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你看醫療器械定議,寫的很清楚啦.
* f) [1 }2 b4 P- ^1 h" Q* \any instrument, apparatus, appliance, material or other Article, whether used alone or in
/ d, ]9 J. h* z. \combination, including the software necessary for its proper application intended by the% G" X. i6 n/ f/ e. n2 K
MANUFACTURER to be used for human beings for the purpose of:
# H6 F% A J3 m5 ?- diagnosis, prevention, monitoring, treatment or alleviation of disease,) s5 c+ R0 T: v; q* U4 [
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
) R+ O* Z5 u& l( F, f0 P* D- investigation, replacement or modification of the anatomy or of a physiological process,$ P" P( N. k9 o1 k. r
- control of conception,& A' A; u* e$ E. z2 ^! [; m7 k
and which does not achieve its principal intended action in or on the human body by
) T% i+ I: M! `: e/ {/ w2 Ipharmacological, immunological or metabolic means, but which may be assisted in its
( \8 d) g' A. L5 v; G7 Mfunction by such means. |
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