MD-18 License under CDSCO: Documents, Fees, and Approval Process
In India, the importation of medical devices is governed by the Medical Device Rules, 2017, under the regulation of the Central Drugs Standard Control Organization (CDSCO). All foreign manufacturers or India-based importers must secure the MD-18 License as part of their business objectives prior to marketing or selling medical devices in India.
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Understanding MD-18 License
In India, the importation of medical devices is governed by the Medical Device Rules, 2017, under the regulation of the Central Drugs Standard Control Organization (CDSCO). All foreign manufacturers or India-based importers must secure the MD-18 License as part of their business objectives prior to marketing or selling medical devices in India.
The MD-18 license is one that the CDSCO issues to importers under Form 18, which is specifically issued as formal permission to import notified medical devices into India.
What Is an MD-18 License?
The MD-18 License is a permission given by CDSCO to importers of medical devices, providing assurance that the medical device will meet quality, safety, and performance requirements as determined by the Indian regulatory authority.
This license is required for any organization or distributor intending to import Class A, B, C, or D medical devices for the Indian market.
Who Requires an MD-18 License?
An MD-18 License is required if you:
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An importer bringing medical devices into India.
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A foreign manufacturer appoints an Indian Authorized Agent to handle imports.
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A distributor or business importing finished medical devices for sale or supply.
What Documents are required to apply for an MD-18 license?
To apply for an MD-18 License under CDSCO, applicants must submit the following documents:
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Covering Letter specifying the purpose of the application.
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Form 18 – Application for import license of medical devices.
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Power of Attorney (POA) from the foreign manufacturer.
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ISO 13485 Certificate of the manufacturing site.
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Free Sale Certificate (FSC) issued by the National Regulatory Authority of the exporting country.
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Device Master File (DMF) and Plant Master File (PMF).
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Undertaking on Product Standards and Compliance.
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Labels, Product Inserts, and Packaging Details.
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Certificate of Market Authorization in other countries (if available).
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Import-Export Code (IEC) and company authorization documents.
MD-18 License Fee (Form 18)
The MD-18 License application fee depends on the device class and the number of devices you are applying for. In accordance with the current CDSCO guidelines:
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For Class A & B Devices: ₹1,000 per device + ₹1,000 per manufacturing site.
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For Class C & D Devices: ₹3,000 per device + ₹3,000 per manufacturing site.
(Fees are subject to updates as per CDSCO notifications.)
MD-18 License Approval Process
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Step 1: File the application online through the CDSCO SUGAM Portal.
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Step 2: Attach Form 18, supporting documents, and pay the applicable fees.
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Step 3: CDSCO reviews the application and may request clarifications or additional information.
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Step 4: Upon successful evaluation, CDSCO grants the MD-18 License to the importer/authorized agent.
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Step 5: The importer can then legally import, market, and distribute medical devices in India.
Validity & Renewal
The MD-18 License is valid until it is canceled or suspended, as long as the importer pays the license retention fee every five years and follows the CDSCO provisions.
Final Thought
Obtaining your MD-18 License under CDSCO is a must for any importer who wishes to import medical devices into India. There is a need for accuracy, understanding of document requirements, and compliance with the CDSCO standards. With Corpseed's expert team, businesses can obtain their Form 18 (MD CDSCO) license without delays - rest assured that your products will be legally allowed into India's booming medical device market.
