Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)

¹ If re­quired for the pro­tec­tion of health, the Fed­er­al Coun­cil may re­strict or pro­hib­it the im­port or ex­port of cer­tain med­ic­al devices.

² If an­oth­er state re­quests ex­port cer­ti­fic­ates and at­test­a­tions for med­ic­al devices which are to be im­por­ted, the Agency may, on re­quest, is­sue these doc­u­ments to the man­u­fac­turer or to the au­thor­ised rep­res­ent­at­ive with a re­gistered of­fice in Switzer­land.¹¹⁶

³ Any­one ex­port­ing a med­ic­al device to a state with which Switzer­land has con­cluded an agree­ment un­der in­ter­na­tion­al law for the mu­tu­al re­cog­ni­tion of con­form­ity as­sess­ments and pro­ced­ures for med­ic­al devices must be able to demon­strate that the fun­da­ment­al re­quire­ments re­ferred to in Art­icle 45 para­graph 2 are ful­filled.¹¹⁷