The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has announced that it now recognizes Singapore’s Health Sciences Authority (HSA) as a comparable overseas regulator. The TGA published Use of Market Authorisation Evidence from Comparable Overseas Regulators/Assessment Bodies for Medical Devices (Including IVDs) to publicize the news.
Prior to this change, manufacturers and importers of such devices could rely only upon conformity assessment certification by the TGA to be included in the Australian Register of Therapeutic Goods (ARTG). The purpose of this guidance is to provide an overview of how manufacturers and importers can seek an expedited application for TGA conformity in order to gain access to the Australian market…
