Regulatory Terms Starting With T

3 terms in the T index.

• Technology Transfer (Tech Transfer)

  Technology transfer is the transfer of product and process knowledge between development and manufacturing, or between manufacturing sites, so the receiving site can reproduce the process and consistently achieve product realisation.

• TGA (Therapeutic Goods Administration)

  TGA is Australia's national regulator of therapeutic goods, applying the Therapeutic Goods Act 1989 to decide which medicines, biologicals and medical devices may enter the Australian Register of Therapeutic Goods and be supplied lawfully.

• Traditional 510(k)

  A Traditional 510(k) is the default premarket notification format, in which the submitter argues substantial equivalence by presenting and discussing each supporting test on its own terms rather than relying on a standard or a prior clearance.