Dear members, TGA has released their enforcement priorities for 2026-2027, with Direct to consumer IVDs being No. 1 on the list and Software as a Medical Device being No. 7 of the twelve key areas that they intend to focus on. The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The TGA Compliance Principles 2026…
Ben KempFebruary 6, 2026
US based MDIC (Medical Device Innovation Consortium) have issued their ‘ The Standardized Framework for Specimen Stability Study Design and Analysis ‘ guidance document.
Ben KempFebruary 6, 2026
New and updated standards Shop | Clinical & Laboratory Standards Institute Includes M100 Antimicrobial Susceptibility Testing 2026 EP05 Plus – Evaluation of Precision of Quantitative Measurement Procedures 4th Ed Dec 2025 MM19 – Establishing Molecular Testing in Medical Laboratory Environments Nov 2025 Documents for Public Review | CLSI EP17-Ed3 (Proposed Draft) - Evaluation of Detection Capability for Medical Laboratory…
Ben KempFebruary 6, 2026
The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health. The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for…
Ben KempJanuary 23, 2026
IPO fees to increase from 1 April 2026 We wrote to you in November announcing a fee increase across all IP rights, due to come into effect on 1 April 2026, subject to parliamentary approval. Fees will be increasing by an average of 25%. For example, a patent search is going up from £150 to £200 and a trade mark…
Ben KempJanuary 23, 2026
Enhancing collaboration for health security Enhanced cooperation was at the forefront of the Health Security Committee (HSC) plenary in Brussels on 14-16 January 2026, with discussions focussed on enhancing health security preparedness and protecting citizens. The meeting took place back-to-back with a meeting of the G7 Global Health Security Initiative, highlighting the benefits of global collaboration in the face of…
Ben KempJanuary 23, 2026