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

Art. 48 Dispensing and use

1 For the pro­tec­tion of health, the Fed­er­al Coun­cil may, for cer­tain med­ic­al devices:

a.
make pro­vi­sion that they can only be dis­pensed on a med­ic­al pre­scrip­tion;
b.
lay down the ne­ces­sary tech­nic­al and op­er­a­tion­al con­di­tions or a man­dat­ory no­ti­fic­a­tion for their dis­pens­ing and use;
c.
at­tach to the dis­pens­ing of products the con­di­tion that the devices con­cerned must be trace­able between their man­u­fac­ture and their use and vice versa.

2 Art­icle 26 ap­plies by ana­logy to med­ic­al devices.119

119 In­ser­ted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).