Swissmedic Medical Devices

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Medical devices - Swissmedic

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

Medical devices Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic's focus in the area of medical devices is thus on …

Overview medical devices - Swissmedic

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

The new version of the form for notification of devices manufactured and used in healthcare institutions in accordance with Art. 10 of the Ordinance on In Vitro Diagnostic Medical …

swissdamed – Swiss Database on Medical Devices

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

Since the agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA) has not been updated, registration …

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 …

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

Swissmedic is excluded from the working groups on the joint surveillance of new medical devices and does not have access to implementation-related data. By 26 …

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 …

Direct navigation: news, legal matters, contact - Swissmedic

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 …

Swissmedic, Swiss Agency for Therapeutic Products

https://www.swissmedic.ch/swissmedic/en/home/about-us/swissmedic--swiss-agency-for-therapeutic-products.html

Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic …

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/

a) Obligation to register devices and operators. Manufacturers, authorized representatives and importers domiciled in Switzerland must register with Swissmedic once ( MepV …

Nov 2022: Switzerland Votes to Accept …

https://casusconsulting.com/switzerland-votes-to-accept-fda-devices/

November 28, 2022. Today the Swiss Federal Assembly (parliament) voted in favor of accepting medical devices with US FDA marketing authorization in …

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