Regulation of Software as a Medical Device (SaMD) in India: A Beginner’s Guide
With rapid technological advancements, the healthcare industry is evolving at an unprecedented pace. As a result, a wide range of […]
With rapid technological advancements, the healthcare industry is evolving at an unprecedented pace. As a result, a wide range of […]
For the manufacture, import, and distribution of medical devices in India, companies must understand the regulatory procedures not only for
In vitro diagnostics (IVDs) are essential tools in modern healthcare, used extensively worldwide for disease diagnosis, monitoring, and personalized medicine.
India’s rapid industrial growth, driven by rising consumer demand, has led to a surge in environmental pollution, particularly from plastic
For the manufacture/import and sale of medical devices in India, they must comply with the Medical Device Rules, 2017, which
The Indian medical device market is advancing rapidly and is currently valued at approximately USD 12 billion, which is expected
In India, the manufacturing, sale, and distribution of medical devices are subject to stringent regulatory requirements designed to ensure that
In India, the manufacture, import, and distribution of medical devices are regulated by the Central Drugs Standards Control Organization (CDSCO)
Over the last decade, the medical device industry in India has experienced remarkable growth, driven by increasing demand for a