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你看醫療器械定議,寫的很清楚啦.
: D: t& u& w' Z$ F% aany instrument, apparatus, appliance, material or other Article, whether used alone or in
3 U" m( m4 p1 o7 dcombination, including the software necessary for its proper application intended by the6 e1 f2 I/ \7 n
MANUFACTURER to be used for human beings for the purpose of:
6 p# Q; H# U' U4 g- diagnosis, prevention, monitoring, treatment or alleviation of disease,
( [4 G, l Q7 B1 e- _- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
0 j& T& g4 h# o. |9 d* U- investigation, replacement or modification of the anatomy or of a physiological process,
( }1 Y" D5 B1 M) c( X- control of conception,+ h/ r! @( K% B$ {- `3 X
and which does not achieve its principal intended action in or on the human body by/ N0 H* K7 P: Q
pharmacological, immunological or metabolic means, but which may be assisted in its
# x% [# A# a" H- P( M. o, Yfunction by such means. |
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