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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
Sterilization Validation & GHTF Harmonization for the Indian Market Read More »
Ensuring patient safety doesn’t end with regulatory approval—it continues throughout the entire lifecycle of your device. For medical device manufacturers, two pillars of compliance and safety stand out: biocompatibility testing and post-market surveillance (PMS). This blog will guide you through the essentials of both, based on official global regulatory guidance from FDA, WHO, and MHRA,
Introduction In India, dental devices—from implants to orthodontic brackets—must meet strict regulatory standards before entering the market. A Device Master File (DMF) is one of the most critical documents in the Central Drugs Standard Control Organization (CDSCO) registration process. The DMF serves as a comprehensive dossier that demonstrates the safety, quality, and performance of a
Creating a Compliant DMF for Dental Devices – CDSCO Expectations Read More »
Bringing a medical device into the Indian market is more than just ticking boxes—it’s about navigating a dense regulatory landscape, starting with the Free Sale Certificate (FSC). Whether you’re a foreign manufacturer seeking CDSCO registration or an Indian importer managing timelines and documentation, understanding Indian FSC requirements is critical for a smooth registration process. This
Understanding Indian FSC Requirements & Import Challenges for Medical Devices Read More »
