Market access

Market access for medical devices

Manufacturers or importers may only place medical devices on the market when the applicable conformity assessment procedure has been successfully completed. This legal requirement also applies to medical devices that are given away free of charge, rented or used directly on patients. Certain medical devices are associated with a duty to notify the Swiss Agency for Therapeutic Products.

Notification for placing a medical device on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213): Change as of 1 Jan. 2019

Advance notice: Fee for the notification for placing a medical device on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213) 

01.11.2018

The Ordinance of the Swiss Agency for Therapeutic Products on its fees (GebV-Swissmedic, SR 812.214.5, to date: Ordinance on Fees Levied by the Swiss Agency for Therapeutic Products (HGebV)) was approved by the Federal Council on 21 September 2018 and takes effect on 1 January 2019. According to the revised Ordinance, notifications for placing medical devices on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213) will be subject to a fee (CHF 300.- per notification) as of 1 January 2019.