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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 Manufacture License

We specialize in CDSCO Medical Devices Manufacture License services to help your business manufacture quality medical devices in compliance with Indian regulations. 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 Manufacture License in India

The CDSCO (Central Drugs Standard Control Organization) Medical Devices Manufacture License is an official authorization required for companies that wish to manufacture medical devices in India. The license is governed under the Medical Devices Rules, 2017, which classify medical devices into different categories based on their risk levels.

The CDSCO Medical Devices Manufacture License ensures that manufacturers comply with quality, safety, and regulatory standards. It is mandatory for all manufacturers intending to produce medical devices for sale, distribution, or export in India. The license covers all classes of medical devices from Class A (low risk) to Class D (high risk).

CDSCO Medical Devices Manufacture License Services
Who Needs This Service

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

CDSCO Medical Devices Manufacture License is mandatory for any business manufacturing medical devices in India.

  • Medical device manufacturers
  • Contract manufacturers
  • Class A, B, C, and D device manufacturers
  • Export-oriented manufacturing units
  • Pharmaceutical companies diversifying into devices
  • Any business manufacturing medical devices
Eligibility Requirements

Who can apply for CDSCO Medical Devices Manufacture License

Eligible Applicants
  • Companies with valid business registration
  • Manufacturing facilities in India
  • Entities with quality management systems
  • Startups and new ventures
  • Existing pharmaceutical manufacturers
  • 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
  • Manufacturing facility with GMP compliance
Documents Required

Documents Required for CDSCO Medical Devices Manufacture License

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

Business Documents
  • Company registration certificate
  • PAN Card and GST Registration
  • Certificate of Incorporation
  • Import-Export Certificate (if applicable)
Facility Documents
  • Site plan and key plan blueprint
  • Plant Master File (PMF)
  • Device Master File (DMF)
  • Address proof of manufacturing facility
Quality Documents
  • ISO 13485 certification
  • GMP compliance documentation
  • Quality management system details
  • Quality control procedures
Step-by-Step Procedure

CDSCO Medical Devices Manufacture License Process

Each stage is a real, sequential step through the CDSCO Medical Devices Manufacture 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 Manufacture License requirements and business type.

02
2–3 working days

Document Collection & Verification

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

03
2–3 working days

Application Form Preparation (Form MD-3 / MD-7)

Prepare the appropriate application form based on device classification (Class A/B: MD-3, Class C/D: MD-7) with all required details.

04
1–2 working days

Application Submission

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

05
10–15 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 Manufacture License (Form MD-5 for Class A/B or MD-9 for Class C/D) upon approval.

07
1–3 working days

License Issuance

Upon approval, we receive the CDSCO Medical Devices Manufacture 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 6–9 months from implementation to certification, depending on the device class and authority's workload.

Certificate Issued

CDSCO Medical Devices Manufacture License (Form MD-5 or MD-9) 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
Amendment/Variation Fee ₹2,000 – ₹5,000
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 Manufacture License valid?

CDSCO Medical Devices Manufacture 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 product line
  • Comply with all CDSCO regulations and guidelines
  • Maintain GMP standards for medical devices
  • Submit annual returns if required
Common Reasons for Rejection

What causes CDSCO to reject a manufacture license application

  • Incomplete or incorrect application form submission
  • Missing or invalid business registration documents
  • Non-compliance with Medical Device Rules, 2017
  • Missing Device Master File (DMF)
  • Missing Plant Master File (PMF)
  • Invalid GMP certification or ISO 13485
  • Incomplete facility details or site plan
  • 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 manufacturing business.

Eligibility & Document Check

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

Application Preparation

Complete application form (MD-3/MD-7) 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 Manufacture 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

The CDSCO Medical Devices Manufacture License is a mandatory certification issued by the Central Drugs Standard Control Organization (CDSCO) in India. It permits manufacturers to produce medical devices for sale, distribution, or export in India, ensuring compliance with quality, safety, and regulatory standards as per the Medical Devices Rules, 2017.

Manufacturers intending to produce Class A, B, C, or D medical devices in India are required to obtain this license. It applies to all manufacturers, including those of in-vitro diagnostics (IVDs) and medical equipment.

Medical devices are classified into four categories based on risk: Class A (Low Risk) - simple devices like tongue depressors; Class B (Low to Moderate Risk) - dental tools and syringes; Class C (Moderate to High Risk) - diagnostic imaging equipment; and Class D (High Risk) - implantable devices like stents and pacemakers.

For Class A and B medical devices: Form MD-3 (Application) and Form MD-5 (License). For Class C and D medical devices: Form MD-7 (Application) and Form MD-9 (License). These forms must be submitted through the CDSCO SUGAM portal.

Documents required include company registration certificate, PAN Card, GST registration, Plant Master File (PMF), Device Master File (DMF), ISO 13485 certification, GMP compliance documentation, site plan, quality control procedures, and fee payment proof.

The process typically takes 6 to 9 months, depending on the class of the medical device, the completeness of the application, 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 for Class A/B and ₹20,000 per man day for Class C/D. Amendment fees range from ₹2,000 to ₹5,000.

No, it is illegal to manufacture medical devices in India without a valid CDSCO license. Violating this can lead to severe penalties, including legal actions, fines, suspension of manufacturing activities, and confiscation of products.

To renew your CDSCO Manufacture 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.

You can get assistance with CDSCO Medical Devices Manufacture 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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