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When medical device companies plan international market entry, one of the most common assumptions is that approval in one region will make approval in another easier. In practice, this is rarely true. India, the United States, and the European Union follow very different regulatory philosophies, documentation expectations, and review behaviors. Submissions that succeed in one […]
Software as a Medical Device (SaMD) is increasingly important in healthcare innovation, standalone software that performs medical purposes such as diagnosis, monitoring, prediction, or treatment without requiring a physical hardware medical device. In India, SaMD falls under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) as defined by the Medical Devices Rules,
Understanding Predicate Device Challenges for Novel SaMD Products under CDSCO Read More »
Introduction A Free Sale Certificate (FSC) is often the final regulatory milestone before a medical device manufacturer or authorized agent can access international markets. Issued by the national regulatory authority (such as CDSCO in India), an FSC confirms that a medical device is legally marketed and compliant in its country of origin. However, one of
FSC Rejection Due to Undeclared Post-Approval Modifications Read More »
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
Manufacturing Site Changes and Their Impact on Existing Licenses Read More »
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
Labeling and IFU Changes That Trigger Regulatory Scrutiny Read More »
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
What Constitutes a Major vs Minor Post-Approval Change Under India MDR? Read More »
