Submission requirements for in vitro diagnostic reagent declaration data sheets/labels
Tiempo de liberación:
2023-09-27
The state continues to strengthen the registration management of medical devices, and the requirements for the materials submitted by our applicants are "complete materials and meet the statutory form requirements". Today, let's talk about the submission requirements of the instructions/label materials in the in vitro diagnostic reagent application materials.
According to the 2019-2021 period published by Fujian Province, in the statistics of defective items for the first registration and application data of the second type of in vitro diagnostic reagent products, the problem of product specifications/labels accounted for 34%, occupying the first place in the statistics of defective items.
1. In vitro diagnostic reagent instructions:
In September 2021, the State Drug Administration issued the "Announcement on the Publication of In Vitro Diagnostic Reagent Registration Application Data Requirements and Approval of the Format of Proof Documents" in Annex 4, "In Vitro Diagnostic Reagent Registration Application Data Requirements and Instructions", the requirements for product specifications and labeling samples are as follows:
According to the requirements, the product instructions of in vitro diagnostic reagents need to conform to the "Guidelines for Writing Instructions for In Vitro Diagnostic Reagents". The current guiding principle is the 2014 edition. In this guiding principle, the format of the product instructions for in vitro diagnostic reagents and the writing of various contents are explained in detail, which provides principled guidance and reference for us to write the product instructions for in vitro diagnostic reagents.
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Submission requirements for in vitro diagnostic reagent declaration data sheets/labels
The state continues to strengthen the registration management of medical devices, and the requirements for the materials submitted by our applicants are "complete materials and meet the statutory form requirements". Today, let's talk about the submission requirements of the instructions/label materials in the in vitro diagnostic reagent application materials.
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