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February 1, 2025
Approximately 5 minutes
India Medical Device Classification: Risk-Based System under Medical Devices Rules 2017
India Medical Device Classification System
The Central Drugs Standard Control Organization (CDSCO) in India employs a risk-based classification system for medical devices and In-Vitro Diagnostics (IVDs), as defined by the Medical Devices Rules, 2017 (MDR 2017). This classification is crucial as it determines the regulatory pathway, documentation requirements, and timeline for market authorization.
📈 Risk-Based Classification (Class A to D)
Medical devices are classified into four classes based on their intended use, level of risk, delivery method, and degree of invasiveness to the human body. The risk level ranges from low (Class A) to high (Class D).
| Classification | Risk Level | Authorization Requirement |
|---|---|---|
| Class A | Low | Online Registration/Self-Certification (Non-Measuring/Non-Sterile) or Import License (Measuring/Sterile) |
| Class B | Low-Moderate | Import License (MD-15) |
| Class C | Moderate-High | Import License (MD-15) |
| Class D | High | Import License (MD-15) |
As of October 1, 2023, all medical devices, including Class A (Measuring/Sterile), Class B, Class C, and Class D, are required to obtain an Import License before being imported and sold in India.
categorizing Products
The CDSCO classification process begins by grouping devices into 24 distinct product categories, which are more specific than standard global groupings. These categories include:
- Surgical Specialties: Cardiovascular, Neurological, Ophthalmic, etc.
- General Devices: General Hospital/Operation Theater (OT), Respiratory, Personal Use.
- IVD Devices: IVD products are categorized separately into IVD Analyzer, IVD Instrument, and IVD Software, and then further assigned a risk class (A-D).
The specific classification (A, B, C, or D) is determined within these categories based on the product’s detailed intended use and mechanism.
Regulatory Transition
The Indian regulatory system has been undergoing a mandatory transition, expanding the scope of devices that require registration and an Import License. This ensures all medical devices fall under the regulatory umbrella of the Drugs and Cosmetics Act of 1940. The CDSCO maintains a list of Notified Medical Devices that must comply immediately, but the mandate now covers virtually all device types.
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