How to Determine the Right CDSCO Risk Class for Your Medical Device Under MDR 2017

Correctly identifying the risk class of a medical device is one of the most important early steps for any manufacturer or importer planning to enter or operate in the Indian market. Under the Medical Devices Rules, 2017 (MDR 2017), the Central Drugs Standard Control Organisation (CDSCO) follows a clear risk-based classification system. Getting this step right determines licensing requirements, documentation depth, timelines, fees, and post-market obligations. Getting it wrong can lead to application rejection, delays, or non-compliance issues.

Understanding CDSCO Classification Under MDR 2017

The Medical Devices Rules, 2017 classify medical devices (other than in vitro diagnostic devices) into four classes based on parameters given in Part I of the First Schedule:

• Class A medical devices – Low risk
• Class B medical devices – Low-moderate risk
• Class C medical devices – Moderate-high risk
• Class D medical devices – High risk

In vitro diagnostic (IVD) medical devices follow a parallel four-class system using parameters in Part II of the First Schedule.

Classification depends primarily on the device’s intended use, duration of contact with the body, degree of invasiveness, whether it is active or non-active, and the potential risk to the patient or user if the device fails. The Central Licensing Authority (CDSCO) is responsible for classifying devices and publishes class-wise lists on its website. These lists are dynamic and may be updated with additions, deletions, or modifications of class from time to time.

Importantly, manufacturers and importers do not independently assign the final class in the same way as under some other jurisdictions. While the First Schedule provides the classification rules (aligned with international principles such as those from IMDRF), the authoritative class for a specific device type is the one published by CDSCO or confirmed through the official process.

How to Find the Correct Classification for Your Device

Follow these practical steps to determine the accurate class:

1. Confirm it is a medical device
   Check whether your product falls under the definition notified under the Drugs and Cosmetics Act (as expanded by S.O. 648(E) dated 11 February 2020 and subsequent notifications). The definition covers instruments, apparatus, appliances, implants, materials, software, or accessories intended for specific medical purposes that do not achieve their primary action by pharmacological, immunological, or metabolic means.
2. Review the published CDSCO classification lists
   CDSCO regularly releases and updates lists of medical devices and IVDs with their assigned risk classes and general intended use statements. Search the official CDSCO website for the latest classification documents covering various categories (surgical, diagnostic, orthopaedic, oncology, software, etc.). Match your device’s intended use and description as closely as possible to the listed entries.
3. Apply the First Schedule parameters if the device is not listed
   If your device does not appear in any published list, examine the classification rules in Part I (or Part II for IVDs) of the First Schedule. Key factors include:
   • Non-invasive vs. invasive (body orifice or surgically invasive)
   • Duration of use (transient, short-term, or long-term)
   • Contact with injured skin, body fluids, or critical systems
   • Whether the device is active (powered) and its therapeutic or diagnostic function
   • Special features such as incorporation of medicinal substances or animal-origin materials
4. Use the official online Risk Classification Module (for non-IVD devices)
   Since late 2025, CDSCO has operationalised a Risk Classification Module on the CDSCO Online System for Medical Devices (cdscomdonline.gov.in). Applicants can submit a request for risk classification of devices not already listed. This provides an official determination before filing a full licence application and reduces uncertainty.
5. Consider grouping if applicable
   Under Rule 5 of MDR 2017 and the associated grouping guidelines, devices may be grouped as a single device, family, system, group, IVD test kit, or IVD cluster when they share the same licence holder, risk class, and other defined criteria. Correct grouping can streamline applications but does not change the underlying risk class of individual devices.
6. Document the rationale thoroughly
   Record the intended use statement, comparison with published lists, application of First Schedule rules, and any official confirmation received. This documentation supports the technical file and any future queries from the licensing authority.

Why Accurate Classification Matters

Correct classification directly influences:

• Whether manufacturing of Class A and B devices is handled primarily by the State Licensing Authority or Class C and D by the Central Licensing Authority
• The need for Notified Body audit of the quality management system
• Depth of technical documentation and clinical evidence required
• Licence type (registration vs. manufacturing/import licence)
• Post-market surveillance and adverse event reporting intensity
• Applicable fees and processing timelines

Misclassification can result in incomplete applications, requests for additional data, or the need to restart the process under a different class. For higher-risk devices (Class C and D), the pathway is more rigorous, often involving greater scrutiny of design, risk management, and clinical performance.

Common Challenges and Practical Tips

Many applicants face difficulty when a device has multiple intended uses, novel technology, or software components (including Medical Device Software). In such cases, the highest applicable risk class usually governs. Software that drives or influences a hardware device generally takes the same class as the parent device.

Always use the most recent published lists and guidance documents available on the CDSCO website. Classification lists are living documents; periodic checks are essential. For borderline or innovative products, the online risk classification module or formal clarification from CDSCO is the safest route.

Why Choose MDR Consultants for Your Classification and Compliance Journey

Navigating CDSCO classification and the full MDR 2017 pathway requires both regulatory knowledge and practical experience with application preparation, technical documentation, and interaction with authorities. At MDR Consultants we specialise in helping manufacturers and importers accurately determine device class, prepare robust submissions, manage grouping strategies, and achieve timely regulatory compliance.

Our team stays updated with the latest circulars, classification lists, and portal functionalities so that your classification decision is correct the first time. Whether you are registering a low-risk Class A device or seeking licence approval for a high-risk Class D implant, we provide end-to-end support tailored to the Indian regulatory framework. Choosing experienced consultants reduces risk of delays, rejections, and unnecessary costs while ensuring your product reaches the market with full compliance confidence.

Conclusion

Finding the correct CDSCO classification for your medical device under the Medical Devices Rules, 2017 is a foundational regulatory step that shapes the entire compliance pathway. Start by confirming the product definition, thoroughly review the published class-wise lists, apply the First Schedule parameters where needed, and utilise the official online risk classification facility for unlisted devices. Accurate classification protects patient safety, streamlines licensing, and supports long-term market access in India.

If you need assistance determining the precise class of your device, preparing supporting documentation, or managing the full registration or licensing process, MDR Consultants is ready to help. Reach out to our team for clear, guideline-aligned guidance that keeps your project on track and fully compliant with current CDSCO requirements.

Last Updated : 07 Sep 2026