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你看醫療器械定議,寫的很清楚啦.9 _% Y* ]5 l: H) y' U4 D
any instrument, apparatus, appliance, material or other Article, whether used alone or in
9 U/ N8 c% P' R G, [) }% ?0 S0 Y* Scombination, including the software necessary for its proper application intended by the4 Z) R/ U4 P5 v: v6 W8 O9 K L+ L
MANUFACTURER to be used for human beings for the purpose of:
, j2 J3 J- p, Q2 b; n I- diagnosis, prevention, monitoring, treatment or alleviation of disease,
9 z8 j9 p4 H& V9 R2 f/ N- ~& t- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
: [& T1 ?" E S, M1 x- investigation, replacement or modification of the anatomy or of a physiological process,
8 ~+ U) T9 t% ]- control of conception,
4 U3 |* K) ~: {" n# }$ r9 s" Xand which does not achieve its principal intended action in or on the human body by
, k# u3 V( `, p1 e/ z, Rpharmacological, immunological or metabolic means, but which may be assisted in its3 ?% w! F/ T/ ~( T* k O0 P
function by such means. |
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