Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee. Medical device manufacturers, clinical teams, and regulatory professionals are urged to take note of the January 23, 2026 deadline to ensure compliance. This update emphasizes transparency and maintains uniform standards for medical device safety and performance.
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What changed?
Swissmedic has rolled out its self-declaration system for the annual oversight fee for 2025. Companies within the Swiss therapeutic market are now responsible for declaring the oversight fees independently instead of relying solely on pre-calculated invoices from the authorities. This aligns with regulatory initiatives promoting greater accountability and operational efficiency.
Who is affected?
The update primarily impacts medical device manufacturers, importers, distributors, and other stakeholders operating in Switzerland. Regulatory and quality assurance teams should prepare to submit accurate self-declarations to avoid fines or delays in compliance processes. Companies dealing in Class I, II, and III devices are all within scope.
How to comply
Declaration process
Medical device stakeholders must submit their fee declaration to Swissmedic before the deadline of January 23, 2026. Forms and guidelines for the self-declaration process are available on the official Swissmedic website. Stakeholders should review their device portfolio, annual revenue, and associated fees to ensure an error-free declaration.
Penalties for late submission
Failure to declare oversight fees within the required timeline could lead to penalties or non-compliance citations. While Swissmedic has not elaborated on specific penalties, regulatory delays are likely if obligations are not met promptly.
Best practices
- Review Swissmedic’s official guidelines and fee structures.
- Ensure your internal compliance teams are aware of the new requirements.
- Cross-check data for accuracy before submitting documentation.
- Leverage Swissmedic’s support channels for any questions or clarifications.
FAQs
Q1: What is the oversight fee?
A: The oversight fee funds Swissmedic’s regulatory activities to ensure public health and safety regarding therapeutic products.
Q2: Does it apply to all medical devices?
A: Yes, the oversight fee applies to all devices registered and marketed in Switzerland, including all device classes.
Q3: Can amendments be made after submission?
A: While Swissmedic allows amendments under specific circumstances, timely and accurate initial submission is recommended to avoid complications.
Conclusion
The shift to self-declaration for oversight fees underscores Swissmedic’s goals of streamlining and enhancing regulatory compliance. Clinical teams, manufacturers, and distributors should treat this as a high-priority task ahead of the January 23, 2026 deadline.
Disclaimer
This information is designed for regulatory professionals working with medical devices. It does not constitute legal or financial advice. Contact Swissmedic or consult a legal expert for clarification on individual cases.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/aufsichtsabgabe-2025.html