The process for CDSCO registration of Class A medical devices in India includes:

1. Preparation:

   • Document Collection: Compile required documents such as product specifications, labeling, proof of compliance with quality standards (like ISO 13485), and clinical evidence if applicable.
   • Company Registration: Ensure your company is registered and has the necessary licenses to operate in India.

2. Application Submission:

   • Online Portal: Register and submit the application on the CDSCO online portal (SUGAM).
   • Application Form: Complete the form with details about the device, manufacturer, and intended use.
   • Fees: Pay the requisite application fee through the portal.

3. Review Process:

   • Document Verification: CDSCO reviews submitted documents for completeness and compliance.
   • Technical Evaluation: For Class A devices, the process is generally less rigorous compared to higher classes but still includes verification of safety and performance data.

4. Approval:

   • Certificate Issuance: Upon successful review, CDSCO issues a registration certificate, allowing the device to be marketed in India.

5. Post-Market Surveillance:

   • Compliance: Adhere to any post-market surveillance requirements and reporting of adverse events as stipulated by CDSCO.

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