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FDA attestation program reachs his to ask
From;    Author:Stand originally

1.FDA applies for flow

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1.1. enterprise is registered

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A) enterprise registers application form

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B)FDA affirms, issue company series order;

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1.2. product is registered

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1.2.1Product of medical apparatus and instruments divides 3 kinds with safe risk level:

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A)1 kind medical apparatus and instruments lists a control

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B)2 kind market admittance is approbated (namely 510 (K) approbate)

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C)3 kind the approval before PMA enters town

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1.2.2Entrust a representative

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" FDA is registered entrust an agreement with the bulletin " (legal person delegate signs, build company official seal) net of XBi China advisory division
1.2.3Provide a data

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A) legal entity business charter

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Certificate of code of B) career legal person, the commonalty card that register (Xerox builds company official seal) net of XBi China advisory divisionThe aptitude proof inside C) period of efficacy or manufacturing licence certificate (Xerox builds company official seal) net of XBi China advisory divisionD) " FDA registers application form " (in, english each one, build company official seal) net of XBi China advisory divisionE)FDA is new the other file that increases a requirement to refer (if have) .
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