The requirements for Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India are designed to ensure the safety, efficacy, and quality of high-risk devices. Here’s a detailed breakdown of these requirements:

1. Application Form

• SUGAM Portal: Complete the application form on the CDSCO SUGAM portal, which is the online system for medical device registrations.

2. Technical Documentation

• Device Description: Detailed description of the medical device, including its intended use, design, and operation.
• Technical File: Includes detailed technical information about the device, such as specifications, component details, and manufacturing processes.
• Clinical Evaluation Report: Clinical data demonstrating the safety and effectiveness of the device, often supported by clinical trials or studies.
• Risk Management File: Documentation outlining the risk assessment and management processes associated with the device.

3. Manufacturing and Quality Certifications

• ISO 13485: Certification for Quality Management Systems (QMS) specific to medical devices.
• GMP Compliance: Proof that the manufacturing facility complies with Good Manufacturing Practices.

4. Labeling and Packaging

• Labeling Information: Detailed labels including device name, intended use, manufacturer details, and any warnings or precautions.
• Packaging Information: Information about the packaging materials and methods used to ensure the device's integrity and safety.

5. Safety and Efficacy Data

• Pre-market Clinical Data: Evidence from clinical trials or studies that supports the device's safety and efficacy.
• Post-market Surveillance Plan: Plan for monitoring the device’s performance once it is on the market, including reporting adverse events.

6. Fees

• Registration Fees: Payment of the applicable registration fee as specified by CDSCO. This can usually be done online through the SUGAM portal.

7. Quality Management System (QMS)

• Documentation: Evidence of a robust Quality Management System in place, including procedures and records related to device development, manufacturing, and post-market activities.

8. Compliance with Standards

• ISO and IEC Standards: Compliance with relevant international standards and guidelines, which may include ISO, IEC, or specific standards related to the device type.

9. Other Requirements

• Manufacturing License: Copy of the manufacturing license issued by the regulatory authority of the country where the device is manufactured.
• Import License (if applicable): For imported devices, an import license issued by CDSCO.

10. Additional Information

• Device Classification: Ensure that your device is correctly classified as Class C according to the CDSCO classification system. This classification determines the regulatory requirements and procedures.
• Risk Classification: Provide detailed risk classification and management documentation specific to Class C devices.

Process Summary

1. Preparation: Collect and prepare all necessary documentation.
2. Application Submission: Submit the application through the SUGAM portal, including all required documents and fees.
3. Review and Inspection: CDSCO will review the application and may conduct an inspection of the manufacturing facility.
4. Approval: Upon successful review, CDSCO will issue the registration certificate.

Ensure compliance with all CDSCO guidelines and maintain up-to-date knowledge of any changes in regulations.

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