Understanding Form MD-14 & MD-15 for Medical Device Import Licence in India

Understanding Form MD-14 & MD-15 for Medical Device Import Licence in India

India regulates medical device imports under the Medical Devices Rules, 2017 (MDR 2017). For notified devices, Form MD-14 is the application form and Form MD-15 is the import licence.

What is Form MD-14?

Form MD-14 is the application used by an eligible Indian authorised agent to seek an import licence for regulated medical devices from the Central Licensing Authority (CLA).

Under Rule 34 of MDR 2017, the authorised agent appointed by an overseas manufacturer submits the application through the designated online system. The authorised agent must hold the applicable licence to manufacture for sale or distribution or a wholesale licence for sale or distribution, as required under the Rules. The application is submitted together with the prescribed fee and supporting documents specified under the Second and Fourth Schedules.

It is important to understand that MD-14 is only the application stage. It does not itself permit commercial import of the medical device. The applicant must successfully complete the regulatory process before the import licence is granted.

What is Form MD-15?

Form MD-15 is the import licence issued by the Central Licensing Authority when the application satisfies the applicable requirements under MDR 2017.

The licence covers the medical devices and overseas manufacturing site(s) approved by the CLA and identifies the authorised agent responsible for importing the products into India.

In practical terms:

• MD-14 = Application for import licence

• MD-15 = Import licence granted by the CLA

CDSCO itself identifies MD-14 as the application for obtaining an import licence in MD-15.

Who Can Apply for an MD-14?

An overseas manufacturer cannot ordinarily submit the import application independently in India. The manufacturer appoints an Indian authorised agent through a Power of Attorney (POA).

MDR 2017 defines an authorised agent as a person, firm or organisation appointed by an overseas manufacturer through a Power of Attorney to undertake the import of medical devices in India.

The authorised agent therefore plays a central role in the Indian regulatory process. The agent submits the application, communicates with CDSCO, maintains the applicable regulatory documentation and performs the responsibilities prescribed under MDR 2017.

The POA must also satisfy the applicable authentication requirements prescribed under the Fourth Schedule.

Documents Commonly Required for MD-14

The documentation package depends on the device, classification, manufacturer and applicable regulatory pathway. However, an import licence application generally requires information covering the applicant, overseas manufacturer, manufacturing site, device and regulatory status.

Commonly requested documents may include:

• Form MD-14 application

• Prescribed fee details

• Power of Attorney

• Authorised agent's applicable licence or registration

• Overseas manufacturer's details

• Manufacturing-site information

• Free Sale Certificate or Marketing Authorisation, where applicable

• Quality Management System certification

• Applicable conformity or CE-related documentation

• Manufacturer's Declaration of Conformity

• Product information and labelling

• Device Master File (DMF)

• Plant Master File (PMF)

• Safety and performance information

• Clinical or published evidence, where applicable

The Fourth Schedule of MDR 2017 specifies the documentation requirements for import applications. CDSCO's current import-licence checklist also identifies supporting documents relating to the manufacturer, manufacturing site, product and quality systems.

Device Master File and Plant Master File

Technical documentation is a significant component of an MD-14 submission.

The Device Master File (DMF) provides detailed information about the medical device, such as its intended purpose, design, materials, manufacturing process, safety and performance, verification and validation, labelling and other relevant technical information.

The Plant Master File (PMF) focuses on the manufacturing facility and provides information concerning the manufacturing site, processes, quality systems, facilities and controls.

These documents enable the regulator to assess whether the manufacturer and device meet the applicable regulatory requirements.

How Does the MD-14 to MD-15 Process Work?

The medical device import licensing process can broadly be understood as follows:

Step 1 – Identify the Regulatory Status of the Device

First, determine whether the product falls within the definition of a medical device under MDR 2017 and whether it requires an import licence.

The device should then be assigned the appropriate risk class—Class A, B, C or D— according to the First Schedule. CDSCO describes these as low, low-moderate, moderate-high and high-risk categories, respectively.

Step 2 – Appoint an Indian Authorised Agent

The overseas manufacturer appoints an eligible Indian authorised agent through the required Power of Attorney.

Step 3 – Prepare the Regulatory Dossier

The applicant compiles the legal, administrative, technical, manufacturing-site, quality and product documents required under MDR 2017.

Step 4 – Submit Form MD-14

The authorised agent submits the MD-14 application along with the applicable fee and supporting documents through the designated online system.

Step 5 – Regulatory Examination

CDSCO/CLA examines the submitted information and may request clarification or additional documentation where necessary.

Step 6 – Manufacturing Site Inspection, If Required

As part of the application assessment, the Central Licensing Authority may require an inspection of the overseas manufacturing facility. Such an inspection can be conducted by the CLA or by an authorised person or organisation acting on its behalf, as provided under Rule 35 of the Medical Devices Rules, 2017.

The purpose of the inspection is to evaluate the manufacturing facility, production arrangements and relevant quality and regulatory controls associated with the medical devices proposed for import into India. Where an inspection is ordered, the applicable inspection costs are to be borne by the applicant in accordance with the prescribed requirements.

Step 7 – Decision on the Import Licence

Once the application has been evaluated and any required inspection has been completed, the Central Licensing Authority considers the available information before making its decision.

If the regulatory requirements are satisfactorily met, the import licence is issued in Form MD-15. If the application does not meet the applicable requirements, the CLA may refuse the application and record the reasons for such refusal.

Key Compliance Responsibilities

Obtaining MD-15 is not the end goal of compliance. The authorised agent and overseas manufacturer must continue to comply with the conditions of the licence and MDR 2017.

They should ensure that:

• Imported products match the licensed details

• Approved manufacturing sites remain properly documented

• Labelling and packaging comply with applicable requirements

• Post-market obligations are addressed

• Relevant changes to approved information are assessed under applicable post-approval change requirements

• Regulatory records are maintained accurately

• Required regulatory communications are made in a timely manner

Any relevant changes in the submitted information or approved particulars should be assessed under the applicable post-approval change requirements before implementation. Accurate record-keeping and timely regulatory communication can help prevent compliance issues.

Conclusion

Forms MD-14 and MD-15 are essential components of the medical device import licensing framework under the Medical Devices Rules, 2017. MD-14 is used by the authorised Indian agent to submit the import licence application, whereas MD-15 is the licence issued by the Central Licensing Authority after the application fulfils the applicable regulatory requirements.

Successful licensing requires more than submitting an application; the applicant must provide appropriate product, manufacturing-site, technical, quality and regulatory information and ensure that the imported devices remain consistent with the approved licence particulars.

For overseas manufacturers entering the Indian market, early preparation of regulatory documents and a clear understanding of CDSCO requirements can make the licensing process more structured and efficient. Careful review of device classification, documentation, labelling, manufacturing-site information and post-licensing obligations can also help minimise avoidable regulatory queries.

Working with experienced regulatory professionals can further assist manufacturers and authorised agents in preparing submissions, addressing documentation gaps, coordinating with CDSCO, and managing ongoing compliance requirements.

Last Updated : 13 Aug 2026