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Whether does medical apparatus and instruments need to be registered afresh afte
From;    Author:Stand originally
Recently, bureau of inspect of some city medicine is opposite when some medicine company is checked, those who discover its reserve is medical executive standard of product of absorbent gauze designation is YY 0331-2002, manufacturing date is March 2008, the product was registered 2005, register card to be inside period of efficacy, active standard ought to be YY 0331-2006. According to " medical apparatus and instruments registers administrative measure " the regulation of relevant provision, product standard changes, must register afresh; Without what register and sell, by without register certificate processing. Bureau of this medicine inspect plans to carry out administration to punish to some medicine company then, but should carry out after all why to plant punish? Concerned personnel offerred a variety of opinions.

A kind of opinion thinks to should be pressed " special provision " executive punishment. Because this kind of behavior was disobeyed " the special provision that the State Council manages about strengthening the product safety such as food to supervise " (say below " special provision " ) the 3rd; Disobeyed " medical apparatus and instruments registers administrative measure " the 34th, according to the 48th regulation, should depend on " medical apparatus and instruments monitors regulation " by manage without register book product punishment. In the State Council " special provision " after carrying out, according to special law excel common law principle, press to its " special provision " the 3rd the 2nd section provision fines 100 thousand yuan.

The 2nd kind of opinion thinks industry sell on commission has certain fault without the product that registers in time afresh, but harm sex is not big, also did not cause undesirable consequence, can press manage the lowermost limit punishment that does not have the product that registers card, confiscate illegal earning namely, fine 5000 yuan.

The 3rd kind of opinion thinks to should not carry out punishment. Reason is the product registers card to be inside period of efficacy, the product inside period of efficacy should be maintained for legal product.

Analysis

Be aimed at afore-mentioned circumstances, according to " medical apparatus and instruments registers administrative measure " , " special provision " with national bureau " fulfil about carrying out < the special provision that the State Council manages about strengthening the product safety such as food to supervise > executive opinion " , opinion of the first kind of punishment does not have a problem apparently; As to the 2nd kind of opinion, because violate a clue lighter, did not cause undesirable consequence, according to " administration sanctions a method " the 27th, can carry out to opposite person light or reduce punishment, so the surface looks use the 2nd kind of punishment more rational, also had accorded with punish the principle that comparative. And actual condition is not such.
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