UDI

zhaizhai

请教各位老师，定制式义齿在FDA需要满足UDI的要求吗？我看定制式义齿在FDA属于定制器械，不需要UDI哦，不知道有没有理解错

Neuro_psycho

现在全部需要了，DDL记得是20年中，最低级别的也开始需要了。

Compliance Date        Requirements
September 24, 2020        Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2018        The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).

zhaizhai

captain_ye 发表于 2022-04-02 09:15
现在全部需要了，DDL记得是20年中，最低级别的也开始需要了。

Compliance Date        Requirements
September 24, 2020        Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2018        The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).

我是未分类的，也需要吗？如果要的话，直接去GUDID里面录入数据是吧

来自安卓APP客户端

小金库

感谢分享。