How Indian Manufacturers Can Enter the EU Medical Device Market
The European Union (EU) is one of the largest and most lucrative medical device markets in the world. While it […]
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
Understanding Accessories to Medical Devices in India
For the manufacture, import, and distribution of medical devices in India, companies must understand the regulatory procedures not only for
IVDs Registration in India
In vitro diagnostics (IVDs) are essential tools in modern healthcare, used extensively worldwide for disease diagnosis, monitoring, and personalized medicine.
A Step-by-Step Guide to EPR Registration (Plastics, E-Waste, Batteries) in India
India’s rapid industrial growth, driven by rising consumer demand, has led to a surge in environmental pollution, particularly from plastic
Labeling Requirements for Medical Devices (wrt MDR 2017 & amendments thereof)
For the manufacture/import and sale of medical devices in India, they must comply with the Medical Device Rules, 2017, which
How a Regulatory Strategy Report Can Help in Medical Device Introduction in India
The Indian medical device market is advancing rapidly and is currently valued at approximately USD 12 billion, which is expected
A Guide to Legal Metrology Compliance for Medical Devices in India
In India, the manufacturing, sale, and distribution of medical devices are subject to stringent regulatory requirements designed to ensure that
A Comprehensive Guide on “Non-Conviction Certificate” for Medical Devices
In India, the manufacture, import, and distribution of medical devices are regulated by the Central Drugs Standards Control Organization (CDSCO)