Articles

In the highly regulated world of medical technology, maintaining uncompromising quality standards is not just good practice, it’s a legal necessity. A Medical Device Quality Management System (QMS) forms the foundation of regulatory compliance, ensuring that every stage of production – from design and manufacturing to distribution – meets global safety and quality standards. For […]

Earlier this year Australia’s medical device landscape entered a new era of post-market regulation. On 5 March 2025, the Therapeutic Goods Administration (TGA) implemented the Procedures for Recalls, Product Alerts, and Product Corrections (PRAC) — a major overhaul of Australia’s recall and post-market surveillance system. This new framework replaced the former Uniform Recall Procedure for

The medical technology (medtech) industry is transforming health care at an unprecedented pace. Artificial intelligence, data analytics and 3D printing are no longer futuristic concepts – they are reshaping diagnostics, surgery and patient care today. Yet behind every breakthrough lies an essential foundation: Intellectual property (IP). For innovators in this fast-evolving sector, protecting IP is

The Therapeutic Goods Administration (TGA) has introduced a major update to the Essential Principles (EP) checklist for medical devices and in vitro diagnostics (IVDs), effective September 2025. This update incorporates new requirements related to the Unique Device Identification (UDI) framework—an important step in strengthening device traceability, post-market surveillance and regulatory alignment with international standards such

As medicinal cannabis becomes a more common treatment option in Australia, healthcare practitioners face increasing scrutiny from regulators and medical boards. Understanding the rules around prescribing, advertising and telehealth is essential to maintaining compliance and protecting your registration. At Lodestar Legal, our medicinal cannabis lawyers specialise in supporting clinicians, doctors, and allied health professionals working

Helping Cannabis Businesses Succeed Within Australia’s Regulatory Framework The Australian medicinal cannabis industry presents significant commercial opportunity, but also complex regulatory risk. From licensing, warehousing and advertising to telehealth operations and ethical governance, compliance is critical to building a sustainable and legally sound business. At Lodestar Legal, our medicinal cannabis lawyers advise corporate clients across