related to the development and management of regulatory activities in the field of Medical Devices [...]
18 01 2024
18 01 2024
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 market [...]
18 01 2024
18 01 2024
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
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 [...]
