IVD Registration Unit

According to the CFDA regulation issued on July 30th 2014 In Vitro Diagnostic (IVD) Reagent Registration Management Method (the 5th status), in vitro diagnostic (IVD) reagents included in the Medical devices catalog also have to be registered in China. And during the registration process, the registration unit’s determination is a very important part. The registration unit stands for all the products that can be included in the single registration application.

IVD registration units function:

It can finish the same registration unit products application one time in one registration certificate.
It can add the relevant models and specification through the alteration application.
It can merge or split.

One registration unit should be one kind of regent or one kind of regent kit. The same registration unit can include different packing types.

Calibration product and quality control products can send the same registration application with the cooperating in vitro diagnostic (IVD) reagents, but they can also be registered separately.

One kind of reagent kit means all the used regents or partial reagents composed reagent kits that used for the one certain test or same category tests.

One kind of reagent represents all the reagent components existed as a separate form in the regent kit.

The different permutation and combination reagent kits that for the joint inspection can be the same registration unit. There is special situation that the single item in the test reaction systems relatively independent and not mixed.

Related articles:

Medical Device and IVD Registration in China（Update in 2016）

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