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Medical device Clinical trial exemption list

tofm2

Registered
#1
Hello,

Since CFDA's website upgrade to new NMPA structure, all download links have disappeared. I am searching for the official and latest documents from institutionnal sites: NMPA, CFDA...

  1. catalogue of medical devices exempted from clinical trials (I Know there are 2 of such files, word files)
  2. Regulation on the supervision and administration of medical devices (decree of the state council n° 650)
  3. Measures for the administration of registration of medical devices (decree n°4 of china of china food and drug administration)
Can someone help me in finding them. Simplified Chinese is OK

Best regards.
 
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