CDSCO MD-3 Endorsement

The lifecycle management of imported medical devices in India is mainly regulated by the CDSCO MD-3 endorsement. It permits importers to lawfully extend or alter the scope of an existing MD-14 import licence and is governed by the Medical Device Rules, 2017. This includes any modifications authorised by the Central Drugs Standard Control Organisation (CDSCO) or the addition of new devices, manufacturing facilities, or product models.

This guide covers eligibility, documentation, application procedures, deadlines, costs, and compliance risks for MD-3 endorsement in an understandable and useful way. 

What Is CDSCO MD-3 Endorsement?

CDSCO MD-3 endorsement is a regulatory permit granted by the Central Licensing Authority which permits modifications or additions to an already issued MD-14 Import License. It is obligatory when an importer plans to expand the scope of an already existing license without requesting a new one. MD-3 is the official authorization to modify what has already been approved.

This approval is usually applied when new medical equipment is launched by the existing producer, when extra manufacturing locations are introduced, or alternative and models of an authorized device must be added. Rather than restarting the complete licensing process, MD-3 provides continuity with regulatory controls.

Notably, MD-3 is not independent. It is connected to a valid MD-14 license, and is also granted with the same compliance framework. MD-3 is used by CDSCO to monitor product expansions and maintain the safety, quality, and traceability. For importers, it is an organized, compliant way of expanding their portfolio without affecting their operations.

For the medical device importers in India, the MD-3 endorsement has a practical and strategic role in ensuring compliance while growing business operations. It provides controlled growth under an existing import license and ensure that every official change is strictly recognised by CDSCO.

• Continuity of Import License: MD-3 also enables importers to introduce new devices, models, or manufacturing details, without impacting the validity of the present MD-14 license, confirming continuous approvals and smooth continuation of import activities.
• Faster Portfolio Expansion: MD-3 does not require a new import license and works significantly faster to get regulatory approval, which enables importers to bring more medical devices to the Indian market.
• Reduced Regulatory Burden: The MD-3 process reduces paper work and government charges that are incurred on specific addition that is being requested, thus making the compliance simpler and more manageable as compared to the broad needs of a new MD-14 application.
• Operational flexibility: MD-3 allows businesses to make changes to product enhancements, new product variants or new manufacturing processes without delay or uncertainty in operations due to regulatory interruptions.
• Protection from Compliance Risk: MD-3 also guarantees that all imported devices are officially approved, which avoids any customs detention, regulatory objections, fines, and similar enforcement actions arising due to the addition of  unapproved products.
• Accurate Regulatory Records: MD-3 ensures that CDSCO maintains current, transparent documentation of all approved medical devices under the importer’s license, which promotes audits, inspections, and long-term regulatory compliance.

The importers that already have a valid MD-14 import license and desire to modify it within its permitted scope are required to fill the CDSCO MD-3 form. This is normally the case with Indian Authorized Agents signifying foreign manufacturers who intend to bring more medical devices under the same regulation.

When a business decides to grow its medical device portfolio often meet MD-3 when introducing new product versions, improved model versions, or accessories to an already approved medical device. Also, where a manufacturer installs a new manufacturing plant or relocates the production to another approved facility, MD-3 becomes necessary.

The MD-3 Form should also be submitted by the importers when CDSCO-approved changes ensue in device specifications that do not warrant a new license yet such alterations need to be recognized by the regulatory authorities. Any additions that affects the original license information while remaining within the same risk category usually comes under MD-3 endorsement.

Eligibility Criteria for Form MD-3

In order to apply to Form MD-3 the applicant must already be working within the CDSCO regulatory framework and requesting approved additions to an existing import license. The eligibility focuses on continuity of compliance rather than on a new authorization, making sure that only eligible importers seek this endorsement.

• The applicant must hold a valid and active MD-14 medical device import license
• The proposed addition must fall within the approved scope of Medical Device Rules, 2017
• The medical devices must be notified and regulated by CDSCO in India
• Manufacturer quality certifications and regulatory approvals must remain current and valid
• The Indian Authorized Agent must be officially registered and recognized by CDSCO

The MD-14 license and MD-3 endorsement are different yet closely related in the CDSCO regulations. The MD-14 is the main import license which will provide the legal right to import certain medical devices into India. It is a complete regulatory assessment of the device safety, quality systems, manufacturing premises and compliance documents.

Instead, MD-3 is not a license in itself. It is an approval which is given against an already existing MD-14 license in the case of any changes or additions needed. Whereas MD-14 lays down the right to import, MD-3 alters or expands that right in a regulated manner. MD-14 is used once for initial approval, but MD-3 can be utilized several times throughout the license lifecycle.

Understanding this difference is crucial, as applying for the wrong form may result in delays, rejection, or unnecessary regulatory onus.

The application of MD-3 endorsement needs specific documentation that clearly demonstrates the recommended addition or alteration under an already existing import license. Submitting the correct and updated documents will prevent the regulatory inquiries and facilitate easier inspection by the CDSCO authorities. Some of the key documents are:

• Copy of valid MD-14 medical device import license
• Covering letter detailing the purpose and scope of the MD-3 request
• Device details including models, variants, or additional products proposed
• Updated Device Master File or relevant technical documentation
• Manufacturer’s authorization letter issued to the Indian Authorized Agent
• Valid quality certifications such as ISO 13485
• Declaration and undertaking as per CDSCO requirements

The MD-3 application process is a systematic regulatory framework which enables approved additions under a current import license without interfering with the existing approvals. The applications can be submitted through the CDSCO SUGAM by entering the valid credentials to log in. Necessary documents must be uploaded. The following is the step-by-step process:

• Eligibility assessment: The importer ensures that the proposed addition is eligible as MD-3 as per the Medical device Rules, 2017 by evaluating whether the addition is within the scope of the already existing MD-14 license.
• Document compilation: All required technical documents, quality certifications, and authorization letters related to the new device, model, or manufacturing detail are carefully prepared to support the application.
• Online submission: Form MD-3 is submitted through the CDSCO SUGAM portal, with correct linkage to the active MD-14 license and complete uploading of supporting documentation.
• Fee payment: The applicable government fees for MD-3 endorsement are paid online as per CDSCO guidelines, depending on the nature and number of additions requested.
• Regulatory review: CDSCO examines the application and may raise queries for clarification or additional information, which should be addressed promptly to avoid processing delays.
• Grant of endorsement: Once the evaluation is successfully completed, CDSCO issues the MD-3 endorsement, formally extending the scope of the existing MD-14 import license.

The fee for MD-3 endorsement is prescribed under the Medical Device Rules, 2017 and varies based on the nature of the change. Typically, fees apply per additional device or manufacturing site. CDSCO may revise fee structures periodically, so applicants should always refer to the latest official notification before submission to avoid discrepancies.

Timeline for Approval of Form MD-3 Endorsement

Under normal conditions, MD-3 endorsement approval requires about 30-60 working days. The time period varies depending on the document accuracy, the complexity of the change, and the CDSCO's workload. Applications with incomplete documentation or inconsistencies in the regulations tend to experience extended review periods or additional queries.

The CDSCO MD-3 license stays valid as long as the underlying MD-14 license is active. It does not have an expiry date of its own. Any renewal, suspension, or cancellation of MD-14 will automatically affect the MD-3 endorsement. To remain valid, importers should ensure that they are in constant compliance.

Common Reasons for CDSCO MD-3 Endorsement Rejection

MD-3 endorsement applications are often rejected due to avoidable compliance gaps rather than complex regulatory issues. Most rejections arise from documentation errors, incorrect form usage, or misalignment with the scope of the existing import license.

• Submission of incomplete, outdated, or inconsistent technical documents that do not adequately support the proposed addition under the existing MD-14 license.
• Applying for MD-3 endorsement when the proposed change actually requires a fresh MD-14 import license as per Medical Device Rules, 2017.
• Mismatch between the devices or manufacturers listed in the MD-3 application and the approved scope of the existing MD-14 license.
• Expired or invalid manufacturer authorisation letters, quality certifications, or regulatory approvals submitted with the application.
• Incorrect medical device classification or risk category leading to regulatory inconsistency and additional scrutiny by CDSCO authorities.
• Errors in online submission, including incorrect tagging of devices or manufacturing sites on the CDSCO SUGAM portal.

Corpseed is a leading consulting firm that helps medical device importers navigate CDSCO regulations with clarity and confidence. When it comes to MD-3 Form and CDSCO Form MD-3, our focus is not just on filing an application, but on ensuring that your regulatory expansion is accurate, compliant, and approved without unnecessary delays.

• Expert Guidance: Our regulatory specialists explain when MD-3 endorsement is required, how it differs from MD-14, and whether your proposed addition fits within CDSCO Form MD-3 eligibility, helping you take the right regulatory approach from the start.
• Accurate Document Preparation: From reviewing your existing MD-14 license to preparing device details, manufacturer authorizations, and technical documents, we ensure that every submission under CDSCO Form MD-3 is complete and error-free.
• End-to-End Support: We manage the entire MD-3 endorsement process, including drafting, online submission on the CDSCO SUGAM portal, fee coordination, query handling, and regular follow-ups with authorities until approval is granted.
• Customized Compliance: Whether you are adding new devices, variants, or manufacturing sites, our approach is tailored to your specific business model, product category, and regulatory obligations under the Medical Device Rules, 2017.
• Ongoing Regulatory Assistance: Beyond MD-3 approval, we continue to support you with future amendments, renewals linked to MD-14, regulatory updates, and compliance planning to ensure long-term adherence to CDSCO requirements.