Regulatory Approval of Medical Devices in India

How Are Medical Devices Approved in India? CDSCO, MD-14, and MD-15

Medical Devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) in accordance with the Medical Device Rules, 2017 (MDR 2017). Products are classified into risk classes A, B, C, and D on a risk-based basis (First Schedule).

The Central Licensing Authority has full authority over imports, regardless of the risk class. The application is submitted on Form MD-14, and the import license is issued on Form MD-15 (Rule 34). The applicant is not the manufacturer, but an Authorized Indian Agent holding their own wholesale or manufacturing license or an MD-42 registration certificate.

The core documents are the Device Master File (DMF) in accordance with Appendix II and the Plant Master File (PMF) in accordance with Appendix I of the Fourth Schedule, supplemented by a Free Sale Certificate, an ISO 13485 certificate, a CE certificate or FDA verification, and an apostilled Power of Attorney.

AUTHORITY

CDSCO

Central Drugs Standard Control Organisation

LEGAL BASIS

MDR 2017

Medical Device Rules, G.S.R. 78(E)

APPLICATION / LICENSE

MD-14 → MD-15

Application Form → Import License

LOCAL REQUIREMENT

Authorized Indian Agent

Legal entity, not a private individual

How are medical devices classified in India?

The Indian government recognizes four risk classes, A through D. The system is similar to the EU MDR. However, an EU Class IIa device does not automatically correspond to an Indian Class B device.

The determining factors are intended use, invasiveness, duration of contact, whether the device is active or implantable, and the overall risk. The classification determines the process, scope of documentation, and fees.

Class	Risk	Import Authority	License Required	Note
A	Low	Central Licensing Authority	MD-14 / MD-15 (exempt if non-sterile and non-measuring: registration only)	FSC from EU/US supports the application
B	Low to medium	Central Licensing Authority	MD-14 / MD-15 required	FSC from EU/US supports the application
C	Medium to high	Central Licensing Authority	MD-14 / MD-15 required	Higher clinical evidence requirements; FSC helps avoid a new clinical investigation
D	High	Central Licensing Authority	MD-14 / MD-15 required	Most thorough review; on-site inspection possible; FSC helps avoid a new clinical investigation

*FSC: Free Sales Agreement

Why is the CE marking not sufficient in India?

In India, the CE marking and FDA clearance are supporting documents that accompany the application, but they do not replace it. The CDSCO conducts its own review and issues its own license. However, a large portion of the EU/FDA documentation can be reused:

More specifically, you do not submit your technical documentation. Instead, you adapt it to the formats required by the CDSCO.

The most common mistake is that manufacturers interpret Classes A and B based on the State Licensing Authority and plan accordingly. However, this only applies to manufacturing in India. For imports, the Central Licensing Authority is always responsible, even for Class A devices.

What is the process for registration of medical devices in India?

The approval process for medical devices in India involves several steps. The following diagram shows the complete process, from classification under the Medical Device Rules 2017 through the Authorized Indian Agent, Device Master File, and Plant Master File, to the submission of the MD-14 application and the issuance of the MD-15 import license.

What documents does CDSCO require for the MD-15 import license?

The majority of this information is already included in your MDR technical documentation. However, CDSCO expects specific formats and a specific line of reasoning.

Device Master File (DMF)

In accordance with Fourth Schedule, Appendix II. Includes, among other things:

the product description
the intended use
design information
manufacturing details
Risk management
Clinical evidence
Verification and validation
Labeling
Instructions for Use (IFU)

Most of this information is already included in the EU technical documentation.

Plant Master File (PMF)

According to Fourth Schedule, Appendix I. Describes the manufacturing site and quality system:

Manufacturer information
Production site
Organizational structure
Manufacturing process
Facility layout
Cleanroom information (if applicable)
Production equipment
Quality management system in accordance with ISO 13485
Personnel and training
Process validation
Environmental controls
Calibration and maintenance
Complaint handling
CAPA
Internal audits

Additional Required Documents

Other generally required documents include:

Certificate of Free Sale
CE Certificate and/or FDA Approval
ISO 13485 Certificate
Power of Attorney for the Authorized Indian Agent
Labels and instructions for use in English, in accordance with Indian requirements
CDSCO application forms

What other medical device markets does WQS cover?

EU MARKET

CE Marking under the MDR

US MARKET

FDA Approval

INTERNATIONAL MARKETS

Global Market Access

Consulting for the Indian Market

We review your existing MDR or FDA dossier against CDSCO requirements and identify any gaps.

Frequently Asked Questions About Medical Devices in India

Consulting Medical Devices

Is the CE marking enough to gain market access in India?

No. India does not recognize the CE marking as approval. It serves as a supporting document in the CDSCO application. The CDSCO conducts its own review and issues its own import license on Form MD-15. The product may not be imported without Form MD-15.

What is the difference between MD-14 and MD-15?

MD-14 is the application form for the import license. MD-15 is the import license itself, issued by CDSCO. These are not two separate licenses, but rather the application and the approval notice. The application is submitted by the Authorized Indian Agent via the MD Online Portal.

Which authority is responsible for imports?

The Central Licensing Authority is exclusively responsible for imports, regardless of the product’s risk class. The State Licensing Authority’s jurisdiction over Classes A and B applies exclusively to manufacturing within India, not to imports.

How long is the MD-15 import license valid?

The MD-15 is valid indefinitely as long as the retention fee is paid. This fee is due every five years, calculated from the date of issuance of the base license. Additionally, updated documents must be submitted, including the ISO 13485 certificate, Free Sale Certificate, and PMS data for the past five years. A late payment fee applies in the event of delayed payment.

Can we reuse our EU technical documentation for India?

For the most part, yes. The Technical Documentation, the Clinical Evaluation Report, the Risk Management File, PMS and PMCF documentation, and the ISO 13485 certificate provide the foundation.

However, the formats are different. CDSCO requires a Device Master File in accordance with Appendix II and a Plant Master File in accordance with Appendix I of the Fourth Schedule. A conversion is necessary.

How long does it take to obtain authorization in India through the CDSCO?

The duration depends on the risk class and the completeness of the dossier. For imports, the application is always reviewed by the Central Licensing Authority, regardless of the risk class. Class A and B devices are typically processed within about 4 to 6 months, while Class C and D devices usually take 6 to 9 months or longer due to higher clinical evidence requirements and possible site inspections. The import license (MD-15) is issued after review of the Device Master File and Plant Master File. Queries from the authority regularly extend the process, which is why a complete, well-prepared dossier is the most effective way to shorten the timeline.

Sources and Regulatory Basis

Central Drugs Standard Control Organization: Medical Devices Rules, 2017 – cdsco.gov.in
Ministry of Health and Family Welfare: Medical Devices Rules, 2017, 31. January 2017 – cdsco.gov.in
Central Drugs Standard Control Organisation: Online System for Medical Devices – cdscomdonline.gov.in
Central Drugs Standard Control Organization: Checklist for the grant of Import license in Form MD-15 for Medical Devices under Medical Devices Rules, 2017 – cdsco.gov.in

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.