Medical Device Import Registration

Move Ahead is India’s trusted Medical Device regulatory partner providing complete support for medical device import license applications, renewals, and compliance under CDSCO (Central Drugs Standard Control Organization).

What is Medical Device Import Registration?

To operate legally in India’s growing medical device sector, every manufacturer or importer must apply for a medical device registration with CDSCO. At Move Ahead, we make this process simple, clear, and efficient. Our experts help you prepare and file your medical device license application, ensuring that all documents meet CDSCO’s standards. We monitor application status and handle queries or corrections directly with regulatory officers.

MD-15 : Pathway for Importing Global Medical Devices into India

Why You Need a CDSCO Medical Device Import License

Legal Authorization: Without it, manufacturing or selling is illegal under Indian law.
Market Credibility: Licensed devices build trust with healthcare professionals and customers.
Compliance: Aligns your operations with the Medical Device Rules, 2017.
Traceability: Every product has a verified medical device license number for easy identification.
Import Permission: Necessary for foreign manufacturers to legally distribute products in India.

Move Ahead helps you meet every requirement quickly and accurately — protecting your business from legal penalties and operational risks..

Apply Medical Device Import Registration (MD-15) in India

Any entity willing to import medical devices from a foreign manufacturer needs to apply for a CDSCO import license. At Move Ahead, we specialize in assisting you with product compliance to ensure a smooth registration and licensing process..

The MD-15 license, issued by the CDSCO, is essential for the import of medical devices into India and MAC is dedicated to managing regulatory process efficiently through the SUGAM portal, ensuring timely approvals. This license serves as a crucial gateway for the import and sale of both medical devices and in-vitro diagnostic (IVD) devices within the country, making it a mandatory requirement. Securing this license is the first critical step for foreign manufacturers entering the Indian market.

With evolving regulations and stringent compliance standards set by CDSCO, expert guidance is crucial for a smooth approval process. At Move Ahead, we streamline your India entry strategy by managing end-to-end regulatory requirements helping you achieve faster market access.

Our end-to-end registration process includes

Classification and identification of medical devices.
Preparing technical and administrative documentation.
Submitting the application on the SUGAM portal.
Coordinating with CDSCO for review and approval
Providing after-license assistance for renewals and audits.

Move Ahead guides you through every step of the medical device license application, ensuring accuracy and fast processing.

Documents Required for Medical Device License

Applying for a medical device license in India requires a set of mandatory documents to prove product quality, source, and company validity. Move Ahead ensures every document is accurate and ready for submission.

Application (Form MD-14)
Power of Attorney
Fee Challan
Copy of Wholesale License / Manufacturing License / Registration Certificate in Form MD-42 of the Authorized Agent
Copy of Free Sale Certificate
Device Master File

When you search for “CDSCO Medical Device Registration Near Me,” MoveAhead Compliance is your trusted, reliable choice in India.

CDSCO Medical Device Registration

Move Ahead offers CDSCO medical device registration services to clients across India, with strong support for manufacturers and importers in major cities. Whether your business is based in Delhi, Mumbai, Bengaluru, Chennai, or anywhere else, our team provides remote and on-site assistance. We act as your dedicated medical device regulatory partner, simplifying complex procedures into clear, actionable steps. Our experts help prepare the required forms, verify your documents, and file them through the SUGAM portal — the official CDSCO online platform.

Our nationwide presence ensures:

Quick support regardless of your business location
Transparent updates on your application status.
Coordination with local CDSCO office.
Continuous post approval compliance support

When you search for “CDSCO Medical Device Registration Near Me,” Move Ahead is your trusted, reliable choice in India.

Step-by-Step Guide for Foreign Manufacturers to Sell Medical Devices in India

How to sell medical devices in India as a foreign manufacturer?

Foreign manufacturers must follow specific CDSCO steps before selling devices in India. Move Ahead provides full support for medical device import and distribution licenses, ensuring quick market entry with complete compliance.

Fee Structure for Import License of Medical Devices

Medical devices are classified based on risk, and the import license fee varies accordingly:

Class A (excluding IVD devices):

Site fee:$1,000
Fee per distinct medical device:$50

Class B (excluding IVD devices):

Site fee:$2,000
Fee per distinct medical device:$1,000

Class C and Class D (excluding IVD devices):

Site fee:$3,000
Fee per distinct medical device:$1,000

Validity and Renewal of MD-15 license

The MD-15 license does not require a traditional renewal process, but timely payment of the retention fee is considered a form of regulatory renewal

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stays valid permanently, as long as the license retention fee is paid on time. This fee must be paid every 5 years from the date the license was issued, unless the license is suspended or cancelled by the Central Licensing Authority. The process is managed through the SUGAM portal, where license holders must also ensure that all other compliance requirements are up to date.

Move Ahead - your trusted guide for smooth and compliant medical device import registration.

Expert Guidance on Regulatory
Compliance CDSCO Liaison and Query Handlingl
Customized Support for Foreign Manufacturers
Accurate Device Classification & Regulatory Strategy
Ensure timely approvals and streamlined licensing processes

Contact MoveAhead for Medical Device Import Registration Today!

Delivering Regulatory Solutions for Seamless Medical Device Registration and Import in India backed by 14 years of expertise and reliable industry leadership

Our goal is simple — to help businesses obtain their medical device license in India without confusion or delay. Whether you’re a manufacturer, importer, or distributor, you must have the right medical device business license before selling or distributing any medical device product in India. Move Ahead helps your company meet every CDSCO requirement, submit the correct forms, and maintain a valid medical device license. We handle the end-to-end process — from document preparation to coordination with CDSCO — so you can focus on your business. As a trusted name in compliance services, Move Ahead provides transparent, reliable, and post approval compliance support to help you stay compliant at every stage.

Contact us today to get started:

011-41666016
support@moveahead.in
Your license, compliance, and peace of mind — all managed by MoveAhead Compliance.

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