Left to their own devices: The regulation of cosmetic non-ionising radiation sources in Australia

The regulation of cosmetic devices that use non-ionising radiation (NIR) in Australia is fragmented, internally inconsistent and poorly aligned with risk. While cosmetic NIR devices appear to fall squarely within the statutory definition of medical devices under Commonwealth law, recent regulatory guidance has introduced uncertainty about their status, weakening oversight and enforcement. The article proposes targeted reforms to clarify regulatory status, strengthen enforcement and restore a genuinely risk-based regulatory approach in the interests of consumer safety.