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Software as a Medical Device (SaMD) is enabling faster innovation, smarter diagnostics, and scalable healthcare solutions. However, as software-driven products move closer to clinical decision-making, regulatory classification has become one of the most critical and misunderstood aspects of market access. Many SaMD manufacturers invest heavily in development and validation, only to encounter challenges later due […]

Submitting a medical device application on the CDSCO SUGAM portal is only half the job. What truly decides approval timelines is how well the dossier aligns with CDSCO’s expectations during scrutiny. Many applications don’t get rejected outright—but they stall, sometimes for months, due to avoidable queries. Based on real regulatory reviews and CDSCO scrutiny patterns,

Ensuring the continued safety, quality, and performance of medical devices after they are placed on the Indian market is a core requirement of the Medical Devices Rules, 2017 (MDR 2017).Post-market surveillance (PMS) is not optional CDSCO expects every manufacturer and importer to build a structured PMS system that actively collects, investigates, and reports safety information

As India moves toward stronger evidence-driven medical device regulation, manufacturers often assume that an India-specific clinical investigation is mandatory for every new import or registration. Under MDR 2017 and the subsequent guidance updates, this is not always true. In fact, CDSCO increasingly accepts Real-World Evidence (RWE) as a valid form of clinical validation if the

Global medical device manufacturers expanding into India often ask a common question: “Can we reuse our FDA or CE evidence for CDSCO registration?”The short answer: Yes, if the data is mapped, justified, and repurposed correctly. India’s regulatory framework under the CDSCO Medical Device Rules, 2017 (MDR 2017) strongly emphasises safety, performance, and clinical evaluation. This

Medical device approvals in India under the Medical Device Rules (MDR) 2017 have become more structured and predictable, but delays still occur frequently. While standard CDSCO timelines range from four to nine months depending on device class and dossier complexity, many applications experience setbacks of one to three months due to avoidable mistakes in documentation,