Recent Posts

US FDA 510(k) Reviews: Handling Deficiency Letters or AI Letters

CDSCO Medical Device regulations registration in India

Impact of Design Changes on CDSCO approved Medical Devices

Navigating the Current Medical Device Regulatory Scenario in India: Insights from Our Upcoming Webinar

Substantial Equivalence Medical-Devices US FDA 510k registration

Substantial Equivalence for Medical Devices for successful US FDA 510(k) registration

Choosing the Right Type of US FDA 510(k) Premarket Notification for Your Medical Device: Understanding the Options

Creating an Account in the SUGAM Online Portal and Leveraging the National Single Window System

Post approval changes in Change in Constitution of manufacturer or IAA

Impact of Post Approval Changes in Constitution of the Indian Authorized Agent (IAA) or Manufacturer on India Medical Device Approvals

Post Approval Change Notifications and Their Intimation Timelines

Online application for Obtaining Neutral code for Medical Devices Manufactured for Export purpose

February 21, 2024

US FDA 510(k) Pre-Market Notification (PMN) Submission requirements for Sterile Medical Devices

February 13, 2024

Thank you The Global Hues for the Cover Story on 8C Healthcare contribution to Medical Device and Diagnostics Industry.

June 24, 2022

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

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