To apply for Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India, certain conditions and prerequisites must be met. These ensure that the device complies with regulatory standards and is safe and effective for use. Here’s a comprehensive overview of these conditions:

1. Device Classification

• 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.

2. Manufacturing Compliance

• Good Manufacturing Practices (GMP): The manufacturing facility must comply with Good Manufacturing Practices. This includes having a quality management system in place and following standard operating procedures to ensure consistent quality.
• Manufacturing License: You must have a valid manufacturing license issued by the relevant authority in the country where the device is manufactured. For Indian manufacturers, this means holding a valid license from CDSCO.

3. Quality Management System

• ISO 13485 Certification: The device manufacturer should have ISO 13485 certification, which covers quality management systems specific to medical devices. This certification demonstrates that the manufacturer meets international standards for quality control.

4. Clinical Evaluation

• Clinical Data: Provide robust clinical data to demonstrate the safety and efficacy of the device. This may include clinical trial results, scientific literature, and other relevant studies. Clinical evaluations should be conducted in accordance with accepted standards and practices.

5. Risk Management

• Risk Management Plan: Implement a comprehensive risk management plan that identifies, assesses, and mitigates potential risks associated with the device. This plan should include a detailed risk analysis and management strategies.

6. Labeling and Packaging

• Labeling: Ensure that the device labeling meets CDSCO requirements, including information on intended use, warnings, instructions for use, and manufacturer details.
• Packaging: The device’s packaging must be designed to protect it from damage and contamination during transportation and storage. Include information on packaging materials and methods.

7. Documentation Requirements

• Technical File: Prepare a detailed technical file that includes design, manufacturing processes, performance specifications, and other relevant information about the device.
• Regulatory Documentation: Ensure that all required regulatory documents are completed accurately and are up-to-date. This includes application forms, risk management documentation, and quality management system certifications.

8. Import Requirements (if applicable)

• Import License: If the device is being imported into India, obtain a valid import license from CDSCO. This license is necessary for devices manufactured outside of India.

9. Authorization Letter (if applicable)

• Authorization Letter: If a foreign manufacturer is involved, provide a letter of authorization from the manufacturer authorizing the Indian applicant to act on their behalf.

10. Compliance with CDSCO Regulations

• Regulatory Compliance: Ensure compliance with all CDSCO regulations and guidelines related to medical devices. This includes adhering to any specific requirements outlined by CDSCO for Class C devices.

11. Financial Requirements

• Fee Payment: Be prepared to pay the applicable registration fees. Fees can vary depending on the type and complexity of the device.

12. Facility Inspection

• Inspection Readiness: Be prepared for a possible inspection of the manufacturing facility by CDSCO. The inspection will assess compliance with manufacturing practices and quality control standards.

13. Post-Market Surveillance

• Monitoring and Reporting: Implement systems for post-market surveillance to monitor the device’s performance once it is on the market. Be prepared to report any adverse events or issues to CDSCO as required.

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