Regulatory Compliance: Follow updates to the Medical Device Rules (MDR) 2017 and any additional guidelines issued by CDSCO.

Adherence to MDR 2017: Continue to comply with the Medical Device Rules (MDR) 2017, including all stipulations related to device safety, effectiveness, and quality management.

Familiarize with MDR 2017: Review the Medical Device Rules (MDR) 2017 to understand the specific requirements and processes for Class C medical devices.

Monitor Device Performance: Implement a robust post-market surveillance system to continuously monitor the device’s performance, safety, and effectiveness once it is on the market.

Regulatory Framework: The Medical Device Rules, 2017, outline the regulatory requirements for medical devices in India, including those for Class C devices. These rules specify the procedures for registration, the documentation required, and the compliance obligations for manufacturers and importers.

Detailed Description: A comprehensive description of the medical device, including its intended use, design, components, and functionalities.

Initial Processing: Upon submission of your application through the SUGAM portal, CDSCO typically acknowledges receipt and begins the initial review. This can take about 2 to 4 weeks.

Class C Classification: Ensure your device is correctly classified as Class C based on CDSCO guidelines. Class C devices are high-risk devices that require more stringent controls compared to lower-class devices.