Import License for Predicate Medical Devices (Forms MD-14, MD-15)

CDSCO MD-14 Application & MD-15 Import Licence Consultancy Services

Foreign manufacturers planning to introduce regulated medical devices into the Indian market must follow the applicable requirements of the Medical Devices Rules, 2017. Depending on the regulatory status and category of the product, an import licence issued by the Central Licensing Authority may be required before commercial importation and distribution in India.

Under the Medical Devices Rules, 2017, an eligible authorised Indian agent submits an application in Form MD-14 for the grant of an import licence in Form MD-15 through the designated CDSCO online system.

MDR Consultants provides regulatory consulting and documentation support for MD-14 applications and the MD-15 medical device import licensing process in India.

Our services assist foreign manufacturers and Indian authorised agents with regulatory pathway assessment, device classification, technical documentation review, application preparation, and CDSCO submission support.

What Is an MD-15 Import Licence?

Form MD-15 is the import licence issued for medical devices under the applicable provisions of the Medical Devices Rules, 2017.

The process begins with an application in Form MD-14, submitted by an eligible authorised agent to the Central Licensing Authority through the designated online portal.

In simple terms:

Form	Regulatory Purpose
MD-14	Application for grant of an import licence
MD-15	Import licence granted by the Central Licensing Authority

The grant of an MD-15 licence is subject to regulatory review and satisfaction of the applicable requirements.

Who Can Apply for an MD-15 Import Licence?

A foreign manufacturer intending to import regulated medical devices into India must work through an eligible authorised Indian agent as required under the applicable provisions of the Medical Devices Rules, 2017.

The authorised agent acts as the regulatory interface between the overseas manufacturer and the Indian regulatory authority.

The authorised agent may be responsible for activities relating to:

Regulatory application submission;
Coordination with the foreign manufacturer;
Submission of prescribed documents;
Communication with CDSCO;
Response to regulatory queries;
Maintenance of applicable regulatory information; and
Other responsibilities arising under the applicable regulatory framework.

Eligibility of the authorised agent should be assessed in accordance with the Medical Devices Rules, 2017.

MD-14 and MD-15: Understanding the Difference

The terms MD-14 and MD-15 are frequently used together, but they refer to two different parts of the regulatory process.

Form MD-14 – Application

MD-14 is the prescribed application form used for seeking an import licence for medical devices.

The application is submitted through the applicable CDSCO online system along with the prescribed fee and supporting documentation.

Form MD-15 – Import Licence

MD-15 is the import licence issued by the Central Licensing Authority when the application meets the applicable regulatory requirements.

Therefore, MD-14 should not be described as an import licence itself. It is the application form, whereas MD-15 is the import licence.

Medical Device Classification in India

India follows a risk-based classification system for medical devices under the Medical Devices Rules, 2017.

The four principal risk classes are:

Class A – Low Risk
Class B – Low-Moderate Risk
Class C – Moderate-High Risk
Class D – High Risk

Correct classification is an important part of regulatory planning because the device classification, intended purpose, technology, and applicable regulatory provisions can influence the documentation and approval pathway.

Before preparing an import application, MDR Consultants can assist with an initial regulatory assessment of the product and its proposed route to the Indian market.

Documents Required for MD-14 Application

The documentation required for an MD-14 application should be prepared according to the Medical Devices Rules, 2017, the Fourth Schedule, applicable CDSCO checklists, and product-specific requirements.

The exact document package may vary depending on the medical device, manufacturing site, regulatory history, and nature of the application.

Typical documentation areas include the following.

01

Application Documents The application package may include:

Covering letter;
Application in Form MD-14;
Applicable government fee documentation;
Power of Attorney;
Undertaking from the authorised agent; and
Other prescribed declarations.

The Power of Attorney and related documents should be prepared and authenticated in accordance with the applicable regulatory requirements.

02

Authorised Indian Agent Documents Documentation relating to the authorised Indian agent may include:

Applicable wholesale licence;
Manufacturing licence, where relevant;
Registration Certificate in Form MD-42, where applicable;
Constitution documents of the authorised agent;
Authorisation from the foreign manufacturer; and
Required undertakings and declarations.

The regulatory eligibility of the proposed authorised agent should be reviewed before initiating the application.

03

Overseas Manufacturer Regulatory Documents Depending on applicability, CDSCO may require supporting evidence relating to the regulatory status of the manufacturer and product.
This may include:

Free Sale Certificate;
Marketing Authorization;
Manufacturing site or establishment registration;
Regulatory certificates issued by the competent authority;
Inspection or audit reports, where available and applicable; and
Other country-of-origin regulatory documentation.

Document validity, authentication, consistency, and applicability should be reviewed before submission.

04

Quality Management System Documentation The application may require documentation demonstrating the quality management arrangements applicable to the actual manufacturing site.
Depending on the circumstances, relevant documents may include:

Quality Management System certificates;
ISO 13485 certification, where applicable;
Full Quality Assurance certificates;
CE-related conformity certificates, where applicable;
CE Type Examination documentation, where applicable;
CE Design Certificates, where applicable;
Product Quality Assurance certificates; and
Declaration of Conformity issued by the manufacturer.

Certificates should correspond appropriately to the actual manufacturing site and product under application.

Plant Master File (PMF)

CDSCO's MD-14 checklist identifies the requirement for a Plant Master File from the manufacturer in accordance with Appendix I of the Fourth Schedule of the Medical Devices Rules, 2017.

The Plant Master File generally provides information concerning the manufacturing establishment and quality systems.

The information should accurately represent the actual manufacturing site associated with the medical devices proposed for import into India.

Key areas requiring consistency may include:

Manufacturing site details;
Organisation and personnel;
Quality management arrangements;
Manufacturing operations;
Facility controls;
Equipment and infrastructure;
Quality control activities; and
Other applicable manufacturing information.

Device Master File (DMF)

A Device Master File is an important part of the technical documentation package for an MD-14 application.

CDSCO's checklist refers to preparation of the Device Master File in accordance with Appendix II of the Fourth Schedule of the Medical Devices Rules, 2017.

The content of the Device Master File should be appropriate to the specific medical device and should not be prepared using a generic, one-size-fits-all approach.

Depending on the product, technical documentation may address:

Executive summary;
Device description;
Intended purpose;
Indications and instructions for use;
Product specifications;
Models and variants;
Accessories;
Materials and components;
Device design information;
Manufacturing information;
Product grouping justification, where applicable;
Labelling and packaging;
Essential Principles compliance;
Risk management documentation;
Verification and validation data;
Performance evaluation;
Biocompatibility data, where applicable;
Biological safety information;
Sterilization validation, where applicable;
Software validation, where applicable;
Stability information;
Clinical evidence or performance data, where applicable;
Post-market information; and
Other device-specific supporting evidence.

The depth and type of evidence should be determined according to the characteristics and risk profile of the individual device.

MD-15 Import Licence Application Process

Step 1: Regulatory Pathway Assessment The process begins with an assessment of the product to determine its regulatory status in India.
Important factors include:

Product type;
Intended purpose;
Medical device classification;
Technology involved;
Sterility status;
Measuring function;
Existing regulatory approvals; and
Applicable Indian regulatory provisions.

A proper regulatory assessment at the beginning can help avoid selecting an incorrect application pathway.

Step 2: Appointment of an Eligible Authorised Agent Foreign manufacturers seeking to import medical devices into India must identify an eligible authorised Indian agent in accordance with the applicable requirements.
The authorised agent is responsible for submitting the application and acting as the regulatory contact in India.

Step 3: Documentation Gap Assessment Before preparing the final application, available manufacturer and product documents should be reviewed against the applicable CDSCO requirements.
A documentation gap assessment may identify issues relating to:

Missing certificates;
Inconsistent manufacturer information;
Manufacturing-site discrepancies;
Incomplete technical documentation;
Labelling inconsistencies;
Insufficient device specifications; or
Missing validation and performance evidence.

Addressing significant gaps before submission can improve the overall quality and organisation of the application.

Step 4: Preparation of PMF and DMF The Plant Master File and Device Master File should be organised according to the applicable requirements of the Fourth Schedule.
Technical documents should remain consistent across the entire submission.
For example, the following information should generally align wherever applicable:

Manufacturer name;
Manufacturing site;
Device name;
Model or variant;
Intended purpose;
Product specifications;
Labelling;
Quality certificates; and
Regulatory certificates.

Step 5: Preparation of Form MD-14 The authorised Indian agent prepares the application in Form MD-14 and compiles the prescribed supporting documentation.
The submission should be reviewed carefully for completeness and consistency before filing.

Step 6: Payment of Applicable Government Fees The prescribed fee must be paid in accordance with the applicable provisions and fee schedule.
The fee structure may differ depending on the nature and scope of the application.

Step 7: Submission Through the CDSCO Online System The application and supporting documents are submitted through the designated CDSCO online system.
Applicants should ensure that the information entered on the portal is consistent with the submitted regulatory and technical documentation.

Step 8: Regulatory Review The Central Licensing Authority reviews the application and supporting documents.
Depending on the application and regulatory assessment, clarification or additional information may be requested.
Where considered necessary under the applicable rules, the regulatory authority may also require evaluation, testing, examination, or other regulatory action.
Applicants should respond to regulatory queries with technically accurate and consistent documentation.

Step 9: Grant of MD-15 Import Licence Where the Central Licensing Authority is satisfied that the applicable requirements have been met, an import licence may be granted in Form MD-15.
The licence should be reviewed carefully to ensure that the authorised manufacturer, manufacturing site, and medical devices are correctly reflected.

Fresh Application and Additional Device Applications

CDSCO's checklist distinguishes between different application scenarios, including fresh applications and applications involving additional medical devices.

The documentation requirements may vary depending on whether the applicant is:

Applying for an initial import licence;
Adding medical devices to an existing licence;
Adding a manufacturing site; or
Making another regulatory change requiring approval or endorsement.

The appropriate regulatory route should therefore be determined before initiating the submission.

Common Challenges in MD-15 Applications

MD-15 applications often involve extensive coordination between the overseas manufacturer and the Indian authorised agent.
Common challenges include:

01

Incorrect Device Classification

An inaccurate classification can affect the regulatory strategy and supporting documentation.

02

Incomplete Device Master File

Generic or incomplete technical files may not adequately address the characteristics of the medical device.

03

Manufacturing Site Inconsistencies

Differences between certificates, PMF, Free Sale Certificates, and application details can create avoidable queries.

04

Labelling Gaps

Product labels and Instructions for Use should be reviewed for consistency with applicable Indian requirements and the technical documentation.

05

Regulatory Certificate Issues

Certificates may require review for validity, applicability, authentication, and consistency with the manufacturer and manufacturing site.

06

Inadequate Grouping Justification

Where multiple models or devices are proposed within an application, appropriate grouping justification may be necessary.

MDR Consultants

Consider Partnering with MDR Consultants

MDR Consultants provides specialised regulatory consulting support for companies navigating the Indian medical device import licensing process.

Our services may include:

Regulatory Strategy and Classification
• Medical device regulatory pathway assessment;
• Device classification review;
• Product eligibility assessment;
• Import licensing strategy.
Documentation Support
• MD-14 application documentation review;
• Documentation gap assessment;
• Device Master File review;
• Plant Master File review;
• Regulatory certificate review;
• Quality documentation assessment.
Technical Documentation Support
• Device description review;
• Intended use assessment;
• Product grouping support;
• Essential Principles documentation review;
• Risk management documentation review;
• Performance and validation documentation assessment.
Labelling Support
• Product label review;
• Instructions for Use review;
• Regulatory consistency assessment.
Application and Submission Support
• MD-14 application preparation support;
• Document compilation;
• CDSCO online submission assistance;
• Application consistency review;
• Regulatory query coordination and response support.