News

On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing Practice [...]

In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan for [...]

On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union - EUR-Lex (Regulation (EU) [...]

On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of medical [...]

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 [...]