Medical Devices Registration

overview of Medical Device Import License by CDSCO - MD 15 License The Indian medical device industry heavily relies on imports to meet its demand for a wide range of healthcare devices. While India has a growing domestic manufacturing sector, it is still largely dependent on imported medical devices to fulfil the requirements of its healthcare system. To import medical devices, including in-vitro diagnostic devices, into India, it is mandatory for the importer to obtain a medical device import license (MD 15 License) from the Central Drugs Standard Control Organization (CDSCO). This requirement is outlined in the Medical Device Rules of 2017, which govern the import, manufacturing, distribution, and sale of medical devices in India.

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in ensuring the safety and quality of medical devices imported into India. As part of its regulatory oversight, the CDSCO issues medical device import licenses to authorized agents who comply with the established rules and regulations.

CDSCO grants licenses through a structured process involving evaluation, inspection, and strict criteria adherence. Their aim is to safeguard public health and ensure the entry of safe and effective medical devices into India.

Medical devices in India are classified into four classes based on the level of risk they pose to patients. All medical devices, including in-vitro diagnostic devices, are subject to this classification system.