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Sample requirements for IVD Type test of China CFDA Registration

  • For IVD reagents (each reagent):

1. 3 Lots IVD reagent kits are required, with minimum 400 tests (exclusion of standards and controls tests) in each lot.

2. Extra 200 tests IVD reagents closing to expiration date (in one lot) are required.

3. If client can assign an engineer visit testing center assist the testing then no doubt would speed up the testing.

4. Applicant should ship the testing sample to CFDA testing center.

  • For IVD diagnostic device:

1. 2 IVD diagnostic devices is required.

2. Applicant should assign an engineer visit testing center for operation training or demonstration. Normally 2 days is good enough.

3. Applicant should ship the testing sample to CFDA testing center.


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