When the Content of the Mandatory Standard Quoted in the Technical Requirements of Registered Medical Device (IVD Reagent) Products Changes, under What Circumstances No Need to Going Through the Registration Change?

If new mandatory standards are issued and implemented within the validity period of the registration certificate of medical devices (in vitro diagnostic reagents), and the items specified in the registration certificate and its attachments of registered products are not changed, that is, they meet the new mandatory standards, including the following two situations:

I.There are applicable mandatory standards for declared products

The form of mandatory standards quoted in product technical requirements is “direct reference to specific contents of mandatory standard terms”, “standard number” or “standard number + year number”.

II.There are no applicable mandatory standards for the declared products

The terms of a mandatory standard are referenced and quoted in the product technical requirements. If the mandatory standard is updated, the standard number and / or year number are changed, and the terms of the mandatory standard referenced and quoted in the product technical requirements are not changed; or the contents of mandatory standard clauses referenced and quoted in the product technical requirements have changed, but the product technical requirements still refer to and quote the contents of mandatory standard clauses before updating.

In the above two cases, the product technical requirements will not change or only the referenced standard number and / or year number will be updated without change registration.

According to the in vitro diagnostic reagents managed by medical devices, if the renewal of national standards is involved, refer to the above requirements.

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