News

April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, modified [...]

On March 6, 2024, the European Commission amended Implementing Decision (EU) 2021/1182 on harmonised standards for single-use medical gloves, biological [...]

Last February 2024, the Medical Device Coordination Group (MDCG) updated the MDCG 2024-2 Procedures for the updates of the European Medical [...]

On January 23, 2024, the European Commission proposed to extend the transition period provided for in Regulation (EU) 2017/746 for in [...]

On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the current [...]

The Egyptian Drug Authority (EDA) announced that, as of January 2 2024, both foreign importers and manufacturers wishing to market [...]

In December 2023, the Brazilian National Health Surveillance Agency  (ANVISA) updated the Regulation Resolução Da Diretoria Colegiada - RDC Nº [...]

Last December, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2023-6, Guidance on demonstration of equivalence for Annex [...]

On November 23, the Therapeutic Good Administration (TGA) published the revision of the Clinical Evidence Guidelines Version 3.2, in which [...]

Last November, the Medical Device Coordination Group (MDCG) approved the revision of the MDCG 2022-11, Notice to manufacturers and notified [...]