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Historically reviews of Class I application were conducted by restricted word reviews which the TGA described as follows: Class I medical devices are included on the ARTG following a self-certification being made online by the sponsor through a computer-generated decision process, we undertake post-market compliance reviews for these devices

Figure 7 Autonomic dysfunction, vasoconstriction, and hypoxia Many ME/CFS patients have a unique cardiovascular situation (58) and changes indicative of autonomic dysfunction (329331)

You should then await authorisation and further instructions

This is often due to inadequate fluid intake