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你看醫療器械定議,寫的很清楚啦.
) q' T, S" I9 z, X+ Cany instrument, apparatus, appliance, material or other Article, whether used alone or in
5 [5 x$ M4 l9 Fcombination, including the software necessary for its proper application intended by the
/ [. M' d% n) c# C/ T& aMANUFACTURER to be used for human beings for the purpose of:
" z# E' N& W/ |0 p* B. a$ e L- z- diagnosis, prevention, monitoring, treatment or alleviation of disease,; v/ w. V. ~5 \' t
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
4 ^, U, d# ~% F% `. r5 J& ?& |- investigation, replacement or modification of the anatomy or of a physiological process,
/ G0 ]- R# _ {, g* v' `- control of conception,' s. M7 g, A& U; b' X$ L& W) o
and which does not achieve its principal intended action in or on the human body by
- m) D+ s3 f. }& Gpharmacological, immunological or metabolic means, but which may be assisted in its1 u4 t2 s: |1 d; H3 b/ {! R
function by such means. |
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