Following the US FDA and now the EU Commission’s EUDAMED, Australia’s Therapeutic Goods Administration (TGA) also has...
UDI
UDI Compliance Update
The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to...
FDA UDI Requirements for Convenience Kits
The Unique Device Identification system is used to identify the device throughout its distribution and use on the...
The Unique Device Identification System for Class I and Unclassified Devices
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify...
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