But the TGA application was dependant on the ISO accreditation and audit etc. No idea on how the "overseas" devices have made it through TGA, in what appears to have been an easy process.
What would be good from the company is a statement of inventory and what sales volume (without any reference to any particular market) they can carry once the leash is off.
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But the TGA application was dependant on the ISO accreditation...
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