As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – RDM : quelles responsabilités pour les différents opérateurs économiques ?

Alors que les sociétés des sciences de la vie continuent à déchiffrer et mettre en œuvre les exigences du nouveau règlement UE 2017/745 sur les...
Tout ce qu’il faut savoir sur les Biosimilaires

Europe – L’importance du niveau de preuve des données cliniques dans le RDM

Dans son article 61 (point 1), le Règlement UE 2017/745 énonce de façon laconique : « Le fabricant précise et justifie le niveau de...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA releases new fee schedule and announces reform delays

Australia’s Therapeutic Goods Administration (TGA) published its new fee schedule for the upcoming year and announced delays to a series of regulatory reforms. 2020-21 fee...

USA – Impact of COVID-19 emergency on US FDA interactions with medical device manufacturers

The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – Guidance : Review and Update of Device Establishment Inspection Processes and Standards

FDA is issuing this guidance to comply with section 702(b)(2) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA...
New guidance on biologics affects authorized generics

USA – UDI : Policy Regarding Compliance Dates for Class I and Unclassified Devices...

FDA's unique device identification system is designed to adequately identify devices through distribution and use. Its requirements were designed to be phased in over...

USA – FDA : Guidance Documents – Recently Issued

Recently Issued Guidance Documents...

Europe – MDCG 2018-3 Rev.1 (June 2020) Guidance on UDI for systems and procedure...

This guidance should be read in conjunction with the Guidance on "Basic UDI-DI and changes to UDI-DI"1 and the Guidance on "UDI database. Definitions, descriptions and...

USA – FDA issues final guidance on inspections of medical device establishments

The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March...

USA – Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency...

This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement...

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