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January 3, 2025
Approximately 5 minutes
India IVD Device Registration: Classification, Import License (MD-15), and Local Testing
India IVD Device Registration and Approval
The regulation of In-Vitro Diagnostic (IVD) medical devices in India is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. These rules establish a risk-based classification system for IVD devices, requiring most kits to obtain an Import License (MD Form 15) prior to importation.
⚙️ IVD Classification and Fees
IVD devices are classified into four risk classes (A, B, C, D). The classification determines the application complexity and associated processing fees.
| Classification Type | Plant Master File (PMF) Fee (USD) | Device Master File (DMF) Fee (USD) | Authorization Pathway |
|---|---|---|---|
| Class A IVD (Non-M/S) | N/A (Exempt) | N/A (Exempt) | Registration/Listing Only (No Cost) |
| Class A IVD (Sterile/Measuring) | $1,000 | $10 | MD-15 Import License |
| Class B IVD | $1,000 | $10 | MD-15 Import License |
| Class C IVD | $3,000 | $500 | MD-15 Import License |
| Class D IVD | $3,000 | $500 | MD-15 Import License |
The processing time for Import License applications (MD-15) is typically 6 to 9 months. Licenses are valid in perpetuity but require retention fees every five years.
📑 Technical Documentation Requirements
Registration for imported IVDs (Classes A Sterile/Measuring, B, C, D) requires the submission of a Device Master File (DMF) and a Plant Master File (PMF) to the CDSCO, along with key supporting documents:
- Proof of Reference Country Approval: Documentation of approval from a recognized reference country (e.g., USA, EU, UK, Japan).
- ISO 13485 Certification: Mandatory certification of the manufacturing facility's Quality Management System (QMS) is required as part of the PMF.
🧪 Mandatory Local Performance Evaluation
For high-risk IVD devices and test kits targeting specific life-threatening diseases, a mandatory Performance Evaluation Report is required from a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory.
This requirement applies to kits related to diseases such as:
- HIV, Hepatitis B Virus (HBV).
- Blood Grouping Reagents.
- Tuberculosis, Malaria, Dengue, Chikungunya.
- Sexually Transmitted Agents and other life-threatening infections.
The performance evaluation must be submitted as part of the comprehensive registration application to the CDSCO.
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