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As your ISO 13485 Certified Swiss Authorized Representative, MedEnvoy helps you meet your regulatory requirements in Switzerland. スイス市場への扉：CH-REPコンプライアンス必須ガイド
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This episode unpacks the essential requirements for placing medical devices on the Swiss market following the lapse of the Swiss Authorized Representative: Role of the CH-REP (2025) Check out The Baby in Yellow HERE: Google Play -
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Since May 26, 2021, the EU MDR became mandatory, and Switzerland introduced the MedDO (Medical Device Ordinance). Kommt es durch den Swiss Representative (CH-REP) zu Versorgunsengpässen? The authorised representative is responsible for the formal and safety-related issues connected with the placing on the market of the device.
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Navegando Suiza: Por Qué su Distribuidor no Debería ser su CH-REP A Swiss Authorized Representative, a "CH-REP", is a person or company in Switzerland who has been given written permission by a manufacturer from another
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本エピソードでは、EUとの相互承認協定（MRA）失効後、スイスが医療機器の「第三国」となったことによる影響を解説します