Switzerland: Fees for Class I Medical Devices

Producers of class I (including class Im and Is) medical devices, custom devices and system and procedure packs must pay a fee of CHF300 (US$305) per notification to the Swiss competent authority, Swissmedic, prior to bringing the device into the market in Switzerland.

The new fee applies only to products notified to Swissmedic after January 1, 2019.

These products must be notified by a Swiss-based organization (manufacturer or authorized representative) to Swissmedic on first being introduced into Switzerland, or into a contracting state (EU, EFTA and Turkey) for the first time. You get the revised Swissmedic fees ordinance here (see annex 2  ̶  Gebühren für Medizinprodukte):

 

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