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Indian Medical Device and IVD Vigilance Database

 Welcome to the Indian Medical Device and IVD Vigilance Database

This platform is an initiative aimed at promoting transparency, accountability, and continuous improvement in the healthcare industry by facilitating the collection and analysis of vigilance data related to medical devices and in vitro diagnostic (IVD) devices. Our primary focus is on manufacturers and importers approved by the Central Drugs Standard Control Organization (CDSCO).

Objectives:

  • Data Collection: Gather vigilance reports from users to build a robust repository of incidents associated with medical devices and IVDs in India.
  • Research and Analysis: Enable manufacturers to analyze collected data for Post-Market Surveillance (PMS), clinical studies, and other relevant regulatory requirements.
  • Enhance Safety: Provide a platform for identifying and mitigating risks associated with medical devices and IVDs, ensuring patient safety.
  • Regulatory Support: Assist in the generation of reports that support compliance with national and international standards.
  • Stakeholder Engagement: Foster collaboration between healthcare professionals, manufacturers, and regulatory bodies to address emerging challenges in medical device safety.

Vigilance Data Dashboard

Search by MFG/IMP License Number to review vigilance data for research purposes.

How to Use This Database

Using the Indian Medical Device and IVD Vigilance Database is simple and user-friendly. Start by entering a valid CDSCO-issued license number in the search bar provided. The license number must follow one of the approved formats: MFG/MD/YYYY/000000, MFG/IVD/YYYY/000000, IMP/MD/YYYY/000000, or IMP/IVD/YYYY/000000. Once a valid license number is entered, the system will retrieve and display relevant vigilance data associated with that license, including reported incidents and brief overviews.

If the entered license number does not match the approved format, an error message will be displayed. Please verify the license number and try again. For each entry, you can view detailed, date-wise information about reported incidents by clicking the "View" button. This feature provides valuable insights for research, analysis, and generating regulatory reports.



Disclaimers:

  • The information provided on this platform is for research and educational purposes only.
  • This database is a pilot project and does not substitute formal regulatory reviews or decisions by CDSCO or other competent authorities.
  • All vigilance data submitted is subject to review and validation before inclusion in the database.
  • The creators of this platform are not liable for any misinterpretation or misuse of the data presented.

Terms and Conditions:

  • Submission of Data: Users submitting vigilance reports must ensure the accuracy and reliability of the information provided. Reports submitted must not contain false, misleading, or defamatory content.

  • Data Validation: 

    All license numbers entered will be validated against the CDSCO database. The platform reserves the right to reject submissions that fail to meet the required validation criteria.

  • Use of Data: 

    Data collected will be anonymized and used solely for research, analysis, and regulatory support purposes. The data may be shared with regulatory authorities or other stakeholders for public safety purposes.

  • Pilot Initiative: 

    This is a pilot project subject to updates and enhancements. Features and functionalities may change over time to improve usability and compliance.

  • User Responsibility: 

    By using this platform, users agree to comply with all applicable laws and regulations. Users are solely responsible for ensuring the correct use of the platform’s features.

Source of Information for the Vigilance Database

The data and information presented in this vigilance database are primarily sourced from the monthly list of spurious drugs published by the Central Drugs Standard Control Organization (CDSCO). According to Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is considered spurious if:

  1. It is manufactured under a name that belongs to another drug.
  2. It imitates, substitutes, or resembles another drug in a way that is likely to deceive consumers, or if its label or container bears the name of another drug without plainly and conspicuously marking its true character and lack of identity.
  3. The label or container falsely names an individual or company as the manufacturer, where such an individual or company is fictitious or non-existent.
  4. It is wholly or partially substituted with another drug or substance. 
  5. It falsely claims to be the product of a specific manufacturer when it is not.

To regulate medical devices and apply all relevant provisions, medical devices are included under the definition of drugs and are referred to as drugs under the Drugs and Cosmetics Act, 1940. The implementation and regulation of medical and in-vitro diagnostic (IVD) devices are predominantly governed by the Medical Device Rules, 2017.

This database consolidates such critical information to enhance transparency and promote regulatory vigilance by enabling stakeholders to track and report spurious drug and medical device cases effectively.

Join Us in Shaping the Future of Medical Device Vigilance

We invite healthcare professionals, manufacturers, and stakeholders to contribute to this initiative by submitting vigilance data, sharing feedback, and supporting this endeavor to enhance the safety and efficacy of medical devices and IVDs in India.