Classification of Medical Devices as per GSR 78(E)

Medical Devices Rules, 2017 (notified vide G.S.R. 78(E) dated 31st January 2017) marked a significant shift in India's regulatory framework for medical devices. These rules, which came into force on 1st January 2018, brought medical devices under structured regulation under the Drugs and Cosmetics Act, 1940. They introduced a risk-based classification system aligned with international standards (similar to IMDRF/GHTF guidelines).

The classification is detailed in Rule 4 and the First Schedule of the MDR 2017. It determines the level of regulatory scrutiny, documentation requirements, clinical data needs, and licensing pathway for manufacturing, import, sale, and distribution of medical devices in India.

Why Classification Matters

Classification is based on:

• Intended use of the device
• Degree of risk to the patient or user
• Invasiveness
• Duration of body contact (transient, short-term, long-term)
• Whether the device is active (powered) or passive
• Potential for harm if the device fails

Higher-risk classes require stricter controls, more extensive technical dossiers, possible site inspections, and clinical evidence. This system helps ensure patient safety while facilitating market access for low-risk devices.

The Central Licensing Authority (CLA) — the Drugs Controller General of India (DCGI) under CDSCO — is responsible for final classification. CDSCO publishes category-wise lists of devices with their assigned risk classes, which are dynamic and subject to periodic updates.

The Four Risk Classes under GSR 78(E)

Medical devices (other than In Vitro Diagnostics) are classified into four classes as per Part I of the First Schedule:

Note on In Vitro Diagnostic (IVD) Devices: IVDs follow a parallel classification under Part II of the First Schedule (also Class A to D), based on risk to the individual and public health (e.g., HIV tests often Class C or D).

Parameters for Classification (First Schedule Highlights)

The First Schedule provides detailed rules for assigning classes:

• Non-invasive devices → Generally Class A, but escalate if used on injured skin or for channeling/storing substances for infusion.
• Invasive devices → Class increases with duration of use and invasiveness (e.g., surgically invasive for short-term vs. long-term).
• Active devices (powered) → Classified based on energy delivery or diagnostic/therapeutic purpose.
• Special rules apply for devices like software, accessories, or those with medicinal substances.
• If multiple rules apply, the strictest rule (highest class) takes precedence.
• Accessories are classified independently.

Classification ultimately depends on the manufacturer's intended use statement. CDSCO maintains detailed lists by medical specialty (e.g., cardiovascular, orthopedic, radiology, oncology) on its website and portal.

Special Provisions for Class A Devices

In October 2022, the government issued GSR 777(E), exempting non-sterile and non-measuring Class A devices from the full import licensing regime. These devices only require:

• Mandatory registration on the CDSCO Medical Devices portal (cdscomdonline.gov.in).
• Self-certification and labeling compliance.

This has simplified market entry for many basic consumables while maintaining oversight.

Implications for Foreign Exporters and Manufacturers

• Class A (non-sterile/non-measuring): Easiest entry — quick registration.
• Class B, C, D: Require full Import License (Form MD-15) through an Indian Authorized Agent (IAA). Higher classes demand more documentation, Free Sale Certificate, and possibly clinical data from India.
• Devices approved in stringent regulatory jurisdictions (US, EU, Canada, Japan, Australia) often enjoy a simplified pathway with reduced clinical requirements.
• All devices must comply with labeling rules (Chapter VI) and post-market surveillance obligations.

Recent Developments (as of 2026): CDSCO continues to release updated risk classification lists for specific categories (e.g., oncology, nephrology, radiotherapy). A new online module for risk classification requests helps resolve ambiguities.

How to Determine the Class of Your Device

1. Review the First Schedule parameters.
2. Check the latest CDSCO-published classification lists for your device category.
3. If unclear, submit a classification query via the CDSCO portal.
4. Engage a regulatory consultant or experienced Indian Authorized Agent for complex cases.

Conclusion

The risk-based classification under GSR 78(E) — the Medical Devices Rules, 2017 — has modernized India's medical device regulatory ecosystem. It balances patient safety with ease of doing business, encouraging innovation and imports while aligning India closer to global harmonized standards.

Whether you are a foreign exporter, domestic manufacturer, or distributor, correctly identifying your device's class is the first and most critical step for compliant market entry.

Official Resources:

• Full Medical Devices Rules, 2017 (and amendments) on cdsco.gov.in
• Medical Devices Portal: cdscomdonline.gov.in
• Latest classification lists and notices on the CDSCO website

For device-specific classification or assistance with import licensing, provide details of your product (intended use, specifications, category), and regulatory experts can guide you precisely. Always verify the most current notifications, as the lists are periodically updated.

Last Updated : 30 Apr 2026