( September 14, 2026, 08:37 GMT | Official Statement) -- MLex Summary: China’s National Medical Products Administration on Monday released a new industry standard setting quality requirements and evaluation methods for electrical brain-signal datasets used by artificial intelligence algorithms in brain-computer interface, or BCI, medical devices. The regulator said it is China’s third BCI medical-device standard and the world’s first product standard for BCI medical devices that use AI to process such data. The standard covers data collection, processing, labeling, storage and access, and is intended to provide a common quality benchmark for datasets used in BCI product development, manufacturing and quality control. The standard is set to take effect Sept. 1, 2027.Statement follows (in Chinese)....
Prepare for tomorrow’s regulatory change, today
MLex identifies risk to business wherever it emerges, with specialist reporters across the globe providing exclusive news and deep-dive analysis on the proposals, probes, enforcement actions and rulings that matter to your organization and clients, now and in the longer term.
Know what others in the room don’t, with features including:
- Daily newsletters for Antitrust, M&A, Trade, Data Privacy & Security, Technology, AI and more
- Custom alerts on specific filters including geographies, industries, topics and companies to suit your practice needs
- Predictive analysis from expert journalists across North America, the UK and Europe, Latin America and Asia-Pacific
- Curated case files bringing together news, analysis and source documents in a single timeline
Experience MLex today with a 14-day free trial.