To apply for CDSCO registration of Class B medical devices in India, you need to meet several conditions and requirements to ensure a smooth application process. Here's a summary of the key conditions:

1. Device Classification

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

2. Compliance with Indian Regulations

• Manufacturing Compliance: The device must be manufactured in compliance with Indian regulations. If manufactured abroad, ensure that the manufacturing facility adheres to Good Manufacturing Practices (GMP) or equivalent standards.

3. Documentation Requirements

• Technical Documentation: Prepare comprehensive technical documentation, including:

  • Device Description: Detailed description of the device, including its intended use and functionality.
  • Clinical Evidence: Clinical evaluation reports or studies demonstrating the safety and efficacy of the device.
  • Risk Analysis: Document risk management practices and assessments.

• Quality Management Documentation: Provide evidence of compliance with quality management standards, such as:

  • GMP Certificate: Proof of adherence to Good Manufacturing Practices or ISO 13485 certification.
  • Manufacturing Process Details: Information on quality control and testing procedures.

• Labeling and Packaging: Submit draft labels and packaging information, including:

  • Labels: Information on the device’s intended use, instructions, warnings, and precautions.
  • Packaging: Details on packaging design and materials.

• Regulatory Certificates: If applicable, include:

  • Foreign Regulatory Approvals: Copies of approvals from other regulatory bodies (e.g., CE marking).
  • Manufacturing License: A copy of the manufacturing license if the device is produced in India.

4. Application Form and Fee

• Complete Application Form: Fill out the application form available on the SUGAM portal with accurate and complete information.
• Pay Application Fee: Submit the application fee online as specified by CDSCO. The fee amount depends on the type of device and other factors.

5. Facility Compliance

• Inspection Readiness: Be prepared for a potential facility inspection to verify compliance with GMP and other regulatory requirements. Ensure that all aspects of the manufacturing facility are in order and compliant with standards.

6. Clinical and Technical Standards

• Adherence to Standards: Ensure that the device meets relevant technical and clinical standards required by CDSCO. This includes safety, efficacy, and performance standards applicable to Class B devices.

7. Legal and Regulatory Representation

• Authorized Representative: If the manufacturer is located outside India, appoint an authorized Indian representative or agent who will handle regulatory affairs and communication with CDSCO.

8. Post-Market Obligations

• Post-Market Surveillance: Be prepared to monitor the device post-market and report any adverse events as required by CDSCO regulations.

Summary

• Classification: Confirm the device is a Class B device.
• Compliance: Adhere to Indian and international regulatory standards.
• Documentation: Prepare and submit all required technical, quality management, labeling, and regulatory documents.
• Application Form and Fee: Complete and pay the application fee on the SUGAM portal.
• Facility Readiness: Ensure compliance with GMP and prepare for possible inspections.
• Authorized Representative: Appoint an Indian representative if the manufacturer is abroad.
• Post-Market: Be ready for post-market surveillance and reporting.

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