CDSCO issues draft guidelines to regulate medical device software

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management

To align India’s regulatory framework for medical device software with globally harmonised practices, the Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document for grant of licence to manufacture or import device software for sale and distribution in the country.

 

The CDSCO has broadly classified medical software into two categories. The first includes software integrated into a physical medical device — known as Software in a Medical Device (SiMD) — such as insulin pumps.

 

The second encompasses software that operates independently for medical purposes — referred to as Software as a Medical Device (SaMD) — such as electrocardiogram (ECG) analysis tools. 

   

These two kinds of software products support diagnostics, treatment, and patient monitoring. They are subject to strict regulatory standards to ensure safety, performance, and clinical effectiveness, the regulatory body noted.

 

In an official note dated October 21, the CDSCO stated that the guidelines provide scope, definition, classification, and quality management system requirements for SiMD and SaMD software, including artificial intelligence (AI), machine learning (ML), and Cloud-based medical applications.

 

Currently, the quality standards for medical device software are outlined in the Medical Devices Rules (MDR), 2017.

 

The draft guidance document is open to stakeholder comments for 30 days (up to November 22).

 

Welcoming the move, medical device manufacturer associations have sought streamlined compliance requirements for low-risk SaMDs in the final version of the guidelines.

 

Pavan Choudary, chairman of the Medical Technology Association of India (MTaI), a body representing multinational medtech companies, said by providing clarity on definitions, classification, and quality management requirements, the draft guidelines create a foundation for safe, innovative, and globally competitive medtech software solutions from India.

 

He, however, added that there needs to be greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices.

 

“With digital health solutions playing an increasingly critical role in patient care, it is essential that our regulatory framework ensures both patient safety and innovation,” said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD).

 

He also proposed hosting a webinar to educate stakeholders and invite feedback to align India’s framework with the International Medical Device Regulators Forum (IMDRF) and other global best practices.

 

“This will ensure patient safety while enabling Indian innovations to thrive internationally," he said.

 

Choudary added that the industry looks to continue its engagement with the regulator. This will ensure that the final framework remains innovation-friendly, risk-proportionate, and harmonised with global best practices.