CDSCO MD-15 Registration for Class A, B, C & D Medical Devices: Complete 2026 Guide

• MD-15 is the CDSCO import license required to legally import medical devices into India under the Medical Device Rules, 2017.
• It applies separately to Class A, B, C, and D devices, with fees and documentation increasing by risk class.
• Foreign manufacturers must apply through an Indian Authorized Agent holding a valid wholesale license.
• The license generally continues indefinitely if the retention fee is paid every 5 years on the SUGAM portal.

Introduction

CDSCO MD-15 Registration is the import license issued by India's Central Drugs Standard Control Organization (CDSCO) that allows a company to legally import medical devices into India. Whether your device falls under Class A, B, C, or D under the Medical Device Rules, 2017, you generally need this license before the product can be sold or distributed in India.

The application is filed on Form MD-14 through the SUGAM portal by an Indian Authorized Agent, and CDSCO grants the license on Form MD-15 after document review and, where required, a facility inspection. Fees, documentation, and approval timelines rise with the device's risk class, so getting the classification right at the start is the single most important step in the entire process.

What Is CDSCO MD-15 Registration?

MD-15 is the formal import license granted by the Central Licensing Authority (CLA) under CDSCO. It is the legal document that lets an importer bring a medical device manufactured outside India into the Indian market. The supporting application for this license is filed in Form MD-14; once CDSCO approves it, the license itself is issued in Form MD-15. Both forms exist under the Medical Device Rules (MDR), 2017, which replaced the older drug-based framework for devices.

Without a valid MD-15 license, customs authorities can seize imported devices, and the importer and Indian agent can face action under the Drugs and Cosmetics Act, 1940. This makes MD-15 a non-negotiable compliance requirement for any foreign manufacturer or Indian importer dealing in regulated devices.

Who Needs MD-15 Registration?

• Foreign manufacturers who want to sell, stock, or distribute medical devices in India through an Indian agent.
• Indian importers and distributors bringing in finished devices from overseas factories.
• Companies importing Class A (sterile or measuring), Class B, Class C, or Class D devices — Class A devices that are both non-sterile and non-measuring are currently exempt and follow a simplified self-registration route instead.
• Indian Authorized Agents (IAA) who act on behalf of the overseas manufacturer and must themselves hold a valid wholesale license registration (Form 41/42).

CDSCO Medical Device Classification: Class A, B, C, D

Under MDR 2017, CDSCO classifies every medical device into one of four risk-based categories. The classification determines which forms apply, how much the license costs, how long approval takes, and what documentation is needed. Lower classes (A) carry lower risk and lighter requirements; higher classes (C and D) carry higher risk and stricter scrutiny, including a higher likelihood of facility inspection.

Always confirm your device's exact class against CDSCO's official classification lists on the SUGAM/CDSCO MD Online portal before filing — misclassification is one of the most common reasons applications are delayed or rejected.

MD-15 Registration for Class A Medical Devices

Class A covers the lowest-risk devices. Sterile Class A devices and measuring Class A devices require the full MD-15 import license. Class A devices that are both non-sterile and non-measuring are exempt from MD-15 and instead go through a simplified Class A self-registration on the CDSCO portal — no government license fee applies to that exempt route.

• Examples (illustrative, confirm against your product): Examples commonly cited in this class:
• Non-sterile bandages and dressings (exempt, self-registration route)
• Sterile surgical instruments (MD-15 required)
• Digital thermometers and similar measuring devices (MD-15 required)

MD-15 Registration for Class B Medical Devices

Class B devices require full MD-15 registration in all cases. Documentation requirements are higher than the Class A exempt route, and the government fee is correspondingly higher.

• Examples commonly cited in this class: Hypodermic needles and syringes
• Suction equipment
• Diagnostic ultrasound devices (device-dependent — confirm exact sub-class)

MD-15 Registration for Class C Medical Devices

Class C devices are moderate-to-high risk. CDSCO typically requires more detailed technical files and may schedule a facility inspection before granting the license.

• Examples commonly cited in this class: Ventilators
• Bone fixation devices
• Certain diagnostic imaging equipment

MD-15 Registration for Class D Medical Devices

Class D covers the highest-risk devices, generally implantable or life-sustaining products. These applications face the strictest CDSCO review, the longest timelines, and the highest fees, and inspections are common.

• Examples commonly cited in this class: Cardiac stents and drug-eluting stents
• Heart valves
• Implantable pacemakers and similar implants

Eligibility for MD-15 Registration

• The applicant must be an Indian entity — a foreign manufacturer cannot file directly with CDSCO.
• Foreign manufacturers must appoint an Indian Authorized Agent (IAA) through a notarized Power of Attorney.
• The Indian Authorized Agent must hold a valid wholesale drug licenze (Form 20B/21B) or a registration certificate (Form 41/42).
• The device must be correctly classified under MDR 2017 (Class A, B, C, or D) before filing.
• The manufacturer must hold a valid manufacturing license or equivalent authorization in its country of origin, along with a Free Sale Certificate (FSC).

Documents Required for MD-15 Registration

• Power of Attorney (PoA) — notarized and apostilled or embassy-attested, authorizing the Indian agent
• Free Sale Certificate (FSC) / Certificate to Foreign Government — generally not older than 12 months at filing
• Device Master File (DMF) — device design, materials, sterilization method, risk analysis, shelf life
• Plant Master File (PMF) — site layout, equipment, utilities, and quality management system details
• ISO 13485 certification (or equivalent QMS evidence) for the manufacturing site
• Wholesale license registration (Form 41/42) of the Indian Authorized Agent
• Labelling, Instructions for Use (IFU), and proposed Indian labelling aligned with MDR 2017
• Stability/shelf-life data (for sterilized devices) and clinical evidence where applicable
• Manufacturer's business license / proof of legal manufacturing authorization in the country of origin

CDSCO MD-15 Registration Process: Step by Step

Classify the device correctly as Class A, B, C, or D using CDSCO's official classification list.

• Appoint an Indian Authorized Agent who holds a valid wholesale license and execute a notarized, attested Power of Attorney.
• Register on the SUGAM portal (sugam.gov.in) and complete the agent and manufacturer profile.
• Compile the Device Master File, Plant Master File, FSC, ISO 13485 certificate, and labelling documents.
• File the application on Form MD-14 with all supporting documents uploaded to SUGAM.
• Pay the prescribed government fee online (commonly through Bharatkosh) and upload payment proof.
• Respond promptly to any CDSCO queries raised during document review.
• Undergo a facility inspection if required, particularly for Class C and D devices.
• Receive the import license on Form MD-15 once CDSCO is satisfied with the application.
• Maintain post-market surveillance, labelling compliance, and pay the license retention fee every 5 years.

CDSCO MD-15 Registration Fees (Class-Wise)

Fee figures for CDSCO/MD-15 vary somewhat across published sources and are revised periodically by the government. The figures below reflect commonly cited ranges; always verify the current fee on the official SUGAM/CDSCO portal or directly with CDSCO before budgeting your application.

Additional notes: some published guidance also expresses Class A/B site fees around ₹83,300 and Class C/D site fees around ₹2,49,900, with an additional ~USD 1,000 per device — the wide variation across sources is precisely why confirming the live fee schedule on the portal before filing matters.

MD-15 Registration Timeline

Most sources place the overall MD-15 approval timeline between 3 and 9 months from submission to license grant, depending on device class, completeness of documentation, and whether a facility inspection is required.

MD-15 Validity, Retention, and Renewal

• Most current CDSCO guidance describes the MD-15 license as continuing indefinitely, provided the license retention fee is paid every 5 years from the date of issue.
• If the retention fee is not paid within the stipulated period, the license is deemed cancelled, and the import authorization lapses.
• If a license is cancelled for non-payment, the importer may have to repeat the entire registration process from scratch.
• Renewal/retention is processed through the SUGAM portal with updated documentation and the prescribed fee.
• The licence is specific to the importer and the named product(s) — it cannot be transferred to another company, and each new importer of the same device needs its own MD-15 licence.

Compliance After Getting MD-15 Registration

• Maintain labelling and Instructions for Use in line with MDR 2017 requirements.
• Run a post-market surveillance (PMS) programme to track device performance after sale.
• Keep import and distribution records for CDSCO inspection or audit purposes.
• Report adverse events or quality issues to CDSCO as required.
• Pay the retention fee on time every 5 years to keep the license active.

Penalties for Importing Without MD-15 Registration

• Devices can be seized at customs and denied entry into India.
• The importer and Indian Authorized Agent can face penalties and legal proceedings under the Drugs and Cosmetics Act, 1940.
• Repeat or serious violations can affect future license applications and business reputation in India.

Common Mistakes That Delay MD-15 Approval

• Filing a higher-risk device under a lower class to reduce fees — this is detectable and can force a restart with a flag on the application history.
• Submitting an expired Free Sale Certificate (CDSCO generally rejects FSCs older than 12 months).
• Missing embassy attestation when the manufacturer's country is not part of the Hague Apostille Convention.
• Missing CDSCO query response deadlines on the SUGAM portal, which can cause the application to be treated as abandoned.
• Inconsistent device details (model name/number, shelf life) across the DMF, PMF, FSC, and labelling.

Conclusion

• MD-15 is mandatory for importing Class A (sterile/measuring), B, C, and D medical devices into India.
• Correct device classification drives fees, documentation, and timeline — verify it before filing.
• A foreign manufacturer must work through an Indian Authorized Agent; the manufacturer cannot apply directly.
• Treat the license as a continuing obligation: pay the 5-year retention fee on time to avoid deemed cancellation.

This guide is for general informational purposes and does not constitute legal advice. Fee figures, timelines, and classification examples should be verified against the current CDSCO/SUGAM portal notifications or with a qualified regulatory consultant before filing.

Frequently Asked Questions