Medical Device Association Switzerland

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The voice of the Swiss medical technology industry

https://www.swiss-medtech.ch/en

EU Position Paper MDCG 2022-18 describes a transitional solution for dealing with certification gaps. Confirmations («written communications») from the responsible …

Medical devices - Swissmedic

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

Obligations for authorised representatives, importers and distributors. Swiss Single Registration Number (CHRN) Swiss authorised representative (CH-REP) Unique Device …

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 …

Switzerland to recognize US FDA cleared …

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 …

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: 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, …

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 …

AdvaMed - Advanced Medical Technology …

https://www.advamed.org/

MedTechVets helps veterans find meaningful employment in the medical technology industry. Sponsored by AdvaMed, this nonprofit bridges the gap for veterans by providing …

Home - AMDR

https://amdr.org/

AMDR represents regulated, commercial reprocessing, promotes reprocessing as an important healthcare strategy that helps hospitals and healthcare providers increase …

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