Before applying for CDSCO registration of Class A medical devices, thorough preparatory work is essential to ensure a smooth and successful application process. Here are the key steps to undertake:

1. Understand Regulatory Requirements:

• Review Regulations: Familiarize yourself with the Medical Devices Rules, 2017, and any relevant CDSCO guidelines specific to Class A medical devices.
• Device Classification: Confirm that your device correctly falls under Class A based on its risk classification.

2. Prepare Technical Documentation:

• Device Description: Prepare a detailed description of the device, including its intended use, design, materials, and specifications.
• Labeling: Ensure that product labels and packaging meet CDSCO requirements, including information such as the device’s name, intended use, and instructions for use.

3. Establish Quality Management System:

• ISO Certification: Obtain ISO 13485 certification or an equivalent quality management system certification. Ensure your quality management system complies with the necessary standards.
• Document Processes: Prepare documentation on your manufacturing processes, quality control measures, and risk management practices.

4. Gather Required Documents:

• Manufacturing License: Obtain a valid manufacturing license from the relevant regulatory authority in the country of origin.
• Clinical Data: Collect any available clinical data or performance evidence, even though it is less stringent for Class A devices.

5. Appoint Authorized Representative (if applicable):

• Local Representation: If the device is manufactured outside India, appoint a local authorized representative or distributor in India. Ensure their details are ready for submission.

6. Prepare for Application Submission:

• Register on SUGAM Portal: Create an account on the CDSCO SUGAM portal, where the application will be submitted.
• Complete Application Form: Fill out the application form on the SUGAM portal with accurate and complete information.

7. Review and Verify Documents:

• Document Accuracy: Review all documents and ensure they are complete, accurate, and comply with CDSCO requirements.
• Internal Review: Conduct an internal review or audit to verify that all required documentation is prepared and in order.

8. Payment of Fees:

• Fee Structure: Understand the fee structure for registration and ensure you are prepared to pay the application fee online through the SUGAM portal.
• Proof of Payment: Keep proof of payment as it may be required during the submission process.

9. Plan for Post-Submission:

• Monitor Application Status: Be prepared to monitor the status of your application on the SUGAM portal and respond to any requests for additional information from CDSCO.
• Post-Market Surveillance: Develop a plan for post-market surveillance and reporting of any adverse events or issues related to the device.

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