How to apply for Class C medical device registration with CDSCO in India?
Release time:2024-08-29 14:50:52 The author: source:
Preparation: Gather all required documents, including clinical data, technical documentation, manufacturing licenses, and ISO certifications.

For Class C medical device registration with CDSCO in India, you need to follow these steps:

  1. Preparation: Gather all required documents, including clinical data, technical documentation, manufacturing licenses, and ISO certifications.

  2. Application Form: Submit the application form online through the CDSCO’s online portal (SUGAM).

  3. Fees: Pay the applicable fees for registration.

  4. Documentation: Upload all required documents and detailed information about the device, including its intended use, labeling, and risk management.

  5. Review: CDSCO will review your submission. They may request additional information or documents.

  6. Inspection: An inspection of the manufacturing site may be required.

  7. Approval: Once everything is satisfactory, CDSCO will issue the registration certificate.

louis-reed-JeInkKlI2Po-unsplash.jpg

Contact Us:

Whatsapp or Wechat:+86 15816864648;email address:hito.lin@grzan.cn