Why is it so important to review and update your regulatory strategy?
Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with
US Food and Drug Administration (FDA) Issue New Regulatory Guidance
The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical devic
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
Six Essential Web Resources, Australian Medical Device & IVDs
The internet is a vast resource and hunting through available information can be time consuming – making it difficult for you to find what you need, when you need it. As an Aust
Joint Implants: 4 Corners, the TGA, and Proposed Reforms
The 4 Corners program on ABC television which aired on the 16th of May explored the failure and subsequent recall of the DePuy Orthopaedics ASR hip replacement device, raising ques
