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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 (EU) system of compliance assessment and …
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
- These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance (MedDO) and a new Ordinance on Clinical Trials …
Regulation | Swiss Medtech
- https://www.swiss-medtech.ch/en/regulation
- Medical Device Regulation in Switzerland. Switzerland has had a national medical device regulation since 1996. The partial revision of the Law on Therapeutic …
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 …
Medical devices - Swissmedic
- https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html
- Notification of medical devices Notification of IVDs Notification of devitalised human tissue Expired certificates - MDCG 2022-18 Exemption authorisations Import, sale and …
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
- However, from the Date of Application of the EU Medical Devices Regulation (MDR) on May 26, 2021, this is no longer the case; Switzerland will become a …
Medical Device registration in Switzerland - Thema Med
- https://www.thema-med.com/en/medical-device-registration-switzerland/
- Procedure: Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and having not reached an institutional agreement, Switzerland is …
Homepage [www.swissmedic.ch]
- https://www.swissmedic.ch/swissmedic/en/home.html
- New medical devices regulations Information concerning the new EU-Regulations as well as their implementation in Switzerland. Regulation of medical devices New regulations …
Switzerland Medical Device Registration - Swissmedic …
- https://arazygroup.com/medical-device-registration-switzerland/
- Medical Device Regulations and Classification in Switzerland. REGULATORY AUTHORITY :Medical device licensing in Switzerland is governed by Swissmedic, the …
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