CDSCO Medical Device Test License Registration Guide(2026)

If you are planning to manufacture, import, research, evaluate, or conduct performance testing of medical devices in India, obtaining a CDSCO Medical Device Test License may be an essential regulatory requirement. The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Devices Rules, 2017, to ensure their safety, quality, and performance. Whether you are a manufacturer, importer, research institution, or medical device company in Delhi, Noida, Gurugram, Mumbai, Bengaluru, Hyderabad, Chennai, Pune, Ahmedabad, or anywhere in India, understanding the test license process can help you avoid delays, penalties, and regulatory issues. This guide explains everything you need to know in 2026.

What is a CDSCO Medical Device Test License?

A CDSCO Medical Device Test License is a regulatory permission issued under the Medical Devices Rules, 2017, allowing eligible organizations to manufacture or import medical devices for testing, evaluation, examination, demonstration, or other approved purposes before commercial distribution, where applicable under the relevant regulatory provisions.

This license helps ensure that medical devices are tested and evaluated according to Indian regulatory standards before they are introduced into the market or used for specified regulatory purposes.

Why is a CDSCO Medical Device Test License Important?

Obtaining a Medical Device Test License offers several advantages:

• Ensures compliance with CDSCO regulations.

• Enables lawful testing and evaluation of medical devices.

• Supports product development and innovation.

• Helps manufacturers generate regulatory data.

• Improves product quality and safety.

• Builds confidence among regulators and customers.

• Facilitates smoother regulatory approvals.

Who Needs a CDSCO Medical Device Test License?

A Medical Device Test License may be required by organizations such as:

• Medical device manufacturers

• Medical device importers

• Research and development organizations

• Medical colleges

• Testing laboratories

• Government institutions

• Start-ups developing innovative medical devices

• Companies conducting product evaluation before commercialization

Eligibility Criteria

Applicants generally should satisfy the following requirements:

• Registered business entity in India (where applicable)

• Purpose of testing or evaluation clearly defined

• Required infrastructure and technical facilities

• Qualified technical personnel

• Compliance with applicable CDSCO regulations

• Proper documentation supporting the intended use

Documents Required

The exact document requirements may vary depending on the purpose of the application. Commonly required documents include:

• Company Incorporation Certificate

• PAN Card

• GST Registration

• Address Proof

• Authorization Letter

• Product Details

• Device Description

• Intended Purpose

• Technical Documents

• Test Protocol

• Quality Management Documents

• Identity Proof of Authorized Signatory

• Undertaking and Declaration

Preparing complete and accurate documentation significantly improves the chances of timely application processing.

CDSCO Medical Device Test License Registration Process

Step 1 – Identify the Purpose

Determine whether the medical device is intended for testing, evaluation, demonstration, research, or another permitted regulatory purpose.

Step 2 – Collect Required Documents

Compile all technical, legal, and business documents required for the application.

Step 3 – Prepare Technical Information

Prepare complete information about the medical device, including specifications, intended use, safety details, and supporting technical documents.

Step 4 – Submit the Application

File the application through the applicable CDSCO online portal along with the prescribed documents and government fees, if applicable.

Step 5 – Regulatory Review

CDSCO reviews the submitted documents and may request additional information or clarifications.

Step 6 – Approval

After satisfactory review and fulfillment of applicable requirements, the authority may grant the relevant test license or permission.

Common Reasons for Delay

Many applications are delayed due to avoidable mistakes, including:

• Incomplete documentation

• Incorrect device classification

• Missing technical information

• Errors in the application

• Inconsistent product details

• Failure to respond promptly to regulatory queries

• Submission of outdated documents

Carefully reviewing the application before submission helps reduce the risk of delays.

Benefits of Professional Compliance Support

The regulatory process can involve multiple technical and documentation requirements. Professional guidance can help applicants:

• Prepare accurate documentation

• Reduce application errors

• Respond effectively to regulatory queries

• Improve compliance with applicable requirements

• Save time during the approval process

• Minimize the risk of application rejection

Professional compliance support is particularly valuable for first-time applicants and organizations introducing new medical devices into the Indian market.

Frequently Asked Questions (FAQs)

1. What is a CDSCO Medical Device Test License?

A CDSCO Medical Device Test License is a regulatory permission that allows eligible organizations to manufacture or import medical devices for testing, evaluation, examination, demonstration, research, or other approved purposes under applicable CDSCO regulations.

2. Who needs a CDSCO Medical Device Test License?

Medical device manufacturers, importers, research institutions, testing laboratories, healthcare organizations, and companies conducting product evaluation may require a CDSCO Medical Device Test License, depending on the intended purpose.

3. What documents are required for a CDSCO Medical Device Test License?

Applicants generally need business registration documents, product details, technical documentation, authorization letters, identity proof, quality-related documents, and other supporting records as required by CDSCO.

4. How do I apply for a CDSCO Medical Device Test License?

The application is submitted through the CDSCO online portal along with the prescribed documents and applicable government fees, followed by document verification and regulatory review.

5. How long does it take to obtain a CDSCO Medical Device Test License?

The approval timeline depends on the completeness of the application, document verification, regulatory review, and any additional information requested by CDSCO.

6. Is a CDSCO Medical Device Test License mandatory?

If a medical device is intended for testing, evaluation, research, demonstration, or other regulated purposes covered under CDSCO requirements, obtaining the appropriate permission may be mandatory.

7. What are the common reasons for application rejection?

Applications may be delayed or rejected due to incomplete documentation, incorrect product information, missing technical details, inaccurate declarations, or failure to meet regulatory requirements.

8. Can imported medical devices be brought into India for testing?

Yes, imported medical devices may be permitted for testing or evaluation, subject to compliance with applicable CDSCO regulations and approval requirements.

9. What is the validity of a CDSCO Medical Device Test License?

The validity depends on the specific approval granted by CDSCO and the applicable regulatory provisions.

10. How can PSR Compliance help with a CDSCO Medical Device Test License?

PSR Compliance provides end-to-end assistance with documentation, application filing, regulatory guidance, compliance support, and coordination throughout the CDSCO Medical Device Test License process to help businesses achieve timely approvals.

Company Name: PSR Compliance

Phone: +91 7065883416

Email: support@psrcompliance.com

Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Website: https://www.psrcompliance.com

CDSCO MD-9 License Complete Guide for Class C & D Medical Device Manufacturing in India (2026)

Are you planning to manufacture Class C or Class D medical devices in India? If yes, obtaining a CDSCO MD-9 License is a mandatory regulatory requirement before manufacturing, selling, or distributing these high-risk medical devices. Under the Medical Devices Rules, 2017, manufacturers must obtain the MD-9 License from the Central Drugs Standard Control Organisation (CDSCO) after submitting an application in Form MD-7 and successfully completing document verification and facility inspection. Whether your manufacturing unit is located in Delhi, Noida, Gurgaon, Mumbai, Pune, Chennai, Hyderabad, Bengaluru, Ahmedabad, or anywhere in India, complying with CDSCO regulations is essential for legal market access. This guide explains the CDSCO MD-9 License, eligibility, registration process, required documents, government fees, compliance requirements, validity, and common mistakes to help manufacturers achieve faster approval in 2026.

What is a CDSCO MD-9 License?

A CDSCO MD-9 License is the manufacturing license issued by the Central Licensing Authority for the manufacture, sale, and distribution of Class C and Class D medical devices in India. It is issued after an application in Form MD-7 is reviewed and the manufacturing facility complies with the Medical Devices Rules, 2017.

Who Needs an MD-9 License?

Manufacturers producing Class C and Class D medical devices generally require an MD-9 License, including those manufacturing:

• Ventilators

• Dialysis equipment

• Infusion pumps

• MRI systems

• CT scanners

• Pacemakers

• Implantable medical devices

• High-risk diagnostic equipment

Benefits of Obtaining an MD-9 License

• Legal authorization to manufacture Class C & D medical devices

• Compliance with CDSCO regulations

• Improved customer confidence

• Easier participation in government tenders

• Better export opportunities

• Reduced regulatory risk

• Improved quality management

Eligibility Criteria

Applicants should generally have:

• A registered manufacturing company

• Manufacturing premises complying with applicable GMP and quality requirements

• Qualified technical personnel

• Quality Management System documentation

• Device Master File and Plant Master File

• Required infrastructure and testing facilities

Documents Required for MD-9 License

Prepare the following documents:

• Company Incorporation Certificate

• PAN & GST Registration

• Manufacturing Site Details

• Device Master File (DMF)

• Plant Master File (PMF)

• ISO 13485 Certificate (where applicable)

• Quality Management System documents

• List of Equipment

• Technical Staff Details

• Product Labels

• Risk Management Documents

• Clinical or performance evidence (where applicable)

• Authorization documents

Step-by-Step CDSCO MD-9 Registration Process

Step 1: Device Classification

Identify whether the product falls under Class C or Class D.

Step 2: Prepare Technical Documents

Compile the Device Master File, Plant Master File, quality documents, and supporting technical information.

Step 3: Submit Form MD-7

Submit the online application through the CDSCO Medical Device portal.

Step 4: Pay Government Fees

Pay the prescribed government fee based on the number of manufacturing sites and devices.

Step 5: CDSCO Review

The Central Licensing Authority reviews the submitted application and supporting documents.

Step 6: Manufacturing Site Inspection

CDSCO conducts an inspection of the manufacturing facility before granting approval for Class C and D devices.

Step 7: License Grant

After successful review and inspection, the manufacturing license is issued in Form MD-9.

Government Fees

Government fees depend on the number of manufacturing sites and medical devices covered by the application. Applicants should verify the latest fee schedule before submission.

Common Reasons for Application Rejection

• Incomplete documentation

• Incorrect device classification

• Missing technical data

• Poor Quality Management System

• Non-compliance during inspection

• Incorrect product labeling

• Delayed response to CDSCO queries

Compliance After Receiving MD-9 License

Manufacturers should continue to:

• Maintain quality records

• Report adverse events where required

• Follow labeling regulations

• Maintain manufacturing standards

• Cooperate with regulatory inspections

• Keep technical documentation updated

Why Choose PSR Compliance?

PSR Compliance offers complete assistance for:

• CDSCO Medical Device Registration

• MD-9 License Documentation

• Device Classification

• Technical File Preparation

• Application Filing

• Regulatory Support

• Query Resolution

• End-to-End Compliance Assistance

Frequently Asked Questions

What is the CDSCO MD-9 License?

The MD-9 License is the manufacturing license issued for Class C and Class D medical devices after approval of the MD-7 application.

Is the MD-9 License mandatory?

Yes, manufacturers of Class C and Class D medical devices generally require this license before commercial manufacturing.

Which authority issues the MD-9 License?

The Central Licensing Authority under CDSCO issues the MD-9 License.

Which form is used to apply?

Applications are submitted using Form MD-7, while the manufacturing license is issued in Form MD-9.

Can PSR Compliance assist with the process?

Yes. PSR Compliance provides complete support from documentation to regulatory approval.

Get Expert Assistance for CDSCO MD-9 License

Planning to manufacture Class C or Class D medical devices? Let PSR Compliance simplify your CDSCO approval process with expert regulatory guidance and end-to-end documentation support.

Conclusion

Obtaining a CDSCO MD-9 License is an essential regulatory requirement for manufacturers of Class C and Class D medical devices in India. The license ensures that your manufacturing facility complies with the Medical Devices Rules, 2017, helping you legally manufacture, market, and distribute high-risk medical devices while maintaining quality and safety standards. By understanding the eligibility criteria, documentation requirements, application process, and ongoing compliance obligations, businesses can avoid delays, penalties, and regulatory challenges.

If you are planning to apply for a CDSCO MD-9 License, partnering with experienced regulatory professionals can simplify the entire process. PSR Compliance offers end-to-end support for documentation, application filing, regulatory compliance, and CDSCO approvals, helping manufacturers obtain their licenses efficiently and focus on growing their business with confidence.

Company Name: PSR Compliance

Phone: +91 7065883416

Email: support@psrcompliance.com

Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Website: https://www.psrcompliance.com…

Medical Device Import License (MD-15 License) in India

If you want to import medical devices into India, obtaining an MD-15 License is one of the most important legal requirements. Without this license, medical devices cannot be imported, sold, or distributed in the Indian market unless exempted under applicable regulations.

Many businesses are unaware of the difference between MD-14 and MD-15, which often leads to confusion during the application process. Simply put, MD-14 is the application form, while MD-15 is the Import License issued by the Central Drugs Standard Control Organization (CDSCO) after successful approval.

Whether you are importing diagnostic equipment, surgical instruments, hospital devices, implants, or any other notified medical device, understanding the licensing process can save both time and money.

In this guide, you will learn everything about the Medical Device Import License (MD-15 License) in simple language, including eligibility, required documents, application steps, government fees, validity, and common mistakes to avoid.

What is an MD-15 License?

An MD-15 License is an official Medical Device Import License issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017.

This license allows an importer to legally import notified medical devices into India for sale and distribution.

The application is submitted online through the CDSCO SUGAM Portal using Form MD-14. After CDSCO reviews and approves the application, the authority issues the MD-15 License.

Simply remember:

Form	Purpose
MD-14	Application for Import License
MD-15	Import License issued by CDSCO

Why is an Medical Device Import License Required?

India regulates medical devices to ensure they are safe, effective, and meet quality standards before reaching patients.

The MD-15 License helps CDSCO verify that imported medical devices:

• Meet Indian regulatory requirements

• Are manufactured in approved facilities

• Follow international quality standards

• Are safe for patients

• Have proper labeling and documentation

Without an Import License, medical devices cannot legally enter the Indian market.

Who Needs an MD-15 License?

An MD-15 License is generally required by:

• Medical device importers

• Indian authorized agents of foreign manufacturers

• Medical equipment distributors

• Healthcare product companies

• Diagnostic equipment suppliers

• Hospital equipment importers

• Implant import companies

• Medical technology businesses

If a foreign manufacturer wants to sell products in India, they usually appoint an Indian Authorized Agent to apply for the Import License through CDSCO.

Which Medical Devices Require an Import License?

Most notified medical devices require CDSCO approval before import.

Examples include:

• X-ray machines

• MRI machines

• CT scanners

• Ultrasound equipment

• ECG machines

• Blood pressure monitors

• Surgical instruments

• Orthopedic implants

• Cardiac stents

• Diagnostic kits

• Disposable medical devices

• Dental equipment

• Laboratory equipment

• Patient monitoring systems

• Infusion pumps

The applicable regulatory requirements depend on the device classification and notification status under the Medical Devices Rules.

Eligibility for Medical Device Import

To apply for an Import License, the applicant should generally have:

• An Indian business entity

• Authorized Agent authorization (if representing a foreign manufacturer)

• Manufacturing details

• Quality certifications

• Technical documentation

• Device information

• Valid business registrations

• Compliance with CDSCO requirements

Documents Required for MD-15 License

The documents may vary depending on the device category, but commonly required documents include:

• Cover letter

• Application Form MD-14

• Power of Attorney

• Authorization Letter

• Free Sale Certificate

• ISO 13485 Certificate

• Quality Management System Certificate

• Device Master File

• Plant Master File

• CE Certificate (where applicable)

• Product catalogue

• Labels

• Instructions for Use (IFU)

• Declaration of Conformity

• Business registration documents

• Import Export Code (IEC)

• PAN

• GST Registration

• Undertaking

• Technical specifications

Providing complete and accurate documents helps avoid delays during CDSCO review.

How to Apply for an MD-15 License?

The application process is completely online.

Step 1: Create an Account on CDSCO SUGAM

Register your organization on the CDSCO SUGAM Portal.

Step 2: Prepare the Required Documents

Collect all technical, legal, and regulatory documents before starting the application.

Step 3: Submit Form MD-14

Complete the online application in Form MD-14 and upload the required documents.

Step 4: Pay Government Fees

Pay the applicable government fee through the online portal.

Step 5: CDSCO Review

CDSCO officials review the submitted documents and may request clarification or additional information.

Step 6: License Approval

If all requirements are fulfilled, CDSCO issues the Medical Device Import License in Form MD-15.

Role of CDSCO SUGAM Portal

The CDSCO SUGAM Portal is the official online platform used for medical device licensing.

Through the portal, applicants can:

• Register an account

• Apply for licenses

• Upload documents

• Pay fees

• Track application status

• Receive deficiency letters

• Download approved licenses

The online system has made the application process faster and more transparent.

Government Fees for MD-15 License

Government fees depend on factors such as:

• Medical device class

• Number of products

• Number of manufacturing sites

• Applicable CDSCO fee schedule

Businesses should verify the latest fee structure before submitting the application.

How Long Does It Take?

The approval timeline depends on:

• Device classification

• Completeness of documents

• CDSCO review

• Regulatory queries

Applications with complete documentation are generally processed more efficiently than incomplete submissions.

Validity of MD-15 License

An MD-15 License generally remains valid unless suspended, cancelled, or surrendered, provided the license holder continues to comply with applicable regulatory requirements and pays any required retention fees as prescribed under the Medical Devices Rules.

Common Reasons for Application Rejection

Many applications are delayed because of avoidable mistakes.

Common issues include:

• Incorrect documentation

• Missing technical information

• Invalid authorization letters

• Poor-quality scanned documents

• Incorrect device classification

• Labeling errors

• Incomplete application forms

• Delayed response to CDSCO queries

Reviewing the application carefully before submission can significantly improve the chances of timely approval.

Benefits of Getting an MD-15 License

Obtaining an MD-15 License offers several advantages:

• Legal import of medical devices into India

• Compliance with Indian regulations

• Faster customs clearance

• Improved business credibility

• Access to the Indian healthcare market

• Better trust among hospitals and distributors

• Reduced regulatory risks

Why Choose PSR Compliance?

Applying for an MD-15 License requires careful preparation and compliance with CDSCO requirements. Missing documents or incorrect information can delay the approval process.

PSR Compliance provides end-to-end assistance, including:

• Eligibility assessment

• Document preparation

• CDSCO SUGAM registration

• MD-14 application filing

• Regulatory guidance

• Query management

• Compliance support until license approval

Our team helps businesses complete the process smoothly while minimizing delays.

Conclusion

The MD-15 License is an essential regulatory requirement for businesses importing notified medical devices into India. It demonstrates compliance with the Medical Devices Rules, 2017 and helps ensure that only safe and quality medical devices reach the Indian market.

By understanding the application process, preparing the required documents, and submitting a complete application through the CDSCO SUGAM Portal, businesses can streamline the approval process and reduce unnecessary delays.

If you need professional assistance with your Medical Device Import License (MD-15 License), the experts at PSR Compliance can guide you through every stage—from document preparation to successful license approval.

Company Name: PSR Compliance

Phone: +91 7065883416

Email: support@psrcompliance.com

Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Website: https://www.psrcompliance.com/cdsco-md-15-license