韓國 KFDA 申請流程和提供的資料

latitude

广东安规检测
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此帖為韓國 KFDA 申請流程和提供的資料
本人還在了解如何申請中
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1. General Information

* [' r' ?. {6 p3 E, r1) Manufacture Certificate (Free Sales Certificate) and ISO13485 : in case of USA, CFG.  

1 ~& w' O% ~, N0 Z! W5 b2) Manuals: Op manual, SVC Manual, Pre-installation Manual etc.   
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3) IEC Test Report : 60601-1, 60601-2 etc.  
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1 S# ~8 F- t5 \  w* a4) Performance Test Report, Final Test Report etc. .  

1 D" L# X* ]6 s  Y. M! z6 v1 Y8 k5) Data sheet  

5 @3 B" P2 @9 J* d5 y$ y6) Catalog  
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2 I4 Z4 o. ^' Z6 u: j- r7) Part List  

" [5 v/ w& ]- r9 ]8) Software Validation Report  
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2. below contents should be commented
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+ a1 O) Q: P* s( D/ g6 ?" PA.      Raw materials, Specification of each components (ISO, IEC ASTM etc),  Model name of each components  
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B.      External appearance photos, internal structure, sizes, weight  

6 h/ r# {( i3 L0 oC.      Block diagram of system, Circuit diagram of power supply, Protection degree of electrical shock;  
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- K. Q0 V+ N  f4 i! l2 WD.      Manufacturing methods or flow chart;  

$ L% j1 V  t. U4 r( j1 u) yE.      Specification of the system  
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) v4 {: `2 j) x* G7 gF.       Effectiveness, purpose of use, intended use;  

0 ~' x4 Z1 K1 QG.      Instructions for use;  

1 q0 Z& U' b; g# j1 n/ gH.      Precautions in use;  

I.          Storage methods;  

J.        Information on origin, discovery and background of development (reference, articles)  

K.      Information on determination of structure and physicochemical and biological properties (in case of concerned)  
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* L( r9 x* ~9 N  L$ L1 `. aL.       Stability data - Toxicity data (for only human contact material)  

* [6 C1 r  ~, z3 N3 d, EM.     Sterilization method, condition, Deterioration test etc(in case of concerned)

N.      Clinical study report Foreign clinical studies may be accepted in lieu of local trials. KFDA requires that such studies be conducted according to Good Clinical Practices (GCP). KFDA's preference is a final report of a clinical study published by a reputable professional journal listed on the Science Citation Index. However, KFDA will review unpublished study reports to determine acceptability, depending on GCP compliance and the reputation of the research organization involved.

fan_aaron

楼主还有更具体的东西吗，比如他们怎么分类的？谢谢！！

aitel336412

是哈，楼主看了后能不能联系下我。。有个产品想问下相关申请

latitude

引用第2楼aitel336412于2008-04-10 20:20发表的  :
是哈，楼主看了后能不能联系下我。。有个产品想问下相关申请

+ V. M. m7 R4 Z: Q7 ?. y您可以把問題PO上來, 論壇的人都可以一起討論

往事如烟

KFDA是南韩的食品级测试,咋和电气安全部分扯上了.