|
你看醫療器械定議,寫的很清楚啦.
1 D* `& G1 e3 V( S u4 l/ Eany instrument, apparatus, appliance, material or other Article, whether used alone or in! z' j% B2 M9 Z& ^" v
combination, including the software necessary for its proper application intended by the/ k' F' v, R1 V e: x
MANUFACTURER to be used for human beings for the purpose of:
0 i+ t+ U) x- r8 f% m ~: k% S- diagnosis, prevention, monitoring, treatment or alleviation of disease,
$ o9 p4 U$ @& u/ e- ^- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
2 d' W3 {0 l8 x- investigation, replacement or modification of the anatomy or of a physiological process,/ D- p' G8 [% ?. y3 T
- control of conception,
8 f3 ~5 i3 B+ w) J3 e) sand which does not achieve its principal intended action in or on the human body by
4 o! E3 H6 L4 g0 Xpharmacological, immunological or metabolic means, but which may be assisted in its
: F) W/ W; P7 g) x3 u( ffunction by such means. |
|