IVD Regulations Amended

Laboratories that develop in-house IVDs will be aware of the regulatory framework introduced by the Therapeutic Goods Administration (TGA).

The requirements for Class 4 IVDs were amended in November 2015 with the outcome being that those developed in-house – either de novo or by modifying a commercial IVD – will have to be listed on the ARTG by 1 July 2017.

There are also changes to the framework that will be of significance to in-house IVDs falling under Classes 1-3.

A full description of the changes can be found on the TGA website