New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)


Performance studies with IVD

New legal requirements for performance studies with IVDs since 26 May 2022.


Vigilance-News Edition 28

In this edition: COVID-19 immunisation: Modification of the Information for healthcare professionals since authorisation; Myocarditis, thromboembolic events, multiple sclerosis; Persistent headache; Methods of signal detection / ”Observed versus expected” analyses


Out-of-Stock – ONIVYDE pegyliert liposomal 4.3 mg/ml, Konzentrat zur Herstellung einer Infusionsdispersion

Befristete Bewilligung zum Vertrieb in irischer Aufmachung


Out-of-Stock – Clamoxyl IV 2g, Pulver zur Herstellung einer Injektions-/Infusionslösung

Befristete Bewilligung zum Vertrieb in französischer Aufmachung


Spikevax COVID-19 vaccine for children up to 5 years: application for indication extension submitted

Swissmedic is reviewing application from Moderna Switzerland GmbH


Moderna COVID-19 vaccine authorised in Switzerland for children aged 6 to 11 years

Swissmedic approves application for indication extension of Spikevax® for children 6 years and older

In focus


COVID-19 Pandemic

Information on the new coronavirus (SARS-CoV-2)

Vaccines against COVID-19

20 years Swissmedic

Anniversary message from the Director

Happy Birthday Swissmedic

Contact for members of the public

Do you have any questions about a particular medicine or a general question about Swissmedic? We’ll be glad to be of assistance. 

Just send an e-mail to anfragen@swissmedic.ch or use our contact form. Thank you.

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Stay up to date

Reporting undesirable effects and incidents


Medical devices

Swiss Public Assessment Report (SwissPAR)


Public Summary SwissPAR


Illegal medicinal products from the Internet

Find out in this video why you should be careful when buying medicinal products online, and what happens if customs officials discover that a consignment addressed to you contains illegally imported medicinal products.



New medical devices regulations

Information concerning the new EU-Regulations as well as their implementation in Switzerland.


Therapeutic Products Legislation update

The modifications following the ordinary revision of the TPA and its right of enforcement will enter into force on 1 January 2019


What are the tasks of Swissmedic in the area of medical devices?

What is a medical device? How do medical devices come onto the market? How do you recognise a medical device? Based on examples, our videos answer these and a number of other questions.

Medical devices: List of Field Safety Corrective Actions (FSCA) and recalls

Swissmedic monitors all safety measures and recalls for medical devices that are manufactured or marketed in Switzerland.

Swissmedic, Swiss Agency for Therapeutic Products


Swissmedic – for therapeutic products you can trust

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

For further information...