Monitoring Imported Medical Devices Quality: Risk-based Approach

by Sudhriti M | Jan 24, 2025 | Medical Device, Medical Device License Requirements

The Indian government aims to regulate the quality of imported medical devices. It wants to ensure only high-quality medical devices enter the Indian market. The aim is to prevent substandard medical devices from reaching Indian patients, thereby protect the public...

Quality Control for Medical Textiles: Overview of the New Order

by Sudhriti M | Jan 24, 2025 | Medical Device, Medical Device License Requirements

Medical device quality and safety have been the top priority for India’s medical device regulatory authorities. Given the impact of medical devices on healthcare, quality of their raw materials has to be strictly regulated as well. Hence, the Indian Ministry of...

Documents Required for CDSCO MD-15 License Application: Your Guide

by Sudhriti M | Jan 8, 2025 | Medical Device, Medical Device License Requirements

The CDSCO MD 15 license is granted for importing medical devices into India. It is the gateway for importing and selling imported medical devices in India. MD-15 license is a mandatory requirement for importing all Class A (measuring and sterile) B, C, and D medical...

CDSCO Gynaecological Medical Device License: Your Guide

by Sudhriti M | Nov 27, 2024 | Medical Device, Medical Device License Requirements

 Securing the CDSCO license for gynaecological medical devices is mandatory to launch your devices in the Indian medical device market. This requirement is in place to protect the public health and maintain the standard of the Indian healthcare system. To manufacture...

CDSCO Operation Theatre Medical Device License Application

by Sudhriti M | Nov 22, 2024 | Medical Device, Medical Device License Requirements

Operation theatre medical devices have a crucial role in facilitating surgeries and ensuring positive patient outcome. In addition to specialized equipment, basic general operation theatre medical devices, such as surgical table, have equally important roles....

CDSCO General Hospital Medical Devices License: Your Guide

by Sudhriti M | Nov 21, 2024 | Medical Device, Medical Device License Requirements

Medical devices used by healthcare professionals to administer treatment and provide patient care fall under general hospital medical devices category. These are basic common medical devices required to provide treatments planned in the hospital. Additionally, general...