In a surprising turn, the Therapeutic Goods Administration (TGA), Australian regulator of therapeutic goods, has announced the introduction of an application fee for Class I devices. Until now, class I devices entered into the register in Australia have had no application fee, but did have an annual license fee. This has likely permitted some products […]
The Therapeutic Goods Administrator publishes regular notices to industry via it’s website on points considered relevant for the market. A Notice published on June 9 noted that TGA will be looking to increase resourcing with regard to the review of clinical evidence, potentially speeding up applications for High Risk applications requiring application audits.