Switzerland Medical Devices

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Medical devices - Swissmedic

https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html

International Medical Device Regulators Forum (IMDRF) Medical devices database Swiss Single Registration Number (CHRN) Unique Device Identifiers (UDI) Clinical trials …

New regulations applicable to medical devices as of 26 …

https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html

Switzerland has adapted its legal framework for medical devices in order to retain the existing equivalence between Swiss and EU medical device legislation. The …

Regulation of medical devices - Swissmedic

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices.html

Basic information on medical devices. Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland follows what is specified for the European Union …

Homepage [www.swissmedic.ch]

https://www.swissmedic.ch/swissmedic/en/home.html

Swissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products …

Switzerland to recognize US FDA cleared medical …

https://www.emergobyul.com/news/swiss-regulators-set-recognize-us-fda-cleared-or-approved-medical-devices

November 30, 2022. By Annette Van Raamsdonk. Swiss legislators have authorized adoption of new laws to recognize medical devices and in vitro diagnostic (IVD) devices that have received US Food …

Switzerland to accept FDA approved medical devices

https://obelis.ch/switzerland-to-accept-fda-approved-medical-devices/

on December 28, 2022 On November 28, 2022, the Swiss Parliament reached a key decision by instructing the Swiss Federal Council to adapt national laws to …

Switzerland: What Manufacturers Should Be Aware Of

https://www.johner-institute.com/articles/regulatory-affairs/and-more/switzerland-what-medical-device-manufacturers-should-now-be-aware-of/

Switzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland. But since May 26, 2021, …

Placing Medical Devices on the Swiss Market After the EU MDR …

https://www.emergobyul.com/news/placing-medical-devices-swiss-market-after-eu-mdr-date-application

Swiss manufacturers will be treated like any other non-EU entities, and non-Swiss manufacturers will have to appoint Swiss Authorized Representatives (ARs) and …

Switzerland sets to accept medical devices with FDA …

https://bioalps.org/switzerland-accepts-medical-devices-with-fda-approval/

Switzerland sets to accept medical devices with FDA approval 29.11.2022 The Federal Council is to adapt national laws so that, in addition to medical devices with an EU certificate / CE mark, medical …

2023 Switzerland Medical Device Registration: Who, When & How

https://casusconsulting.com/services/switzerland/device-registration/

Switzerland Medical Device & IVD Registration Requirements Due to larger political issues, the Switzerland-EU Mutual Recognition Agreement (MRA) has lapsed for medical …

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