Harmonisation for Australia and NZ on the Horizon
Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The jo
The TGA and Local Representative Requirements
The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&
Health Canada Makes Changes to Medical Device Establishment Licensing Framework
Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medica
