MD-16 Import License for Medical Devices | CDSCO Import Registration

MD-16 Import License for Medical Devices Overview

Importing medical devices into India is an intricate process that requires approval from the Central Drugs Standard Control Organisation (CDSCO). Every medical device entering India must follow CDSCO rules before it can be cleared for import.

CDSCO is the government authority that approves, monitors, and controls medical device imports. Based on the purpose of import, the importer must apply for the correct medical device import license in India.

To bring in medical devices for testing, evaluation, or research, the importer must apply through form MD-16. This MD-16 import license assures that sample or test imports meet safety and compliance requirements before they move further in the regulatory process.

The entire process is crucial, as even a small mistake in documents can impact shipment time. This is why many importers seek the support of professionals to ensure medical device importer registration is done correctly, right from the start.

We at ComplifyXpert provide all-inclusive support for MD-16 Import License applications, including document review, application filing, and CDSCO compliance guidance for smooth approval. Take a free consultation today!

What is an MD-16 Import License?

Under the Medical Device Rules 2017, the MD-16 import is an application form used to bring medical devices into India for testing, training, or clinical investigation. This authorisation allows an Indian importer to legally import sample medical devices made by overseas companies for non-commercial purposes.

CDSCO checks information on the importer, the foreign manufacturer, and the device through the MD-16 application. Reviewing the technical file, checking safety data, and confirming that the manufacturer adheres to quality criteria such as ISO 13485 are among the processes.

The aim of the MD-16 license is to guarantee that only safe, tested and approved equipment is imported. This helps to safeguard health professionals and patients as well as preserve the market free from low-quality or harmful products.

So, any importer who wants to supply medical devices for testing must apply for the appropriate CDSCO import registration for lawful entry of their products.

Who Needs an MD-16 Import License?

Any person or business that imports medical devices into India must apply for the MD-16 import license. It is not optional. Whether you import small accessories or complex machines, this license is required before customs clearance.

You must apply for MD-16 if you are:

• A distributor importing devices from abroad
• A trader purchasing equipment from foreign suppliers
• An online seller bringing devices into India
• A hospital or lab importing specialised equipment
• A service provider bringing spare parts or consumables

Even if the quantity is small or a one-time import, the license is still mandatory.

Before selling in India, any importer registering medical devices must finish the MD-16 process. 

Device Classes Under Coverage of MD-16 Import License

Based on risk, the medical device import license India guidelines divide devices into four categories: the MD-16 import license encompasses all four:

Class A (Low Risk)

These include basic devices with little user risk.

Instances:

• Thermometers
• Stethoscopes
• Surgical handwear

Class B (Low to moderate risk)

Basic safety and performance inspections are required for these machines.

Cases:

• Needles
• Catheters
• Devices for blood pressure monitoring

Class C (Moderate to high risk)

These demand thorough technical documentation and solid safety data.

Illustrations include:

• Infusion devices
• Accessories for a ventilator
• Diagnostic tools

Class D (High Risk)

Strict examination of these frequently life-saving tools is required. Examples:

• Valves for hearts
• Pacemakers
• Dialysis machines

The class, intended use and model specifics have to be clearly stated on your MD-16 application. Incorrect categorisation could result in delays or rejection.

Who Is Eligible for MD-16 Import License?

You have to fulfill the fundamental criteria established by CDSCO to get an MD-16 import license. You qualify if:

• You have a legitimate Import Export Code, also known as an IEC code.
• Business registration in India under your name.
• You own or rent a warehouse with enough storage capacity.
• You possess an authorisation letter from the overseas producer.
• Your foreign manufacturer authorisation meets global quality standards.
• You can upload device details and safety documents.
• You have access to the CDSCO portal for online filing.

If you meet these points, you can move to the documentation phase. 

Documents Required for MD-16 Import License

An MD-16 import license needs clear and complete documents. CDSCO only accepts correct, readable and updated files. Keep the following papers ready before filing on the CDSCO portal:

• Importer Documents
• Form MD-16 application
• Business registration certificate
• Import Export Code (IEC)
• Warehouse or storage details
• List of devices with model numbers
• Letter of undertaking from the importer
• Details of authorised signatory
• Proof of government fee payment

Foreign Manufacturer Requirements

• Manufacturing license copy
• Quality Management System proof (ISO 13485)
• Free Sale Certificate or equivalent
• Device Master File (DMF)
• Plant Master File (PMF)
• Test reports and performance data
• Risk analysis documents
• Device labels and artwork
• Packaging details
• List of models and variants

An authorisation letter naming the Indian importer

Additional Supporting Papers

• Product catalog
• Instructions for use
• Clinical evidence (if required)
• Safety certificates
• FDA approval or CE certificate (when applicable)

A well-prepared document set helps avoid extra queries and long delays. 

Application Process for Availing MD-16 Import License

The MD-16 process follows a clear step-by-step method. Each stage must be completed with care to avoid delay or rejection. Below is the full procedure for CDSCO registration.

STEP-1. Create an Account on the CDSCO Portal

• First, you must create a user account on the CDSCO online portal.
• Register your business with the correct legal details.
• Complete your user and company profile.
• Upload basic documents like PAN, GST and authorisation letters.
• Make sure all details match your legal records.

STEP-2. Choose the Form MD-16 Section

After logging in, go to the medical device import section on the portal. From the menu, select the Form MD-16 application option. This is the form used to apply for the MD-16 import license.

STEP-3. Fill Importer Details

In this part, you must give full details of your business such as

• Importer name and legal status
• Registered office address
• Warehouse or storage location
• IEC code
• Email ID and phone number

These details will appear on your license, so they must be accurate.

STEP-4. Add Device Details

Next, you have to give information about the devices you want to import.

• Device name and its description
• Model numbers, including all the variants
• Device category (A, B, C, or D)
• Use and reason for the device
• The country where it is made

This information makes it easier for CDSCO to determine the medical device import restrictions and to assign a risk level to the device.

STEP-5. Enter Foreign Manufacturer Details

Now, provide the foreign manufacturer’s information. Included in this step is the uploading of

• Factory's location and telephone number
• QMS details like ISO 13485
• Certified copies of the manufacturing license
• Plant Master File (PMF) and Device Master File (DMF)

These documents are evidence that the manufacturer is maintaining the required quality and safety standards.

STEP-6. Post All Needed Documents

After completion of all the above applications, the whole set of documents should be posted. Make sure that all the files are

• Clear and readable
• Up to date and valid
• In the file format as per the portal rules
• Within the maximum size limit

Poor quality or unclear documents often result in queries and further processing delays.

STEP-7. Pay the Government Fee

After uploading the documents, pay the fee using the online method provided by the portal. The amount of the fee is based on the following:

• Category of device
• Number of models and variants
• Type and classification of the device

Do not lose the payment receipt, as it may be required in the future.

STEP-8. CDSCO Review

After submission, your application will be reviewed by CDSCO officers. They will verify

• Technical data and performance reports
• Safety reports and risk assessments
• An authorisation letter from the foreign manufacturer
• Labels, artwork, and IFU (instructions for use)
• Compliance of total device import with the medical device import rules

 If everything checks out, the file is forwarded to CDSCO import approval.

STEP-9. Answer Queries (If Any)

In case of any shortcomings, CDSCO may raise questions or request additional documents. In such a situation, you have to

• Look for any queries in the portal and your email
• Provide an answer within the specified time
• Submit the corrected or missing documents
• Quick and clear communication helps in avoiding long delays.

STEP-10. Receive MD-16 Approval

Once the application is accepted, CDSCO issues the MD-16 import license. The final license is

• Issued online through the CDSCO portal
• Linked to your importer account
• Available for download and use during customs and audits

You must keep a copy of the MD-16 license for records and customs clearance checks.

If you need guidance at any step of this process, you can reach out to ComplifyXpert for support. Our team can help with paperwork, document review, and full device import compliance checks to make sure your MD-16 application is filed correctly.

Foreign Manufacturer Requirements for MD-16 Import License

Your supplier abroad must provide correct and updated documents to support your application. CDSCO verifies their details with much attention.

The foreign manufacturer must have

• A valid manufacturing license
• ISO 13485 or equivalent QMS
• Free Sale Certificate from the country of origin
• Device Master File (DMF) with safety data
• Plant Master File (PMF) with process details
• An authorisation letter naming the Indian importer
• Clear label artwork
• Updated test reports
• Risk analysis details
• Proper device classification
• Model and variant list
• Instructions for use (IFU)

If the manufacturer does not cooperate, the MD-16 import license cannot be completed. Importers must choose reliable suppliers who understand Indian regulatory compliance.

Timeline for MD-16 Import License

The approval time for the MD-16 import license varies based on document quality and device type. The usual timeline is

• 4-8 weeks for most devices
• 8-12 weeks for Class C and Class D devices
• Extra time if there are queries or missing papers

Delays happen when

• The authorisation letter is old
• Test reports are missing
• Files are unclear
• Device classification is wrong
• PMF or DMF is incomplete 

With complete documents, approval is smooth and faster. 

Fees for Taking MD-16 Import License

The fees for the MD-16 import license depend on the device class and the number of models.

Government fees may include:

• Fee per device type
• Fee per model
• Fee per class, in some cases

Other costs may include:

• Medical Device Testing costs (if samples are needed)
• Compliance consultant fee
• Document preparation charges 

Importers must check the latest CDSCO fee structure before filing.

Validity of MD-16 Import License

The MD-16 import license is valid for 3 years from the date of issue. During this period, you can import the approved devices without extra permits.

To maintain import license validity

• Keep QMS active
• Keep authorisation letter updated
• Ensure device details remain unchanged
• Maintain proper storage and records

If major changes occur, you must file a modification request. 

Modification of MD-16 Import License

You must update your MD-16 license if there are changes in

• Manufacturer name
• Manufacturing site address
• Device model or variant list
• Warehouse location
• Authorised agent
• Company name or structure
• Label details

Failing to modify may result in compliance issues or customs delays.

Renewal of MD-16 Import License

Renew your MD-16 license before it expires to avoid problems at customs. The renewal process needs:

• Updated Free Sale Certificate
• Updated authorisation letter
• Latest QMS certificate
• Updated device list
• Renewal fee payment
• Any revised PMF or DMF details

Renewing on time ensures smooth imports without disruptions.

Common Mistakes to Avoid When Applying for MD-16 Import License

Many importers face problems during the MD-16 application due to simple errors. Common issues include

• Wrong device classification
• Old or incorrect authorisation letter
• Poor-quality PDF uploads
• Missing pages in DMF or PMF
• The label artwork does not match the device.
• Using outdated QMS certificates
• Mistakes in the IEC code or the importer details
• Incomplete risk analysis

These mistakes can cause long delays or license rejection. To avoid such issues, experts can review your documents before submission.

Benefits of Having MD-16 Import License

The MD-16 import license provides several benefits to importers and helps maintain safe medical practices in India.

Key advantages include

• Legal permission to import devices
• Smooth customs clearance
• Higher trust among hospitals and buyers
• Access to wider international markets
• Ability to import high-quality devices
• Better supply chain control
• Improved business growth
• Compliance with Indian medical device rules

A valid license also shows your company follows strict safety and quality standards.

Why Choose ComplifyXpert to Apply for an MD-16 Import License?

Since availing of the MD-16 import license is a complex task, you may need expert guidance. But you may wonder why choose ComplifyXpert when there are several options out there. The common reasons are as follows.

Clear Guidance from Start to Finish: We handle your MD-16 application step by step so that every document is correct for smooth CDSCO approval.

Safe Document Handling: All importer and manufacturer details are securely managed, keeping your files accurate and ready for review.

Direct Coordination with CDSCO: We are your point of contact with CDSCO, which reduces queries and keeps the process on track.

Simple Explanation: We explain each step in understandable terms and keep you informed about the status of your application.

Fast and Reliable Support: Our team answers questions and provides guidance throughout in order to complete the MD-16 process quickly and correctly.

Start Your MD-16 Import License Application Today

Confused about how to get MD-16 import license for medical devices? Or need help filing your MD-16 import license or completing your CDSCO registration? ComplifyXpert prepares your documents, files your application, and guides you through every step until approval. Get in touch with us for fast, simple, and compliant filing support!