CMDE Q&A|How to Deal with the Changes in the Standards Cited in the Technical Requirements of Registered Device Products?

Q: When the contents of the mandatory standards cited in the technical requirements of registered medical devices (in vitro diagnostic reagents) change, under what circumstances does it not need to go through the change registration？

A.New mandatory standards have been issued and implemented within the validity period of the registration certificate for medical devices (in vitro diagnostic reagents), and the registered products’ registration certificate and its attachments do not change, that is, they meet the new mandatory standards, including the following two situations:

a.The declared product has applicable mandatory standards
Product technical requirements refer to mandatory standards in the form of “directly citing the specific content of mandatory standard clauses”, “standard number” or “standard number + year number”. The mandatory standard is updated, the standard number and/or year number is changed, and the content of the mandatory standard clause referenced in the technical requirements of the product remains unchanged.

b. There are no applicable mandatory standards for the declared product
The terms of a mandatory standard are referenced in the product technical requirements, the mandatory standard is updated, the standard number and / or year number are changed, and the terms of the mandatory standard referenced in the product technical requirements are not changed; Or the contents of the mandatory standard clauses referenced in the product technical requirements are changed, but the product technical requirements still refer to the mandatory standard clauses before the update.

In the above two cases, the technical requirements of the product do not change or only the referenced standard number and/or year number are updated, and no change registration is required.

In the case of in vitro diagnostic reagents for medical device management involving upgrading of national standard products, the above requirements shall be referred to.

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