Thank you The Global Hues for the Cover Story on 8C Healthcare contribution to Medical Device and Diagnostics Industry.
We are a passionate team of “8” medical device professionals driven by the purpose to contribute to human welfare, by fostering medical device innovations that help in the prevention, diagnosis, or treatment of human ailments,” says Naresh Kumar Pagidimarry, Co-Founder & MD, 8C Healthcare
Device Master File (DMF): Critical Component for Medical Device CDSCO Registration in India
The Device Master File (DMF) is a comprehensive document that provides detailed information about a medical device. It is a critical component of the medical device registration process in India, and is required for all Class A (Measuring and Sterile), Class B, Class C, and Class D medical devices. It provides the CDSCO with comprehensive […]
Plant Master File (PMF) for Medical Device Registrations with CDSCO India
A Plant Master File (PMF) is a comprehensive document that provides detailed information about a manufacturing facility. It is a mandatory requirement for the registration of all Class A (Measuring and Sterile), Class B, Class C, and Class D medical devices in India. The PMF is used by the Central Drugs Standard Control Organization (CDSCO) […]
Registration of Overseas Medical Devices and IVDs in India – Import License from CDSCO
In India, the registration of overseas medical devices and In Vitro Diagnostics (IVDs) is a crucial step to ensure the quality and reliability of these products in the Indian market. The Central Drugs Standard Control Organization (CDSCO) is the regulatory body responsible for overseeing and granting import licenses for these essential healthcare tools. In this […]
