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你看醫療器械定議,寫的很清楚啦.8 A2 L. T% U# t5 n9 g8 u# S$ N
any instrument, apparatus, appliance, material or other Article, whether used alone or in0 N2 z7 a% a4 j( t& p+ D- {: J# C
combination, including the software necessary for its proper application intended by the0 M" @; v" d. ^$ y, ^0 X* Z4 y, E* ]% C
MANUFACTURER to be used for human beings for the purpose of: u* [9 q* Q, G3 H
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
( G! ~! ?: D& x7 b9 G$ C5 e- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
( I5 j0 g1 \* U- investigation, replacement or modification of the anatomy or of a physiological process,
# E: g0 i8 `9 Y' T$ G2 b" Q- control of conception, N9 S; [ u3 A! @3 S
and which does not achieve its principal intended action in or on the human body by
5 `# A! k: \+ ^pharmacological, immunological or metabolic means, but which may be assisted in its8 ]$ H1 M/ N- T. r6 ^+ W, z- t
function by such means. |
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