France: ANSM updates Guidelines and Forms for a Scientific Opinion for a Medical Device incorporating a Medicinal Substance

2023-03-29T15:54:00+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, [...]

FRANCE: ANSM offers practical solution to manage clinical trials amid the crisis

2024-02-26T11:01:22+00:00March 20th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The ANSM, in conjunction with the DGS and the DGOS, offers practical solutions for implementing the necessary adaptations for clinical trials in progress in the current situation. The solutions proposed by the authorities have been established in order to [...]

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