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In the medical device regulatory lifecycle, approval is not the finish line it is the starting point of continuous compliance. One of the most underestimated risk areas for manufacturers and authorized representatives is manufacturing site changes. Whether it is a full relocation, adding a contract manufacturer, or even a warehouse shift, these changes can directly […]

Labeling and Instructions for Use (IFU) are often perceived as administrative updates—something that can be modified late in the product lifecycle without regulatory consequences.In practice, labeling and IFU changes are among the most frequently scrutinized updates by regulators, especially under India’s Medical Device Rules (MDR), 2017. From a regulatory consulting standpoint, we see repeated authority

Once your medical device is approved in India, many manufacturers assume the hard work is over. In reality, post-approval change management is where a large number of regulatory issues, delays, and even license suspensions begin. From a regulatory consultant’s point of view, misclassifying a post-approval change as “minor” when it is actually “major” is one

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