A new article in BIO Integration journal discusses the importance of a comprehensive regulatory model for medical devices to ensure their safety and efficacy. The model includes key components and processes for effective regulation, based on data and literature collected from various sources. Different guidelines and risk classifications exist for medical devices, with varying regulatory requirements across countries. The article emphasizes global regulations for device approval to safeguard public health. The proposed model includes a risk-based classification system, rigorous pre-market requirements, and market authorization pathways. It promotes international harmonization and collaboration, innovation, and continuous improvement through regulatory science research and stakeholder engagement.
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A comprehensive regulatory model to ensure safety and quality of medical devices
