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


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Art. 47b Quality management 115

1 The man­u­fac­turer must es­tab­lish and main­tain a qual­ity man­age­ment sys­tem which is ap­pro­pri­ate to the risk class and type of med­ic­al device and en­sures com­pli­ance with the re­quire­ments of this Act.

2 The qual­ity man­age­ment sys­tem shall in­clude, in par­tic­u­lar, a risk man­age­ment sys­tem and a post-mar­ket sur­veil­lance sys­tem.

115 In­ser­ted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).

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