Convergence in the regulation of artificial intelligence software as medical device in the Guangdong-Hong Kong-Macao Greater Bay Area of China

Abstract

The regulatory regime for medical devices in mainland China has widened to include devices enabled with artificial intelligence (AI) or machine learning (ML) and has increased in sophistication in review and oversight requirements, mechanisms and practices since the regime’s introduction in the year 2000. This chapter provides a critical review of this regulatory regime, with a focus on the organisation, guidelines and policies of the National Medical Products Administration, which is the agency responsible for implementing the regime. It then reviews the regulatory approach applied in the jurisdiction of Hong Kong, as a Special Administrative Region of China, along with key policies directed at facilitating regulatory convergence within the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) in southern China. The chapter concludes with an overview of laws on intellectual property and (personal) information/data protection as regulatory regimes that have a strong impact on the development and implementation of medical AI in the GBA.

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