The process for CDSCO registration of Class A medical devices involves several key steps. Here’s a detailed guide to the registration process:

1. Determine Device Classification:

• Confirm Classification: Ensure that your device qualifies as a Class A medical device based on its risk classification as defined by the Medical Devices Rules, 2017. Class A devices are considered low risk.

2. Prepare Documentation:

• Technical File: Compile a comprehensive technical file, including:
  • Device description and intended use
  • Design and development information
  • Performance and safety data
  • Labeling and packaging information
  • Quality management system documentation
• ISO Certification: Obtain ISO 13485 certification or an equivalent quality management system certification.
• Manufacturing License: Prepare a copy of the manufacturing license or certificate from the regulatory authority in the device’s country of origin.

3. Register on SUGAM Portal:

• Create Account: Register on the CDSCO SUGAM portal, which is the official platform for submitting applications and managing registration processes.
• Submit Application: Fill out and submit the application form on the SUGAM portal. Provide all required details and attach the prepared documentation.

4. Pay Fees:

• Application Fee: Pay the applicable registration fee online through the SUGAM portal. The fee amount depends on the type and classification of the device.
• Proof of Payment: Keep a record of the payment confirmation as it may be needed for submission or verification.

5. Review and Verification:

• Application Review: CDSCO will review the submitted application and documentation. They may request additional information or clarifications if needed.
• Documentation Verification: Ensure that all documentation is accurate, complete, and compliant with CDSCO requirements.

6. Inspection (if required):

• Facility Inspection: CDSCO may conduct an inspection of the manufacturing facility, especially if the device is imported. Ensure that the facility meets regulatory standards and is prepared for the inspection.

7. Approval and Issuance:

• Registration Certificate: Once the application is approved, CDSCO will issue a registration certificate for the Class A medical device.
• Certification Details: Review the registration certificate and ensure that all details are correct. This certificate will be valid for a specified period, after which renewal is required.

8. Post-Registration Requirements:

• Post-Market Surveillance: Implement a system for monitoring the device’s performance in the market. Report any adverse events or issues to CDSCO.
• Renewal and Amendments: Be aware of renewal deadlines and apply for amendments if there are significant changes to the device or its documentation.

9. Compliance with Regulations:

• Regulatory Updates: Stay informed about any changes in regulations or requirements from CDSCO. Ensure ongoing compliance with all relevant standards and guidelines.

Summary of Steps:

1. Determine Device Classification: Confirm Class A status.
2. Prepare Documentation: Technical file, ISO certification, manufacturing license.
3. Register on SUGAM Portal: Create account and submit application.
4. Pay Fees: Complete payment and keep proof.
5. Review and Verification: Address any additional information requests.
6. Inspection (if required): Prepare for and undergo facility inspection.
7. Approval and Issuance: Obtain registration certificate.
8. Post-Registration Requirements: Implement post-market surveillance and manage renewals and amendments.
9. Compliance with Regulations: Monitor and adhere to regulatory updates.

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