The Therapeutic Goods Administration (TGA) has indicated a new online form is to be lodged when applying for consent to import, supply, or export a medical device that does not comply with the Essential Principles for Safety and Performance (Essential Principles).
Ordinarily, importers, suppliers, and exporters must comply with the Essential Principles found here. However, depending on the circumstances, applicants may seek consent for non-compliance from the Secretary of the Department of Health by completing the appropriate form and paying the relevant fees.
The new application form can be found in the TGA Business Services portal. The TGA has also produced a guidance document concerning the new form, available for download here. Further, a recent explanatory presentation by TGA representative Kathryn Fuller can be downloaded here.
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