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CDSCO Manufacturing License for Medical Devices in India

A CDSCO manufacturing license for medical devices is a mandatory government approval issued under India’s Medical Devices Rules, 2017 (MDR 2017). Any company that wants to manufacture medical devices in India for sale or commercial distribution must obtain this license. It is issued by the State Licensing Authority (SLA) under CDSCO oversight. Devices are classified into four risk classes — Class A, B, C, and D — and the license form differs accordingly (MD-5 for Class A/B and MD-9 for Class C/D). The CDSCO manufacturing license validity is 5 years, after which it must be renewed. Without this license, manufacturing medical devices in India is illegal under MDR 2017.

What is a CDSCO Manufacturing License for Medical Devices?

In India, the Central Drugs Standard Control Organization (CDSCO) is the national authority that regulates all aspects of medical device manufacturing, sales, and distribution. Under the Medical Devices Rules, 2017, every company that wants to produce medical devices for commercial purposes must have a valid CDSCO manufacturing license.

This license acts as your legal permission to operate a medical device manufacturing business in India. It confirms that your facility, processes, team, and quality management system all meet the required standards under Indian law. Think of it as your business’s regulatory passport in India’s medical device industry.

Important note: Even if you are only doing final assembly, packaging, or sterilization of imported components inside India, you still need a CDSCO manufacturing license. There is no exception to this rule under MDR 2017.

Who Issues the CDSCO Manufacturing License?

The CDSCO manufacturing license is issued by the State Licensing Authority (SLA) — the drug control department of your respective state. The SLA checks whether your facility, documentation, quality systems, and technical staff comply with MDR 2017. CDSCO at the central level supervises and co-ordinates this entire process to ensure national consistency in regulatory standards.

Medical Device Classification Under CDSCO

Before applying for a CDSCO license, you must know which class your medical device belongs to. Your device class determines the application forms, fees, inspection requirements, and the level of regulatory scrutiny your application will face.

Class	Risk Level	Application Form	License Form	Examples
Class A	Low Risk	MD-3	MD-5	Bandages, stethoscopes, examination gloves, thermometers
Class B	Low-Moderate Risk	MD-3	MD-5	Blood pressure monitors, syringes, IV sets, sutures
Class C	Moderate-High Risk	MD-7	MD-9	Orthopaedic implants, catheters, artificial heart valves
Class D	High Risk	MD-7	MD-9	Pacemakers, ventilators, heart-lung machines

Getting the device classification wrong is one of the most common reasons for application rejection or delays of several months. If you are unsure about your device class, TraccGlobal’s regulatory experts can classify your device correctly before you even begin the application process.

3 Phases of the CDSCO Manufacturing License Process

The CDSCO license process runs in three phases. Each phase has its own requirements, forms, and portal steps. You must complete all three phases in order to obtain a full commercial manufacturing license.

Phase I — Applicant Registration on the CDSCO Portal

In the first phase, your company registers on the CDSCO online portal and obtains login credentials. This is the foundation step that allows you to access all other applications on the portal.

Documents required at this stage:

Company address proof — certificate of incorporation, certificate of registration, IEC certificate, or MTNL/BSNL bill of the corporate site
ID proof of the authorised person (this can be any person apart from the management team who will be authorised for all types of registration)

After submitting the online form and uploading documents, you will receive a preliminary approval email from CDSCO. A follow-up email will then instruct you to submit a physical hard copy to the relevant authority.

Phase II — CDSCO Manufacturing Test License (Form MD-12)

A test license allows you to manufacture small quantities of medical devices for testing, evaluation, demonstration, or personnel training before you begin commercial production. This phase uses Form MD-12.

Steps involved in Phase II:

Apply via the CDSCO online portal
Fill Form MD-12 accurately with all required details
Upload the required supporting documents
Pay the prescribed fees through the portal payment gateway
Track the status of your application on the portal

Phase III — Full CDSCO Manufacturing License (MD-5 or MD-9)

This is the final commercial manufacturing license that gives you the legal permission to manufacture and sell medical devices in India at scale.

Steps involved in Phase III:

Submit online application on the CDSCO portal
Fill Form MD-3 for Class A and Class B devices, or Form MD-7 for Class C and Class D devices
Upload all technical documentation and GMP compliance documents
Pay applicable CDSCO manufacturing license fees through the portal
Undergo facility inspection by the State Licensing Authority
Receive Form MD-5 (Class A/B) or Form MD-9 (Class C/D) as your official license

Step-by-Step: How to Get a CDSCO Manufacturing License

Here is exactly what happens from start to finish, explained in plain and simple language.

Classify Your Medical Device
Identify whether your product is Class A, B, C, or D under MDR 2017. This single decision controls the entire application path — the forms you use, the inspection requirements, and the CDSCO manufacturing license fees you pay. Getting this right from day one saves months of potential rework and avoids early rejection.
Prepare Your Manufacturing Facility
Your facility must comply with Good Manufacturing Practices (GMP) as per MDR 2017. This includes cleanroom setup where required, a quality control area, proper storage conditions, calibrated equipment, and documented Standard Operating Procedures (SOPs). The State Licensing Authority will physically inspect your facility before issuing the license.
Build Your Technical Documentation
Prepare your technical file — product description, manufacturing process flow, device specifications, safety data, risk analysis, and biocompatibility data if applicable. For Class C and D devices, you will also need clinical evaluation data and a post-market surveillance (PMS) plan.
Register on the CDSCO Portal and Submit the Application
Create your company account on the CDSCO online portal (sugam.pharma.gov.in). Select the correct license type, fill in the application form, upload all documents, and pay the fees online through the portal’s payment gateway.
CDSCO and SLA Review of Your Application
The regulatory authority reviews your application and all uploaded documents. If anything is missing or unclear, you receive a deficiency letter asking for additional information or corrections. Responding quickly and accurately at this stage is critical to avoid unnecessary delays.
Manufacturing Facility Inspection
Inspectors from the State Licensing Authority visit your manufacturing plant to verify GMP compliance, documentation, infrastructure, equipment, and quality systems. If the facility passes the inspection, the process moves to final approval. If there are gaps, you will be given a specific period to correct the issues and re-inspect.
License Issued — You Can Now Manufacture Legally
Once approved, your CDSCO manufacturing license (MD-5 for Class A/B or MD-9 for Class C/D) is officially issued. You can now legally manufacture and sell medical devices in India. Remember — the CDSCO manufacturing license validity is 5 years, and you must apply for renewal before it expires to avoid any disruption to your business.

Documents Required for CDSCO Manufacturing License

Missing even one document can lead to application rejection or months of delay. Below is a comprehensive checklist of what you need to prepare before submitting your application.

General Documents Required for All Device Classes

Certificate of Incorporation or Partnership Deed
GST Registration Certificate
ID and address proof of the authorised person
Manufacturing site plan and complete facility layout
List of manufacturing equipment with calibration records
Site Master File (SMF)
Quality Manual (ISO 13485 aligned recommended)
List of technical and qualified personnel with their educational qualifications
SOPs for all manufacturing and quality control processes
Filled and signed Form MD-3 (for Class A/B) or Form MD-7 (for Class C/D)

Additional Documents Required for Class C and Class D Devices

Clinical evaluation data or performance data
Risk management file as per ISO 14971
Biocompatibility testing data as per ISO 10993
Design History File (DHF)
Post-Market Surveillance (PMS) plan
Sterilisation validation data (if the device requires sterilisation)

Document preparation is where most applicants lose time. Missing technical data, incorrect file formats, or incomplete SOPs are the top reasons CDSCO issues deficiency letters. TraccGlobal prepares your complete document package so you never face unnecessary rejections or delays. Get your documents reviewed — visit traccglobal.com

CDSCO Forms Explained — MD-3, MD-5, MD-7, MD-9, MD-12

The CDSCO portal uses specific forms for different stages and device classes. Here is a clear explanation of what each form does and when it is used.

Form MD-3 is the application form used to apply for a CDSCO manufacturing license for Class A and Class B medical devices for sale or distribution. You submit this form at the time of applying for your commercial license.

Form MD-5 is the actual license certificate issued to manufacturers of Class A and Class B medical devices. After your MD-3 application is reviewed and approved, you receive Form MD-5 — this is your official CDSCO manufacturing license document for low and low-moderate risk devices.

Form MD-7 is the application form used to apply for a manufacturing license for Class C and Class D medical devices — the higher-risk category that requires more rigorous review, detailed technical documentation, and thorough facility inspection.

Form MD-9 is the actual license certificate issued to manufacturers of Class C and Class D medical devices after their MD-7 application is reviewed and approved. This is the final document confirming your manufacturing authorisation for high-risk and critical medical devices.

Form MD-12 is the test license that allows you to manufacture small quantities of medical devices for testing, clinical evaluation, personnel training, or demonstration purposes. You typically need this before applying for the full commercial manufacturing license.

CDSCO Manufacturing License Fees and Validity

CDSCO Manufacturing License Validity

Your CDSCO manufacturing license is valid for 5 years from the date of issue. After 5 years, you must apply for renewal to continue manufacturing legally. Operating with an expired CDSCO license is a regulatory violation under MDR 2017 and can result in penalties, product seizure, and legal action by the authorities. It is strongly recommended to apply for renewal at least 3 to 6 months before your license expiry date to ensure there is no gap in your manufacturing operations.

CDSCO Manufacturing License Fees

Device Class	Application Form	License Form Issued	Fee Range
Class A and Class B	MD-3	MD-5	Lower fee tier (State-determined)
Class C and Class D	MD-7	MD-9	Higher fee tier (CDSCO + State)
Test License (all classes)	MD-12	Test License Certificate	Minimal fee (varies by state)

CDSCO manufacturing license fees are set by the Ministry of Health and Family Welfare and are subject to revision from time to time. Fees also vary slightly depending on the state in which you apply. For the exact current fee structure as per 2025–2026 CDSCO updates, contact TraccGlobal — our team provides a complete and transparent cost breakdown before you begin the application process, so there are no surprises.

How to Apply on the CDSCO Portal for a Manufacturing License

The CDSCO online portal (sugam.pharma.gov.in) is where all medical device manufacturing license applications are submitted in India. Here is a clear walkthrough of the portal process.

Create your company account on the CDSCO portal using your official business email address. Once registered, log in and navigate to the “Online Application” section.
Select “Medical Devices” and then “Manufacturing License” from the available options. Selecting the wrong application category is a very common error that results in immediate rejection — so verify this step carefully before proceeding.
Fill in the application form completely with all correct details about your manufacturing facility, quality control setup, technical personnel qualifications, and the specific medical devices you intend to manufacture.
Upload all required documents in the format and file sizes specified in the CDSCO portal guidelines. Incorrect file formats are a frequent cause of technical rejections.
Pay the CDSCO manufacturing license fees through the portal’s secure online payment gateway. Keep the payment confirmation for your records.
Submit your application and track its status regularly through the portal dashboard. Once the application is reviewed, inspected, and approved, your license will be issued digitally through the same portal and can be downloaded directly.

Why Choose TraccGlobal as Your CDSCO Manufacturing License Consultant?

Getting a CDSCO license without expert help means navigating complex regulatory requirements, confusing forms, and repeated back-and-forth with government authorities. A small documentation error or wrong device classification can cost you months of delay and additional expense. TraccGlobal takes all of that pressure off your plate so you can focus entirely on building and growing your medical device business.

Here is what TraccGlobal does for you as your CDSCO manufacturing license consultant:

Expert guidance from day one — We classify your device correctly under MDR 2017, prepare your complete documents, and handle all portal submissions so you do not waste time on avoidable mistakes.
All device classes covered — Whether it is a simple bandage (Class A) or a life-supporting ventilator (Class D), our team has deep experience handling all risk classes across multiple states in India.
GMP facility readiness support — We review your manufacturing facility against MDR 2017 and GMP requirements before the official SLA inspection, so you are always well-prepared and confident when inspectors arrive.
Fast deficiency response — If CDSCO issues a deficiency letter, our team responds quickly with exactly the right information and documents to keep your approval timeline on track without long delays.
Complete documentation service — Technical file, quality manual, SOPs, risk management file, design history file, site master file — we prepare everything according to CDSCO’s exact current requirements.
Post-license compliance support — We do not disappear after your license is issued. Our team continues to support you with renewals, amendments, post-market surveillance requirements, and ongoing regulatory compliance throughout the full 5-year license period and beyond.
Pan-India service — We work with medical device manufacturers across all Indian states and union territories, handling state-specific regulatory requirements smoothly without confusion or delays.

For more information and a free initial consultation, visit traccglobal.com

Frequently Asked Questions (FAQ) — CDSCO Medical Device Registration

What is a CDSCO manufacturing license for medical devices?

It is a mandatory legal approval under India’s Medical Devices Rules, 2017 (MDR 2017) that allows a company to manufacture medical devices in India for sale or commercial distribution. Without this license, manufacturing medical devices in India is not legally permitted under any circumstances.

Who issues the CDSCO manufacturing license in India?

The CDSCO license is issued by the State Licensing Authority (SLA) — the drug control department of your state — under the supervision and regulatory framework set by CDSCO at the central level of the Indian government.

What is the CDSCO manufacturing license validity period?

The CDSCO manufacturing license validity is 5 years from the date of issue. You must apply for renewal before it expires. Operating without a valid license is a regulatory violation under MDR 2017 and can attract serious penalties including product seizure.

What are the CDSCO manufacturing license fees?

CDSCO manufacturing license fees depend on the device class and the state in which you apply. Class A and B devices (MD-3 application) attract lower fees, while Class C and D devices (MD-7 application) attract higher fees. The fee structure is revised periodically by the Ministry of Health and Family Welfare. Contact TraccGlobal for the exact current fee schedule applicable to your specific device and state.

Do I need a CDSCO license for assembling or packaging imported components in India?

Yes, absolutely. If you are doing final assembly, packaging, labelling, or sterilisation of medical device components within India — even if all parts are imported — you still require a valid CDSCO manufacturing license. This is explicitly stated in MDR 2017 and there are no exemptions to this rule.

How long does it take to get a CDSCO manufacturing license?

The timeline typically ranges from 3 to 9 months depending on the device class, completeness of your documentation, state inspection scheduling, and how quickly deficiencies — if any — are resolved. Working with an experienced CDSCO manufacturing license consultant like TraccGlobal significantly reduces delays caused by documentation errors and slow deficiency responses.

Is ISO 13485 certification required for a CDSCO manufacturing license?

ISO 13485 is not a mandatory requirement under MDR 2017, but your Quality Management System (QMS) must comply with the Good Manufacturing Practices (GMP) specified in the rules. Having ISO 13485 certification significantly strengthens your application, makes the SLA facility inspection smoother, and shows regulators that your quality systems meet international standards.

What happens if my CDSCO manufacturing license expires?

Manufacturing or selling medical devices after your CDSCO license has expired is illegal under MDR 2017. It can result in financial penalties, product seizure, and serious legal consequences for your company and its directors. Always apply for renewal at least 3 to 6 months before your license expiry date to ensure zero disruption to your manufacturing and distribution operations.

Can a new startup apply for a CDSCO manufacturing license?

Yes. Any company incorporated in India, including a newly formed startup, can apply for a CDSCO manufacturing license as long as it meets the facility, documentation, and qualified technical staff requirements set out in MDR 2017. Many first-time applicants benefit greatly from working with a CDSCO manufacturing license consultant to avoid early-stage errors that waste time and money.

Is a separate CDSCO license needed for each medical device I manufacture?

Not necessarily a separate license, but each device or product type must be listed and covered under your manufacturing license. If you add a new device to your manufacturing portfolio later, you need to apply for an amendment to your existing license to include the new product. TraccGlobal can help you manage these amendments smoothly.

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