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你看醫療器械定議,寫的很清楚啦.0 R Z: i) s* R6 G
any instrument, apparatus, appliance, material or other Article, whether used alone or in
" t0 k/ K+ w/ \, y" }combination, including the software necessary for its proper application intended by the/ a; g% K& k2 {; a J4 Z7 ~2 C. {
MANUFACTURER to be used for human beings for the purpose of:6 P# k% T; p( l) F3 p
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
/ a+ K0 k" C3 N* s" E& h* B- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,0 e2 Q2 e0 r! W I' J- W# Z4 t) D
- investigation, replacement or modification of the anatomy or of a physiological process,6 w8 U; M6 P1 @7 x. H
- control of conception,* }. f$ z/ A1 \
and which does not achieve its principal intended action in or on the human body by4 s3 I4 a& W; R, o
pharmacological, immunological or metabolic means, but which may be assisted in its' f) \' O+ b+ E2 }4 r
function by such means. |
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