Registration Fees and Timelines

Fee Schedule (Indicative)

Fees are set in the MedDO Fees Ordinance (SR 812.213.1). Always verify current fees on the Swissmedic website.

Registration Type	Indicative Fee Range
Class I notification	CHF 200–500
Class IIa registration	CHF 800–1,500
Class IIb registration	CHF 1,500–3,000
Class III registration	CHF 3,000–6,000+
Significant change notification	CHF 200–1,000

Fees are per product group — device families with the same basic design may qualify for group registration.

Indicative Processing Timelines

Application	Indicative Processing
Class I notification	2–4 weeks
Class IIa registration	6–12 weeks
Class IIb registration	8–16 weeks
Class III registration	12–24 weeks

Incomplete submissions are placed on hold pending additional These timelines apply only to complete submissions with all required documentation. information and the timeline restarts upon resubmission of missing documents. Processing times may be extended if Swissmedic requests clarifications or additional technical information from the applicant.

Official Sources

• MedDO Fees Ordinance (SR 812.213.1)

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.

Class Im, Is, Ir Notification Fees

Notifications for Class I modified devices with Notified Body involvement (Im, Is, Ir) typically incur a fee between CHF 300–800 depending on complexity. These notifications include NB certificate details and require verification of sterility or design modifications but are processed faster than full Class IIa registrations (typically 3–6 weeks).