CDSCO issues guidance on regulatory pathway for AI, software-based medical devices
Summary
- The Central Drugs Standard Control Organisation (CDSCO) has issued guidance on the regulatory pathway for AI and software-based medical devices.
- The guidance clarifies how these devices will be regulated under the Medical Devices Rules (MDR), 2017.
- The move aims to provide clarity on the regulatory framework for software-based medical devices, including AI-enabled products.
Key Facts
- · CDSCO has issued guidance on the regulatory pathway for AI and software-based medical devices
- · The guidance is based on the Medical Devices Rules (MDR), 2017
- · The regulation aims to ensure safety and efficacy of software-based medical devices
Why it matters
The guidance provides clarity on the regulatory framework for software-based medical devices, which is essential for ensuring public health and safety.
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