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First Auditors platform is a technology-driven platform that offers specialized legal and financial advisory services in India.

CDSCO Medical Devices Loan License

We specialize in CDSCO Medical Devices Loan License services to help your business manufacture medical devices without owning a manufacturing facility. Our services include the following:

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01 Overview 02 Who Needs 03 Eligibility 04 Documents 05 Process 06 Authority & Fees 07 Validity 08 Rejection 09 How We Help 10 FAQ
Overview

CDSCO Medical Devices Loan License in India

A CDSCO Medical Devices Loan License allows manufacturers to manufacture medical devices using another entity's licensed manufacturing facility. This is particularly useful for companies wanting to manufacture medical devices without having their own manufacturing facility. The loan license enables businesses to enter the medical device market without significant capital investment in manufacturing infrastructure.

To obtain a CDSCO Medical Devices Loan License, the applicant must: Complete Form MD-8 (for Class C & D devices) or Form MD-4 (for Class A & B devices), Comply with all applicable regulations, and Enter into a mutual agreement with the other manufacturer. The loan license is governed under the Medical Device Rules, 2017.

CDSCO Medical Devices Loan License Services
Who Needs This Service

Is CDSCO Medical Devices Loan License the right fit for your business?

CDSCO Medical Devices Loan License is ideal for businesses that want to manufacture medical devices without owning a manufacturing facility.

  • Startups and new medical device companies
  • Companies without manufacturing facilities
  • Brand owners and contract manufacturers
  • Medical device distributors
  • Pharmaceutical companies diversifying into devices
  • Any business wanting to manufacture medical devices
Eligibility Requirements

Who can apply for CDSCO Medical Devices Loan License

Eligible Applicants
  • Companies with valid business registration
  • Entities with agreement with licensed manufacturer
  • Startups and new ventures
  • Brand owners
  • Contract manufacturing companies
  • Any entity meeting D&C Act requirements
Key Requirements
  • Valid business registration in India
  • Active bank account in the name of the business
  • Registered business address in India
  • GST Registration (mandatory)
  • PAN Card of the business
  • Agreement with a licensed manufacturing facility
Documents Required

Documents Required for CDSCO Medical Devices Loan License

Documents are grouped the way CDSCO reviews them — business documents, facility documents, and agreement documents.

Business Documents
  • Company registration certificate
  • PAN Card and GST Registration
  • Board resolution (for companies)
  • Identity proof of authorized signatory
Facility & Agreement Documents
  • Loan license agreement with manufacturer
  • Manufacturing facility details (Form MD-8 / MD-4)
  • Plant Master File (PMF)
  • Device Master File (DMF)
Compliance Documents
  • GMP Certificate of the manufacturing facility
  • ISO 13485 certification (if applicable)
  • Quality assurance documentation
  • Fee payment challan
Step-by-Step Procedure

CDSCO Medical Devices Loan License Process

Each stage is a real, sequential step through the CDSCO Medical Devices Loan License process under the Medical Device Rules, 2017.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your CDSCO Medical Devices Loan License requirements and business type.

02
2–3 working days

Document Collection & Verification

Submit all necessary documents for CDSCO Loan License. Our team verifies and completes the documentation.

03
2–3 working days

Application Form Preparation (MD-4 / MD-8)

Prepare the appropriate application form based on device classification (Class A/B: MD-4, Class C/D: MD-8) with all required details.

04
1–2 working days

Application Submission

Submit the application through the CDSCO SUGAM portal with the prescribed fee.

05
5–10 working days

Document Review & Evaluation

CDSCO reviews the application and verifies the submitted documents. Any queries are addressed promptly.

06
15–30 working days

Application Processing & Approval

CDSCO processes the application and issues the Loan License (Form MD-6 for Class A/B or MD-10 for Class C/D) upon approval.

07
1–3 working days

License Issuance

Upon approval, we receive the CDSCO Medical Devices Loan License and send a copy to you via email or courier.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health and Family Welfare.

Estimated Processing Period

Typically 20–40 working days from complete document submission, depending on the authority's workload.

Certificate Issued

CDSCO Medical Devices Loan License (Form MD-6 or MD-10) with unique registration number and validity period.

Fee Structure

Government fee varies based on device classification. Professional fee quoted upfront by First Auditor.

ComponentClass A/BClass C/D
Site Manufacturing Fee ₹5,000 ₹50,000
Per Device Fee ₹500 ₹1,000
Site Inspection Fee (per man day) ₹12,500 ₹20,000
Professional fee Quoted upfront, one-time

Government fees are prescribed by CDSCO. Our team quotes both components separately before you proceed, with nothing added later.

Validity & Renewal

How long is the CDSCO Medical Devices Loan License valid?

CDSCO Medical Devices Loan License is typically valid for a period of 5 years. To maintain the license, businesses must:

  • Apply for renewal before the expiry date
  • Submit updated documents and fees
  • Maintain proper product records and documentation
  • Report any changes in manufacturing facility or agreement
  • Comply with all CDSCO regulations and guidelines
  • Maintain quality standards for medical devices
  • Submit annual returns if required
Common Reasons for Rejection

What causes CDSCO to reject a loan license application

  • Incomplete or incorrect application form submission
  • Missing or invalid agreement with manufacturer
  • Non-compliance with Medical Device Rules, 2017
  • Missing Device Master File (DMF)
  • Missing Plant Master File (PMF)
  • Invalid GMP certification of manufacturing facility
  • Incomplete business registration documents
  • Missing fee payment challan
  • Non-compliance with CDSCO regulatory requirements
How First Auditor Assists

One team, from document collection to license issuance

We manage every step, document, and follow-up with CDSCO so you can focus on your medical device business.

Eligibility & Document Check

We verify your eligibility and ensure all required documents are complete and valid.

Application Preparation

Complete application form (MD-4/MD-8) drafting and verification to ensure error-free submission.

Device Classification Guidance

Consulting on medical device classification (Class A, B, C, D) and specific CDSCO requirements.

Application Filing

Complete CDSCO loan license application filing through the SUGAM portal.

Query Handling

We respond to all queries from CDSCO on your behalf.

Compliance Calendar

A full compliance schedule including renewal reminders and annual return filing.

Dedicated Support

A single point of contact for questions throughout the entire process.

Frequently Asked Questions

FAQ

A CDSCO Medical Devices Loan License allows a company to manufacture medical devices at another entity's licensed manufacturing facility. This is beneficial for companies that do not have their own manufacturing facilities but wish to manufacture medical devices. The license is governed under the Medical Device Rules, 2017.

Any company or entity that intends to manufacture medical devices using another company's licensed manufacturing premises can apply for a loan license. The primary manufacturer must already hold a valid CDSCO manufacturing license. Startups, brand owners, and contract manufacturers are common applicants.

A Manufacturing License allows the licensee to produce medical devices at their own facility, while a Loan License allows one company to use another licensed facility for manufacturing. Both licenses ensure compliance with safety, efficacy, and quality standards as per the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017.

For Class A and B medical devices: Form MD-4 (Application) and Form MD-6 (License). For Class C and D medical devices: Form MD-8 (Application) and Form MD-10 (License). These forms must be submitted through the CDSCO SUGAM portal.

Documents required include company registration certificate, PAN Card, GST registration, loan license agreement with manufacturer, Device Master File (DMF), Plant Master File (PMF), GMP Certificate of the manufacturing facility, ISO 13485 certification (if applicable), and fee payment proof.

The process typically takes 20 to 40 working days, depending on the completeness of the application, the documentation provided, and the workload of the CDSCO authorities.

For Class A/B devices: Site manufacturing fee ₹5,000 and per device fee ₹500. For Class C/D devices: Site manufacturing fee ₹50,000 and per device fee ₹1,000. Site inspection fees: ₹12,500 per man day (minimum 2 man days) for Class A/B and ₹20,000 per man day for Class C/D.

To renew your CDSCO Loan License, you must submit a renewal application along with updated documents and fees before the expiration date. Ensure all information is accurate and up-to-date to avoid delays in processing.

The CDSCO Medical Devices Loan License is typically valid for 5 years. It must be renewed before the expiry date to continue manufacturing medical devices legally.

You can get assistance with CDSCO Medical Devices Loan License by contacting our expert team. We will guide you through the entire process, including document preparation, application filing, and follow-ups with CDSCO.
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017 and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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