DRUG AND MEDICAL DEVICE LITIGATION
CD: How are you seeing regulatory expectations evolve for drug and medical device manufacturers, particularly as agencies increasingly rely on informal guidance, adaptive oversight or ‘soft law’ approaches?
Williams: Australia’s medicine and medical device regulator, the Therapeutic Goods Administration (TGA), has long had a compliance framework which encourages voluntary compliance through education and prioritises enforcement actions based on risk. It publishes guidance documents on a wide range of topics to assist compliance. However, I do not see that this framework has in any way weakened the TGA’s standards or reduced its resolve to take enforcement action where necessary. Rather, the TGA is expanding the areas where it engages in enforcement actions and in recent years has, for example, achieved a record penalty outcome against a global medical device company for quite a technical breach of its regulatory obligations.
Yeo: Regulatory agencies in Singapore are moving away from static, prescriptive rules toward more flexible, principles-based approaches to oversight that blend safety and quality control with flexibility and guidance. This is reflected in the growing use of guidance instruments, especially for governing emerging developments such as the use of artificial intelligence (AI) and the applications of precision medicine in healthcare. In 2025, the Health Sciences Authority (HSA) published its ‘Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach’, to provide clarity on the regulatory requirements across the product lifecycle. The HSA has also moved toward adaptive oversight.
Jul-Sep 2026 issue
Clayton Utz
DLA Piper
Drew & Napier
Hogan Lovells
McCarthy Tetrault