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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

India’s Growing Cardiovascular Device Market The burden of cardiovascular disease in India has been rising steadily, driven by lifestyle changes, an aging population, and increasing awareness of early diagnosis and treatment. This surge has created a strong demand for advanced cardiovascular medical devices—ranging from stents, pacemakers, cardiac monitoring systems, implantable defibrillators, and prosthetic heart valves.

Sterilization validation is more than a regulatory requirement; it is a vital assurance that medical devices reaching patients are consistently sterile, safe, and effective. For manufacturers in India, demonstrating a robust sterilization validation program is not only necessary for Central Drugs Standard Control Organization (CDSCO) approvals but also for building credibility in global markets. Why