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Australian TGA Device Approval Applications * Medical Device Submissions * Regulatory Insight
Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.
Comprehensive worlwide regulatory consulting services.
In order to import, manufacture, distribute and sell medical devices in Australia, regulatory approval must first be obtained
from the Therapeutic Goods Administration (TGA) by applying to have the medical device included in the
Australian Register of Therapeutic Goods (ARTG).
Regulatory Insight has assisted several companies to obtain regulatory approval from the TGA.
We would welcome the opportunity to help your company gain TGA approval for your medical devices as well.
FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions
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