Monitoring: Continuously monitor the device’s performance once it’s on the market. This includes collecting feedback from users and healthcare professionals.

Review Regulations: Familiarize yourself with the Medical Devices Rules, 2017, which govern the registration and regulation of medical devices in India. This will help you understand the specific requirements for Class B medical devices.

Medical Devices Rules, 2017: This is the primary regulatory framework for medical devices in India. It outlines the requirements for registration, classification, and compliance of medical devices. For Class B devices, this includes adherence to safety, performance, and manufacturing standards as prescribed.

Detailed Device Information: A comprehensive description of the device, including its design, intended use, and functionality.

Verify Classification: Ensure that your device is correctly classified as Class B according to the CDSCO classification system, which includes moderate-risk devices.

Technical Documentation: Device description, specifications, clinical evidence, and risk analysis.

Device Description: Detailed information about the device’s design, intended use, and functionality.

Verify that your device is correctly classified as a Class B device, which includes moderate-risk devices.