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你看醫療器械定議,寫的很清楚啦.
2 ]8 ?6 g5 t6 x& L# H( }any instrument, apparatus, appliance, material or other Article, whether used alone or in/ ^5 M3 A- O* y# w* t2 k; g
combination, including the software necessary for its proper application intended by the
& L: C4 a3 y) Q/ D1 ?4 zMANUFACTURER to be used for human beings for the purpose of:7 ]+ g ^1 o+ e( T
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
2 H5 r5 U! l6 l( |* [& p' i- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,' _5 X- j! }# H) \% ]
- investigation, replacement or modification of the anatomy or of a physiological process,
3 _: `7 s# ]/ O- Y# s; E- control of conception,# x1 l! F0 D8 l3 h5 e( a! v
and which does not achieve its principal intended action in or on the human body by
8 p$ R7 j* O5 a$ R% x! ~pharmacological, immunological or metabolic means, but which may be assisted in its+ v' v5 f4 D/ X4 D" T5 n
function by such means. |
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