The process for registering a Class C medical device with the Central Drugs Standard Control Organization (CDSCO) in India involves several detailed steps. Here's a comprehensive guide:

1. Pre-Application Preparation

1.1. Understand Regulations

• Review Medical Device Rules (MDR) 2017: Familiarize yourself with the requirements for Class C devices, which are categorized as high-risk devices.
• Consult Standards: Ensure compliance with relevant ISO standards such as ISO 13485 for Quality Management Systems.

1.2. Technical Documentation

• Prepare Technical File: Compile documentation including device description, design, manufacturing processes, and clinical data.
• Risk Management: Document risk management processes according to ISO 14971.
• Clinical Evidence: Gather clinical data or evidence demonstrating the device’s safety and efficacy.

1.3. Quality Management System (QMS)

• ISO Certification: Obtain ISO 13485 certification for your QMS if not already in place.
• Good Manufacturing Practices (GMP): Ensure compliance with GMP guidelines.

2. Application Process

2.1. Create a CDSCO SUGAM Account

• Registration on SUGAM Portal: Create an account on the CDSCO SUGAM portal for online submission of applications.

2.2. Prepare and Submit Application

• Complete Application Form: Fill out the application form for Class C medical device registration on the SUGAM portal.
• Upload Documents: Attach all required documents, including:
  • Technical file
  • Risk management report
  • Clinical evaluation report
  • ISO 13485 certification
  • Proof of GMP compliance
  • Labeling and packaging information
• Payment: Pay the application fees as per CDSCO’s fee structure. Keep proof of payment.

2.3. Application Review

• Initial Review: CDSCO will conduct an initial review of the submitted application and documentation.
• Additional Information: Respond promptly to any requests for additional information or clarification from CDSCO.

2.4. Facility Inspection

• Prepare for Inspection: Ensure your manufacturing facility complies with CDSCO standards and is prepared for inspection.
• Inspection: CDSCO may conduct an on-site inspection of your facility to verify compliance with regulatory requirements.

3. Post-Application Steps

3.1. Decision and Certification

• Approval: Upon successful review and inspection, CDSCO will issue a registration certificate for the Class C medical device.
• Certificate Issuance: Obtain the official registration certificate and maintain it as part of your device’s regulatory documentation.

3.2. Post-Market Requirements

• Post-Market Surveillance: Implement and maintain a system for monitoring the device’s performance, including reporting any adverse events to CDSCO.
• Renewal: Track the registration’s validity period and apply for renewal as required.

3.3. Compliance and Reporting

• Regulatory Updates: Stay updated with any changes in regulations or guidelines and ensure ongoing compliance.
• Labeling and Documentation: Ensure that all labeling and documentation are updated as necessary and compliant with CDSCO regulations.

Summary of Key Steps

1. Pre-Application: Understand regulations, prepare technical documentation, and ensure QMS compliance.
2. Application: Create a SUGAM account, complete and submit the application form, upload documents, and pay fees.
3. Review: Address any queries from CDSCO and prepare for facility inspection.
4. Post-Application: Obtain the registration certificate, implement post-market surveillance, and stay compliant with regulatory updates.

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