To obtain CDSCO registration for Class A medical devices in India, you must meet the following requirements:

1. Company Requirements:

• Company Registration: Ensure that your company is legally registered and compliant with Indian laws.
• Manufacturing License: Provide evidence of a valid manufacturing license from the relevant regulatory authority in the country of origin.

2. Product Documentation:

• Product Description: Detailed description of the medical device, including its intended use, design, and specifications.
• Labeling Information: Information as per Indian labeling requirements, including instructions for use, indications, contraindications, and safety warnings.
• Device Classification: Proof that the device is correctly classified as a Class A device based on its risk profile.
• Compliance with Standards: Proof of compliance with relevant ISO standards, such as ISO 13485 (Quality Management Systems).

3. Technical Documentation:

• Design and Manufacturing Details: Documentation of the design, development, and manufacturing processes.
• Clinical Evidence (if applicable): While Class A devices generally require less clinical evidence, provide any relevant data demonstrating safety and performance if requested.

4. Application Form:

• Complete Application Form: Fill out the application form accurately on the CDSCO online portal (SUGAM), including all required details about the device and manufacturer.

5. Fees:

• Application Fee: Pay the requisite registration fee through the CDSCO online portal. The fee amount depends on the type and number of devices being registered.

6. Compliance with Indian Regulations:

• Manufacturing Practices: Ensure that the manufacturing practices meet Indian regulations and standards.
• Quality Assurance: Demonstrate that your device adheres to quality assurance practices.

7. Local Agent (if applicable):

• Authorized Representative: If the manufacturer is based outside India, appoint a local authorized representative or distributor in India who will be responsible for compliance with CDSCO regulations.

8. Post-Market Obligations:

• Adverse Event Reporting: Be prepared to comply with post-market surveillance requirements, including the reporting of any adverse events or device defects.

Submission Process:

1. Online Application: Register and submit your application via the CDSCO online portal (SUGAM).
2. Document Upload: Upload all required documents and forms as part of the application process.
3. Fee Payment: Complete the payment of the application fee through the portal.

By ensuring that you meet all these requirements, you can facilitate a smoother registration process for Class A medical devices with CDSCO.

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