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Clinical trial requirements for IVD China CFDA Approval

For Class III  IVD clinical trial:

  1. The clinical trial will be performed in at least 3 AAA class local hospitals who has CFDA qualification. 

  2. CFDA requires at least 1,140 tests cases, including 1050 serum specimens and 90 plasma specimens (if applicable for Plasma)  for each IVD reagent, and with not-less-than 30% positive ratio or 300 positive results. 

  3. Need  Randomized, parallel controlled, multi-center study 

  4. IVD Reagents required (each reagent): ˇ°12 months shelf lifeˇ±

  5. for test group ¨C 3,000 tests (exclusion of standards and controls tests); 

  6. Comparison assay  cases is required with same quantity.

 

For Class II  IVD clinical trial (new product, no CFDA approved equivalent IVD is available in China):

 

Though it is class II device, due to they would be considered as New Products in China and no CFDA approved equivalent product is available in China, CFDA requires to perform the clinical trial similar to Class III requirements.

  1. The clinical trial will be performed in at least 3 AAA-class local hospitals who has CFDA qualification.

  2.  CFDA requires at least 1,140 tests, including 1050 serum specimens and 90 plasma specimens (if applicable for Plasma), for each reagent and with not-less-than 30% positive ratio or 300 positive results.

  3.  Need  Randomized, parallel controlled, multi-center study

  4.  IVD Reagents required (each reagent): ˇ°12 months shelf lifeˇ±

  5.  for test group ¨C 3,000 tests (exclusion of standards and controls tests);

  6.  Comparison assay  cases  is required with same quantity.

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For Class II  IVD clinical trial:(CFDA approved equivalent IVD is available in China)

  1. The clinical trial will be performed in at least 2 AAA-class local hospitals who has CFDA qualification.

  2. CFDA requires at least 250 tests, including 220 serum specimens and 30 plasma specimens(if applicable for Plasma), for each reagent and with not-less-than 30% positive ratio.

  3. Need  Randomized, parallel controlled, multi-center study

  4.  IVD Reagents required (each reagent): ˇ°12 months shelf lifeˇ±

  5.  for test group ¨C 500 tests (exclusion of standards and controls tests);

  6.  Comparison assay  cases is required with same quantity.

 

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