Dispensing & imports

CE-marked medical devices may be placed on the market in Switzerland. They may be imported into and dispensed in Switzerland. If the devices are intended for issue to the public (i.e. users with no specialist medical knowledge), full product-related information must appear on the packaging and the package leaflet in the three national languages (German, French and Italian).
No authorisation is required to dispense and import medical devices. Dispensing points and importers must comply with the relevant legal provisions and are subject to a duty of care.

Outlets that dispense medical devices to the public (e.g. pharmacies, drug stores, supermarkets, mail-order companies, webshops and vending machines) must satisfy the appropriate operating conditions (e.g. storage conditions) and ensure that professional advice is available. Professional advice extends to medical considerations, provides answers to questions and facilitates dialogue on the intended use of the medical device. Dispensing points and importers are obliged to participate in product surveillance.

Medical devices can be dispensed on a self-serve basis if this is the manufacturer's intention. Outlets that dispense medical devices on a self-serve basis (e.g. supermarkets, webshops) must also comply with the legal; provisions (e.g. concerning operating conditions, professional advice and product surveillance). A dispensing point can set up a medical hotline in three languages to provide professional advice. Further information on the requirement criteria to be observed by dispensing points, on medical devices for the public and on the issuing of medical devices on a self-serve basis can be found here:
In connection with preventive market surveillance, Swissmedic has reminded more than 100 Swiss webshops of their responsibility as regards professional advice, product surveillance, operating prerequisites and documents that the dispensing point must produce for the authorities on request. The letter to webshops can be found here:
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/dispensing---imports.html