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CDSCO Releases Guidelines for Medical Software and AI Devices
· Source: Amar Ujala
New guidelines ease the licensing process for medical software companies, removing the need for a new licence for minor software changes. The framework addresses the growing use of AI-based medical software in hospitals and clinics.
Relief for Medical Software Companies
Under the new guidelines, companies will no longer need to obtain a new licence for small modifications made to software. Updates such as algorithm modifications can now be implemented directly. Additionally, the process of acquiring test licences and commercial licences has been simplified and clarified.
Two Categories of Medical Software
The new guidelines divide medical software into two distinct categories:
- Software in Medical Device: This refers to software embedded inside a medical machine that drives the machine itself, such as the software used in pacemakers, blood pressure monitors, or insulin pumps. The regulations applied to the respective machine will also apply to this software.
- Software as a Medical Device: This refers to software that functions independently without being attached to a medical machine. Examples include software that identifies tuberculosis by analyzing X-rays, or cloud-based software that suggests cancer treatment based on patient data.
Reason Behind the New Guidelines
Medical software is increasingly being adopted across hospitals and clinics, playing a growing role in AI-based diagnostics, disease monitoring, and treatment. Because the Medical Device Rules, 2017 were designed primarily keeping physical medical machines in mind, software manufacturers, importers, and researchers faced multiple difficulties.
Questions
Do companies need a new licence for small software updates?
No, companies are no longer required to get a new licence for minor modifications, including algorithm updates.
What is 'Software in Medical Device'?
It is software built into a medical machine that operates the device, such as software in a pacemaker, insulin pump, or blood pressure machine.
What is 'Software as a Medical Device'?
It is software that works independently without a medical machine, such as X-ray analysis software for tuberculosis detection or cloud-based software for cancer treatment advice.
Why were the Medical Device Rules 2017 problematic for software makers?
The Medical Device Rules, 2017 were created primarily for physical medical machines, creating difficulties for software developers, importers, and researchers.
Written in English by Disha Stars from the Amar Ujala report (read the original in Hindi). Check dates and links on the official website before you act.
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