To apply for CDSCO registration of Class A medical devices in India, you must meet several key conditions:

1. Company Requirements:

• Legal Registration: Your company must be legally registered and compliant with Indian laws.
• Manufacturing License: If the device is manufactured in India, your company must have a valid manufacturing license from the relevant Indian authority. If the device is imported, you must have an import license.

2. Product Requirements:

• Device Classification: Ensure that the device is correctly classified as a Class A medical device based on its risk profile.
• Product Description: Provide a detailed description of the device, including its intended use, design, and specifications.

3. Technical Documentation:

• Quality Management System: Proof of compliance with ISO 13485 or equivalent quality management system standards is required. This certification should be current and relevant to the device.
• Manufacturing Details: Documentation of the manufacturing process and facility, including quality control and assurance practices.
• Clinical Data: While less stringent for Class A devices, provide any available clinical evidence or performance data if relevant.

4. Documentation Preparation:

• Labeling: Ensure that labeling meets Indian regulatory requirements, including instructions for use, warnings, and any other required information.
• Certificates of Compliance: Include relevant certificates such as ISO certifications and any other applicable compliance documents.

5. Authorized Representative:

• Local Representation: 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.

6. Application Process:

• Complete Application Form: Accurately complete the application form on the CDSCO SUGAM portal.
• Document Submission: Upload all required documents to the SUGAM portal.
• Fee Payment: Pay the requisite registration fee online through the portal.

7. Compliance with Indian Regulations:

• Regulatory Compliance: Ensure the device and its manufacturing practices comply with Indian regulations and standards.
• Post-Market Obligations: Be prepared to comply with post-market surveillance requirements, including reporting adverse events.

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