王莉：这个过程确实不容易，但难的不是拿证本身。其实作为二类医疗器械，拿到认证并不算太难，甚至拿到FDA批准也不意味着万事大吉——很多产品拿了FDA也未必卖得出去。
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The civil law codes identify when a defendant is morally responsible for causing unjust damage, such that she is morally liable to compensate her victim, through generally worded legal liability rules such as CC 2043. The common law performs the same function in a more opaque and fragmentary fashion, through its “‘pigeonhole’ system of nominate torts,”33 a motley array of more specific liability rules such as battery, defamation, and negligence. Many of these causes of action (such as battery and defamation) take their names from species of relational moral wrongdoing, just like the pigeonhole causes of action found in the classical Roman law34 from which modern civil law codes largely derive.35 But it is a mistake to infer the character of the law’s moral substance from its outer doctrinal form — to insist, as defenders of the Palsgraf perspective often do, on “taking [tort law’s] structures and doctrines at face value.”36 Tort law’s formal structure should certainly be taken seriously. But that requires taking seriously the complex and unruly relationship between the law’s moral substance and its doctrinal form.37 Like the formulary actions in classical Roman law and the writs of action in medieval English common law, today’s common law torts do not wear their moral commitments on their sleeves.38，更多细节参见华体会官网
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