Titans Medical

The meeting is about providing guidance on the regulations and requirements for Medical Device Software in India, as outlined in a draft guidance document by the Central Drugs Standard Control Organization (CDSCO). Draft Guidance Document on Medical Device Software This document outlines the regulatory framework for Medical Device Software under the Medical Devices Rules, 2017, […]

1. Introduction: Why PMS Is Critical for Respiratory Devices Respiratory devices such as ventilators, oxygen concentrators, CPAP/BiPAP units, and nebulizers play a pivotal role in supporting or sustaining breathing. Unlike many lower-risk medical devices, these instruments operate in direct interface with patients’ respiratory systems, often in life-critical scenarios. Even minor failures—such as alarm mis-triggering, sensor

Respiratory devices have become central to India’s healthcare landscape, especially since the COVID-19 pandemic. Ventilators, oxygen concentrators, CPAP/BiPAP machines, and nebulizers were lifelines during the crisis, and today they remain essential in critical care, emergency response, and home healthcare. With this heightened reliance comes stricter regulatory oversight. For manufacturers and importers aiming to enter the

The COVID-19 pandemic reshaped how the world views respiratory care. Devices such as ventilators, oxygen concentrators, CPAP/BiPAP machines, and nebulizers became lifelines during the crisis—and in India, they quickly moved into the spotlight of regulators. Under the Central Drugs Standard Control Organization (CDSCO), respiratory devices now face some of the strictest oversight, making respiratory device

For cardiovascular medical devices—such as stents, pacemakers, and heart valves—the path to market in India is shaped by one key factor: clinical evaluation. Under the Medical Devices Rules (MDR), 2017, the Central Drugs Standard Control Organisation (CDSCO) requires manufacturers to demonstrate safety and performance through structured evidence. At Titans Medical Consulting, we often see companies

Software as a Medical Device (SaMD), especially AI/ML-enabled SaMD, is reshaping diagnosis, monitoring, triage and clinical decisions. Regulators worldwide are racing to balance innovation with patient safety, and India is no exception. This post summarises the regulatory expectations you need to design, document, and market SaMD in India (with practical compliance steps), looks briefly at