If The Applicable Instruments For The IVD Reagents Have Not Been Approved Yet? Can The IVD Reagents Be Submitted For Registration?

The registrations of IVD reagents and instruments follow different regulations and their applications should be submitted separately. However, the evaluation of the performance of reagents and their applicable instruments is an inseparable verification process. Therefore, when the design of the reagents and instruments has been settled down, the approval order of the reagent and its applicable instrument is not fixed.

It should be noted that, when applying for IVD reagent registration, it should be ensured that the applicable instruments are finalized, and its performance on the specified instruments is fully verified and confirmed.

Only after the IVD reagent and its applicable instruments are all approved for marketing in China, can the reagent be used clinically in China in accordance with the approved instruction.

For gene sequencing reagents using high-throughput sequencing methods, the sequencer should have been approved in China when registration is applied for, or the sequencer and the reagent should apply for registration at the same time. The gene sequencing reagents should not be used on a sequencer for research use only or unapproved in China.