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Cantonal Authorities

Overview​

Medical device market access is a federal matter (Swissmedic, federal law). However, healthcare practice and aspects of healthcare facility oversight are regulated at the cantonal (state) level. This creates a layered system where both federal and cantonal authorities have roles relevant to medical devices.

Cantonal Roles Relevant to Medical Devices​

Healthcare facility licensing Cantonal health departments license hospitals, clinics, and medical practices. Facility licensing conditions may indirectly affect how devices are used, stored, and maintained within the facility.

Professional licensing Cantonal authorities license healthcare professionals (physicians, nurses, physiotherapists). Professional licensing conditions may affect which device types can be operated by licensed professionals in that canton.

Hospital exemption oversight While Swissmedic receives the formal notification for the hospital exemption (TPA Art. 9 para. 2(a)), cantonal health authorities may also have a role in overseeing in-house manufactured devices used within healthcare facilities in their jurisdiction.

Radiation protection Under the Radiation Protection Act (SR 814.50), cantonal radiation protection offices (operating under federal delegation) play a role in facility licensing for radiation-emitting medical devices. Facilities using X-ray, nuclear medicine, or radiation therapy equipment require cantonal radiation protection authorisation in addition to MedDO compliance.

Interaction with Swissmedic​

Cantonal authorities can refer market surveillance concerns to Swissmedic. In complex cases (e.g. serious incidents at a cantonal facility), Swissmedic and cantonal health authorities cooperate. Primary medical device enforcement is conducted at the federal level through Swissmedic.

Official Sources​

Disclaimer

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