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 information and the timeline restarts upon resubmission of missing documents. 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.
Annual Renewal and Maintenance Fees
Registered devices require annual renewal fees to maintain active status in DAPI. Annual renewal fees are typically lower than initial registration fees and must be paid to keep the device authorised for market distribution. Failure to pay annual renewal fees may result in automatic market suspension. Current annual fee amounts should be verified on the Swissmedic website as they are subject to change.
Official Sources
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).