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

¹ The man­u­fac­turer must re­gister med­ic­al devices in the in­form­a­tion sys­tem spe­cified in Art­icle 62c or in the European data­base on med­ic­al devices (Eu­damed). It must also en­sure that a unique device iden­ti­fi­er is as­signed to the med­ic­al device.

² The Fed­er­al Coun­cil shall define the mod­al­it­ies for re­gis­tra­tion and for device iden­ti­fic­a­tion. It may provide for ex­emp­tions from the ob­lig­a­tions spe­cified in para­graph 1.

³ It may reg­u­late the ob­lig­a­tions in­cum­bent on the oth­er eco­nom­ic op­er­at­ors con­cerned and on health in­sti­tu­tions in con­nec­tion with re­gis­tra­tion and device iden­ti­fic­a­tion. It may, in par­tic­u­lar, provide for an ob­lig­a­tion to re­cord and store the unique device iden­ti­fi­ers of the devices ac­quired or sup­plied in cer­tain cat­egor­ies.

⁴ The fol­low­ing are deemed to be eco­nom­ic op­er­at­ors:

a.

the man­u­fac­tur­ers;

b.

the per­sons au­thor­ised to rep­res­ent man­u­fac­tur­ers with headquar­ters abroad (au­thor­ised rep­res­ent­at­ives);

c.

the im­port­ers;

d.

the dis­trib­ut­ors;

e.

the nat­ur­al and leg­al per­sons who com­bine med­ic­al devices in or­der to place them on the mar­ket in the form of a sys­tem or a pro­ced­ure pack;

f.

the nat­ur­al and leg­al per­sons who ster­il­ise devices as spe­cified in let­ter e be­fore they are placed on the mar­ket.