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What is the CDSCO registration for Class A medical devices in India? How to apply?
Release time：2024-08-27 11:09:58 The author: source:
Prepare Documentation: Gather required documents including a product description, labeling information, and proof of compliance with ISO standards or equivalent.

For Class A medical devices in India, CDSCO registration involves the following steps:

  1. Prepare Documentation: Gather required documents including a product description, labeling information, and proof of compliance with ISO standards or equivalent.

  2. Submit Application: File an application through the CDSCO online portal, including all necessary documents and a fee.

  3. Evaluation: CDSCO reviews the application. For Class A devices, this process is generally less stringent compared to higher-risk classes.

  4. Approval: If the application is approved, you receive a registration certificate.

Ensure compliance with specific guidelines from CDSCO for Class A devices to streamline the process.

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