CDSCO Medical Device Products List by Class (Class A, B, C & D) Under Medical Device Rules, 2017

• CDSCO Medical Device Products List classifies all medical devices into 4 risk-based classes: A (lowest) to D (highest) under MDR 2017.
• As of 2026, over 50 categories of medical devices are notified and regulated under Schedule I of the Medical Device Rules, 2017.
• Every manufacturer and importer must obtain CDSCO registration/license before selling any notified medical device in India.
• Devices in Class C and Class D require mandatory clinical evaluation data along with regulatory submission.

What Is the CDSCO Medical Device Classification System?

If you are a medical device manufacturer, importer, distributor, or healthcare professional in India, understanding the CDSCO medical device products list by class is the single most important compliance step you need to take in 2026. The Central Drugs Standard Control Organization (CDSCO), operating under the Ministry of Health and Family Welfare, regulates all medical devices in India through the Medical Device Rules, 2017 (MDR 2017).

The classification framework divides medical devices into four distinct risk categories — Class A, Class B, Class C, and Class D — based on the intended use, duration of contact with the human body, degree of invasiveness, and potential risk to patients. This risk-based classification determines the level of regulatory scrutiny, documentation requirements, and the type of CDSCO license or registration a business must obtain.

CDSCO Medical Device Classification — Class A to D

The table below summarises all four risk classes, their risk profile, and typical device examples:

The regulatory pathway and documentation intensity increases significantly from Class A to Class D. Manufacturers or importers of Class D devices must submit clinical evaluation reports, post-market surveillance plans, and quality management system certificates.

Class A Medical Devices — Low-Risk Products List

Class A medical devices have a lowest risk to patients and users. These are non-invasive devices or devices with minimal body contact. Under MDR 2017, Class A devices require enrolment with the CDSCO portal (not a full license), making the compliance barrier lowest in this category. However, manufacturers must still maintain technical documentation, labelling compliance, and adverse event reporting obligations.

Complete List of Class A Medical Devices (CDSCO Notified, MDR 2017)

Note: Class A sterile devices (e.g., sterile wound dressings) require a higher level of conformity assessment and may be treated as Class B for registration purposes.

Class B Medical Devices — Low-to-Moderate Risk Products List (CDSCO)

Class B devices have a moderate interaction with the human body and carry a slightly elevated risk compared to Class A. These devices require a CDSCO Registration Certificate obtained from the Central Licensing Authority. Class B device manufacturers must submit a technical file demonstrating conformity with applicable Indian standards or equivalent international standards.

Complete List of Class B Medical Devices (CDSCO Notified, MDR 2017)

Manufacturers of Class B devices must hold a valid manufacturing license from the State Licensing Authority and a CDSCO registration before commercial sale or import. Imported Class B devices require an Import License (Form MD-15) from CDSCO.

Class C Medical Devices — Moderate-to-High Risk Products List (CDSCO)

Class C devices are moderate-to-high risk devices that have significant interaction with human tissue, blood, or critical body systems. These include active therapeutic devices, long-term implantable devices, and devices used in critical care settings. Class C medical devices require both State Manufacturing License and Central License (Form MD-9) from CDSCO. Importers must obtain an Import License in Form MD-15.

The technical documentation for Class C devices must include pre-clinical safety data, biocompatibility testing, electrical safety testing (for active devices), and performance testing. Post-market clinical follow-up (PMCF) plans are also required.

Complete List of Class C Medical Devices (CDSCO Notified, MDR 2017)

Class D Medical Devices — Highest Risk Products List (CDSCO)

Class D represents the most complex and highest-risk category of medical devices regulated by CDSCO. These are devices that sustain or support life, are implanted in the human body long-term, or are used in diagnostics of life-threatening conditions. The regulatory requirements for Class D devices are the most stringent — mandatory clinical investigation data, post-market surveillance studies, and in many cases, CDSCO-notified body conformity assessment.

Importers and manufacturers of Class D devices are required to demonstrate substantial equivalence or, in the absence of a predicate device, provide new clinical data. The CDSCO scrutinizes Class D device applications through its Expert Committee for Medical Devices before granting approval.

Complete List of Class D Medical Devices (CDSCO Notified, MDR 2017)

CDSCO Medical Device Registration & Licensing Process in India (Step-by-Step, 2026)

Whether you are a domestic manufacturer or an overseas company looking to import medical devices into India, here is the complete step-by-step CDSCO medical device registration process under MDR 2017 as it stands in 2026:

• Create an account on the CDSCO online portal: sugam.mohfw.gov.in — all applications are processed digitally.
• Determine the correct classification of your medical device (Class A, B, C, or D) as per Schedule III of MDR 2017.
• Prepare the technical documentation file including device description, intended use, standards compliance, risk analysis, biocompatibility data, and labelling.
• For Class C and Class D devices, prepare clinical evaluation reports (CER) and post-market surveillance (PMS) plans.
• For imported devices: appoint an Indian Authorized Agent and obtain a Free Sale Certificate / Certificate of Conformity from the country of origin.
• Pay the applicable application fee through the online portal.
• Submit the application online in the prescribed form (Form MD-14 for import registration / Form MD-3 for manufacturing license).
• Respond to CDSCO queries within the stipulated timeline — typically 30 to 90 working days depending on device class.
• If approved, CDSCO issues the Registration Certificate / Manufacturing License / Import License in digital format.
• Maintain post-market vigilance: report adverse events within 30 days of awareness (serious incidents within 10 days).

Who Needs to Register a Medical Device with CDSCO?

The Medical Device Rules, 2017 mandates regulatory action from the following entities:

• Indian Manufacturers producing any notified medical device for sale in India or for export.
• Importers bringing foreign-manufactured medical devices into India for commercial distribution.
• Authorized Indian Agents of overseas manufacturers who handle regulatory and post-market responsibilities in India.
• Contract Manufacturers producing devices on behalf of a brand owner for the Indian market.
• Re-labellers and Repackagers who modify the branding or packaging of registered devices.

Distributors and retailers are not required to obtain a CDSCO license but must ensure they deal only in devices covered by a valid CDSCO registration or license.

Documents Required for CDSCO Medical Device Registration

The documents required vary by device class. Here is a consolidated checklist:

CDSCO Medical Device Registration Fees (Updated for 2026)

Government fees for CDSCO medical device registration are determined by the Third Schedule of MDR 2017. Fees differ based on device class and application type. The figures below are indicative and based on the latest CDSCO fee schedule:

Note: Fees for small-scale manufacturers (SSI) and start-ups may be eligible for concessions. Always verify the current fee schedule on the CDSCO website (cdsco.gov.in) before making payment, as these are subject to revision.

Validity Period and Renewal Timeline for CDSCO Medical Device License

Failing to apply for renewal within the prescribed window may result in lapse of the registration, requiring fresh application. The CDSCO has been increasingly strict about post-market compliance as part of its regulatory maturation in 2025 and 2026.

Benefits of CDSCO Medical Device Registration for Manufacturers and Importers

Obtaining CDSCO registration for your medical device offers significant business and compliance advantages:

• Legal market access: Only CDSCO-registered or licensed devices can be legally sold, distributed, or imported in India.
• Consumer trust and credibility: CDSCO approval signals product safety, quality, and performance to healthcare professionals and procurement committees.
• Participation in government tenders: Most Central and State government procurement portals mandate CDSCO registration as a pre-qualification criterion.
• Eligibility for export: CDSCO registration and a Certificate to Foreign Government (CFG) are required for exporting devices from India to regulated markets.
• Protection from product bans: Registered devices are less likely to face arbitrary market bans or enforcement actions by State Drug Controllers.
• Investment attractiveness: CDSCO-compliant product portfolios attract private equity, strategic buyers, and institutional investors in the MedTech space.
• Alignment with global standards: The MDR 2017 framework is broadly harmonised with the IMDRF guidelines, making CDSCO-compliant documentation reusable for CE, FDA, or TGA filings.

Conclusion — Navigating the CDSCO Medical Device Classification System in 2026

Understanding the CDSCO medical device products list by class is not just a regulatory exercise — it is a strategic business imperative for anyone operating in India's fast-growing INR 90,000 crore medical devices sector. Whether you manufacture stethoscopes (Class A), blood glucose monitors (Class B), hip implants (Class C), or cardiac pacemakers (Class D), the regulatory pathway, timelines, fees, and documentation requirements vary significantly.

India's medical device regulatory framework under MDR 2017 has matured considerably since its implementation, with CDSCO strengthening post-market surveillance, expanding the notified device list, and progressively aligning with global standards like IMDRF, ISO, and IEC. Companies that invest early in regulatory strategy — building proper technical files, obtaining the right licenses, and maintaining post-market vigilance systems — are far better positioned to capture growth in this regulated market.

If you are unsure about the classification of your specific product, CDSCO offers a pre-submission meeting facility. Additionally, engaging a qualified Indian Regulatory Affairs consultant can significantly reduce approval timelines and avoid costly application deficiencies.

Frequently Asked Questions