Case Study 11: Regulatory Strategy, Gap Analysis, Classification and Registration of IVDs Kits in Australia

Company Situation

The Client is a US manufacturer of In Vitro Diagnostic kits used for testing in blood drugs and alcohol levels. It has also a pregnancy test. Client has already registered the IVD kits in several key global markets and was seeking a partner to do the same in Australia. Since the IVDs had to be registered according to TGA’s regulations, it required a holistic strategy right from device classification, to review of technical files and further regulatory submissions.

GRP Solution

GRP has significant experience in handling IVDs of similar categories. GRP did a thorough planning of each steps considering the timelines the client was aiming the launch. GRP provided comprehensive strategic inputs to Client to enable its successful registration in Australia using following methods.

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