Australian medical device and IVD manufacturers must obtain and maintain Therapeutic Goods Administration (TGA) certification in order to manufacture devices in Australia. Initially this process includes a Conformity Assessment Application and audit by the
KD&A can assist you to most effectively demonstrate compliance with TGA requirements
TGA. Ongoing surveillance audits are also completed by the TGA.
KD&A has significant experience with the TGA, and the Conformity Assessment process – we are ready to guide you efficiently through application and audit, to full compliance.
Contact us if you require a custom quote.
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