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  • Regulatory NewsRegulatory News

    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
  • Regulatory NewsRegulatory News

    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...
  • RAPS' LatestRAPS' Latest

    RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law

    RAPS announced today that its RAPS Switzerland Chapter has completed the official registration process as a not-for-profit association under Swiss law. The announcement was made during RAPS’ 2017 Regulatory Convergence conference taking place at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September. While the group has been an official RAPS chapter since 2011, this new status gives it additional l...