For CDSCO (Central Drugs Standard Control Organization) registration of Class B medical devices in India, several requirements must be met. These requirements ensure that the device meets the necessary safety, efficacy, and quality standards. Here’s a detailed overview of the requirements:

1. Device Classification

• Class B Device: Confirm that your device is classified as Class B, which typically includes moderate-risk devices. The classification determines the level of regulatory scrutiny.

2. Technical Documentation

• Device Description: Provide a detailed description of the device, including its intended use, design, and functioning.
• Labeling: Submit labeling information, including instructions for use, packaging details, and warnings.
• Manufacturing Process: Include details about the manufacturing process, including quality control measures and testing procedures.

3. Quality Management System

• GMP Compliance: Ensure compliance with Good Manufacturing Practices (GMP) or ISO 13485 standards. Provide documentation demonstrating adherence to these standards.
• Quality Assurance: Include information on the quality management system in place to ensure device safety and effectiveness.

4. Clinical Evidence

• Clinical Evaluation: Provide clinical evaluation reports or studies demonstrating the safety and efficacy of the device. This may include clinical trials or post-market studies.
• Risk Management: Include a risk analysis report assessing potential risks associated with the device and how they are managed.

5. Regulatory Certificates

• Foreign Certificates: If applicable, provide copies of regulatory approvals from other countries (e.g., CE marking for devices marketed in Europe).
• Manufacturing License: If manufacturing within India, include a copy of the manufacturing license.

6. Pre-Market Approval

• Application Form: Complete the application form available on the CDSCO SUGAM portal.
• Document Submission: Upload all required documents, including technical data, clinical evidence, and regulatory certificates.
• Fee Payment: Pay the required application fee. The fee amount may vary depending on the device and its classification.

7. Facility Information

• Manufacturing Facility: Provide details about the manufacturing facility, including its address, and operational processes.
• Inspection: Be prepared for a facility inspection by CDSCO, if required, to verify compliance with GMP and other regulations.

8. Regulatory Compliance

• Adverse Event Reporting: Have a system in place for monitoring and reporting adverse events or device-related issues post-market.
• Post-Market Surveillance: Implement procedures for ongoing monitoring of the device’s performance and safety in the market.

9. Additional Information

• Technical Data: Provide any additional technical data or information as requested by CDSCO during the review process.
• Updates: Keep CDSCO informed of any changes to the device, manufacturing process, or labeling.

Summary

• Ensure Compliance: Adhere to all CDSCO regulations and standards.
• Document Preparation: Prepare comprehensive documentation including device details, clinical evidence, and manufacturing information.
• Online Application: Submit the application and required documents through the CDSCO SUGAM portal.
• Inspection: Be prepared for a facility inspection if required.
• Ongoing Compliance: Maintain compliance with regulatory requirements throughout the device’s lifecycle.

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