Swiss Medical Device Regulations

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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

26.05.2021. On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance …

Regulation of medical devices - Swissmedic

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

Medical devices are attributed to various risk categories that require varying assessment procedures. The visible result of a compliance assessment is the so-called CE label, which …

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 …

New medical devices regulations - Swissmedic

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/neue-eu-verordnungen-mdr-ivdr.html

On 5 April 2017, the two new EU Regulations on medical devices were adopted by the European Parliament. The new Regulations entered into force on 26 May 2017 and shall …

Regulation | Swiss Medtech

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

ReguLation. Relevant for medical technology is the Swiss law on medical devices, namely the Federal Law on Medicinal Products and Medical Devices (Law on …

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 …

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 …

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’s New Regulations on CE-Marked Medical …

https://meritoem.com/switzerland-regulations/

The new regulations also require a Swiss Importer label on all Class III/IIb + Active Implantable medical devices starting January 1, 2022. The Swiss importer information …