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

¹ Any per­son pla­cing a med­ic­al device on the mar­ket must be able to prove that it has been sub­mit­ted to the pre­scribed pro­ced­ures for as­sess­ing con­form­ity.

² The Fed­er­al Coun­cil shall reg­u­late the pre­scribed pro­ced­ures for as­sess­ing con­form­ity. In par­tic­u­lar it shall lay down:

a.

the types of pro­ced­ures;

b.

the med­ic­al devices for which an au­thor­ity for as­sess­ing con­form­ity must be en­lis­ted;

c.

the doc­u­ments re­quired and the length of time for which they should be archived.

³ It may:

a.

re­quire clin­ic­al tri­als for cer­tain med­ic­al devices, which will form an in­teg­ral part of the proof of con­form­ity;

b.

per­mit ex­emp­tions from the con­form­ity as­sess­ment for cer­tain med­ic­al devices or med­ic­al device groups.¹¹²