News


List of recalls



Inhouse News


26.05.2021

New regulations applicable to medical devices as of 26 May 2021

Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU

Warnings and counterfeits



Announcements


18.06.2021

Swiss authorised representative (CH-REP)

Appointment of a Swiss authorised representative

26.05.2021

New regulations applicable to medical devices as of 26 May 2021

Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU

11.05.2021

Field Safety Corrective Actions due to defective sterilisation of medical devices by the company Steril Milano S.r.l.

Information about Europe-wide field safety corrective actions and recalls

09.04.2021

COVID-19 rapid self-tests: Validation, exemptions and dispensing

The Federal Office of Public Health (FOPH) checks the validation of COVID-19 rapid self-tests (also known as SARS-CoV-2 self-tests). These may be dispensed to private individuals only by pharmacies.

18.03.2021

Prior notification of change in the law

Harmonization of the legal provisions for issuing export certificates (FSC) and attestations

Call for Experts



Updated PDF forms


As of 26 May 2021, the existing MedDO is being terminated and the documents relating to the old law are being replaced by new versions on the Swissmedic website. Changes and newly available documents will be communicated continuously. In view of the large number of documents and the short preparation time between the approval and entry into force (one week), delays may occur in individual cases, particularly for the various language versions (not all specification documents will be available in all languages at the same time).

Permanent link of this page
www.swissmedic.ch/md-en

Contact

Swissmedic
Medical devices
Hallerstrasse 7
3012 Berne
Switzerland


Last modification 26.05.2021

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