NEW IVD

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Lateral flow test held beside the CDSCO in vitro diagnostic portal showing the new IVD regulatory framework and pathway in India

In India, the form for obtaining permission to import or manufacture a new In-Vitro Diagnostic (IVD) medical device is MD-28. Here’s an overview of the process and related forms:

Key Forms

  • MD-28: The application form submitted to the Central Licensing Authority (CLA) seeking permission to import or manufacture a new IVD.
  • MD-29: The permission letter issued by the CLA, granting approval for importing or manufacturing the new IVD.

The Application Process

  • Clinical Performance Evaluation (if required): For new IVDs without a predicate device, clinical performance studies might be needed. You may need to apply for Form MD-24 to get permission for the study and Form MD-25 for protocol approval.
  • MD-28 Submission: Submit the MD-28 application through the Sugam portal, along with:
    • Device information (classification, intended use, etc.)
    • Technical documentation
    • Clinical performance evaluation data (if applicable)
    • Manufacturing details
    • Certifications (like ISO 13485 for your quality management system)
    • Declarations and proofs
  • CDSCO Review: The CDSCO reviews the application and supporting documents.
  • MD-29 Issuance: If the application is approved, the CLA grants permission in the form of MD-29.

Additional Notes

  • The process can vary slightly depending on the specific IVD device and its classification.
  • The CDSCO website (https://cdsco.gov.in/opencms/opencms/en/Home/), has further details and guidance documents.
  • It’s recommended to seek assistance from a regulatory consultant specializing in Indian medical device and IVD regulations, as the process can be complex.

MD-28 Form Structure

The exact structure of the MD-28 form can be found on the CDSCO’s SUGAM portal, but here’s the general type of information it typically requests:

  • Part I: Applicant and Device Information
    • Applicant/Manufacturer Details: Name, address, manufacturing license/wholesale license details, authorized Indian agent details.
    • Device Details: Device name, classification, intended use, whether predicate devices exist domestically and internationally, etc.
  • Part II: Technical Documentation
    • Design and Manufacturing Information: Detailed drawings, materials list, specifications, manufacturing process description.
    • Performance and Safety Data: Results of performance testing, analytical and clinical validation data, risk analysis, stability studies.
    • Labeling: Specimen/product labels, instructions for use, list of symbols used.
  • Part III: Clinical Performance Evaluation (if applicable)
    • Study Protocol: If a clinical study was conducted, the detailed protocol would be included.
    • Study Report: Comprehensive report summarizing the study results, data, and conclusions on safety and performance.
  • Part IV: Quality Management System
    • Quality certificates: ISO 13485 or equivalent for the manufacturing facility.
    • Process Validation: Documented validation of key manufacturing processes.
  • Part V: Additional Declarations and Information
    • Declarations of conformity to standards.
    • Undertakings regarding post-market vigilance.
    • Proof of fee payment.

Key Considerations

  • Data Quality: The success of your application depends heavily on the quality of the data you provide. Ensure your device testing, clinical studies (if applicable), and documentation are rigorous and well-organized.
  • Regulatory Classification: IVD devices are classified based on risk. This will influence the level of data required. Consult CDSCO guidance or a regulatory specialist to understand your IVD’s classification.
  • Predicate Devices: If a similar IVD (predicate device) already exists in India or internationally, include detailed information for comparison, potentially simplifying the process.

Guidance Resources

  • CDSCO Website: The CDSCO website (https://cdsco.gov.in/opencms/opencms/en/Home/) has relevant guidance documents.
  • Medical Device Rules, 2017: Search for guidance specific to IVDs.

Professional Assistance

Due to the complexity of the process, and especially if your IVD is high-risk or entirely novel, consider working with a regulatory affairs consultant who specializes in the Indian market. They’ll guide you through:

  • Compiling documentation
  • Ensuring data meets CDSCO standards
  • Optimizing the application strategy

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