For Class C medical device registration with CDSCO in India, you need to follow these steps:
Preparation: Gather all required documents, including clinical data, technical documentation, manufacturing licenses, and ISO certifications.
Application Form: Submit the application form online through the CDSCO’s online portal (SUGAM).
Fees: Pay the applicable fees for registration.
Documentation: Upload all required documents and detailed information about the device, including its intended use, labeling, and risk management.
Review: CDSCO will review your submission. They may request additional information or documents.
Inspection: An inspection of the manufacturing site may be required.
Approval: Once everything is satisfactory, CDSCO will issue the registration certificate.
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