CFDA released: The text of the IVD reagent manual has changed!

On August 5, the General Office of the Food and Drug Administration issued a notice on the textual changes in the instructions for in vitro diagnostic reagents. The notices on the textual changes of some in vitro diagnostic reagents are as follows:

1. For the following changes in the “Basic Information” item of the in vitro diagnostic reagent manual, including the registrant of the in vitro diagnostic reagent or the contact information of the manufacturer, the name and contact information of the after-sales service unit, the production license number or the change of the production record number If the contact information of the in vitro diagnostic reagent agent is changed, the registrant shall modify it after the relevant information changes. Among them, the production license number or the production record certificate number shall be revised after the corresponding provincial food and drug supervision and administration department issues the production license or the production record certificate.

2. For the in vitro diagnostic reagent manual " Medical Device Registration Certificate Number / Product Technical Requirements Number" item, after the corresponding food and drug supervision and administration department issues the medical device registration certificate, the registrant shall modify the content of the content.

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