New Delhi, Oct 22 – Industry groups in India welcomed a draft guidance from the Central Drugs Standard Control Organisation (CDSCO) on medical device software. The guidance aims to clarify rules for both “Software in a Medical Device” (SiMD) and “Software as a Medical Device” (SaMD), and to align India’s standards with global best practices.
The CDSCO issued an official notice on Tuesday that the draft covers definitions, classifying software, required technical documents, and quality‑management systems. “These guidelines will help companies apply for licences to manufacture or import medical software for sale in India,” said Dr. Rajeev Singh Raghuvanshi, India’s drug regulator and head of CDSCO.
Medical device software powers diagnostics, treatment, and patient monitoring. It must meet stringent regulatory standards to protect patients and prove effectiveness.
Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), praised the update. “This draft is a timely step to strengthen India’s regulatory ecosystem. Digital health plays an increasingly vital role in care, and our rules must keep pace with patient safety and innovation,” he said. Nath suggested hosting a webinar to educate stakeholders and gather feedback, aiming to bring India in line with the International Medical Device Regulators Forum (IMDRF) and other global benchmarks.
The Medical Technology Association of India (MTaI) also welcomed the draft. MTaI Chair Pavan Choudary called the guidance “a comprehensive framework for SiMD, SaMD, AI, machine learning, and cloud‑based medical applications.” He added that clear definitions and quality‑management requirements lay the groundwork for safe, innovative, and globally competitive Indian MedTech software.
MTaI urged CDSCO to streamline compliance for low‑risk SaMDs, to match technical and quality standards with worldwide norms, and to clarify clinical evaluation and algorithm‑change procedures, especially for AI/ML devices.
The draft guidance is expected to make it easier for Indian companies to bring digital health solutions to market while ensuring patient safety.
Source: ianslive
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