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CDSCO Medical Device Manufacturing License in India
Table of Content
- 1. INTRODUCTION
- 2. CDSCO and Its Regulatory Role
- 3. India CDSCO Medical Device Classification Guide
- 4. License under CDSCO: Application Forms, License Types & Authorities
- 5. Who Can Apply for CDSCO Medical Device Manufacturing License?
- 6. Mandatory Regulatory Checkpoints for Manufacturers Seeking CDSCO Certification
- 7. Documents Required for CDSCO Manufacturing License
- 8. CDSCO Manufacturing License Registration Process
- 9. Validity and Retention of CDSCO Manufacturing License
- 10. Importance of CDSCO Medical Device Registration
- 11. Why Choose Absolute Veritas as Your CDSCO Registration Consultant?
- 12. Get in Touch with Absolute Veritas
- 13. Our Blogs
- 14. Frequently asked questions (FAQ)
All medical devices manufactured in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) , also referred to as the Central Drug Control Organisation or Central Drugs Standard Control Organization. CDSCO functions under the Ministry of Health & Family Welfare, Government of India and acts as the national regulatory authority for drugs and medical devices.
The regulatory framework for medical devices is governed by the Medical Device Rules, 2017 (CDSCO). These rules ensure that medical devices manufactured, sold, or distributed in India comply with essential requirements of safety, quality, performance, and efficacy. Any manufacturer or entity dealing with medical devices or In-Vitro Diagnostic (IVD) devices must obtain a valid CDSCO medical device manufacturing license before starting operations.
Manufacturing, selling, or marketing medical devices without proper CDSCO registration or approval may result in regulatory action, CDSCO audit, suspension or cancellation of the CDSCO licence, penalties, or legal proceedings.
CDSCO and Its Regulatory Role
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India in coordination with different licensing authorities:
| Category | Description |
| State Licensing Authorities (SLA) | For low-risk and moderate-risk medical devices |
| Central Licensing Authority (CLA / CDSCO HQ) | For high-risk and critical medical devices |
This risk-based approach under CDSCO medical device rules 2017 ensures appropriate regulatory control while maintaining patient safety and compliance.
India CDSCO Medical Device Classification Guide
As per the Medical Device Rules, CDSCO 2017, medical devices manufactured in India are classified based on the level of risk associated with their intended use:
| Category | Description | Reference Items |
| Class A | Low-risk medical devices | Items such as surgical dressings, bandages, examination gloves, tongue depressors, hand-held surgical instruments, and thermometers (non-electrical) and many more. |
| Class B | Low to moderate-risk medical devices | Items include hypodermic needles, suction equipment, infusion sets, blood pressure monitoring devices, powered wheelchairs, and dental drills etc |
| Class C | Moderate to high-risk medical devices | Examples include infusion pumps, ventilators, dialysis equipment, bone fixation plates, intrauterine devices (IUDs), and anesthesia workstations and more. |
| Class D | High-risk or critical medical devices | Examples include heart valves, coronary stents, implantable defibrillators, pacemakers, heart-lung machines, and HIV or blood screening diagnostic kits etc. |
The CDSCO medical device classification determines:
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Applicable licensing authority (SLA or CDSCO HQ)
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Type of CDSCO online application and license form
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Inspection and CDSCO audit requirements
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Approval timeline and regulatory scrutiny level
License under CDSCO: Application Forms, License Types & Authorities
| Device Class | Application Form | License Issued | Licensing Authority |
| Class A & B | MD-3 | MD-5 | State Licensing Authority (SLA) |
| Class C & D | MD-7 | MD-9 | Central Licensing Authority (CDSCO) |
These licenses collectively form the CDSCO medical device manufacturing license system in India.
Who Can Apply for CDSCO Medical Device Manufacturing License?
The following entities are eligible to apply through CDSCO online registration:
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Indian medical device manufacturers
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Indian IVD medical device manufacturers
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Manufacturers with in-house production facilities
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Entities compliant with CDSCO medical device guidelines and quality standards
Applications are submitted through the official CDSCO online portal, commonly known as the CDSCO SUGAM portal.
Mandatory Regulatory Checkpoints for Manufacturers Seeking CDSCO Certification
Before applying for CDSCO certification or a manufacturing licence, manufacturers must ensure:
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Finalized medical device name, model, and variants
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Clearly defined intended use and indications
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Correct risk-based device classification
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Documented manufacturing process and workflow
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Implementation of ISO 13485 / ICMED certified Quality Management System
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Availability of qualified and experienced technical staff
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Manufacturing facility readiness as per GMP and CDSCO medical device regulation requirements
Documents Required for CDSCO Manufacturing License
Key documents required for CDSCO medical device registration include:
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Covering letter addressed to CDSCO or State Licensing Authority
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Company incorporation and constitutional documents
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Plant Master File (PMF)
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Device Master File (DMF) as per Medical Device Rules 2017 CDSCO
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ISO 13485 or ICMED certification
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Details of qualified technical personnel
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Manufacturing site layout plan
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Quality Management System (QMS) and SOP documentation
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Product labels and Instructions for Use (IFU)
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Batch test reports (where applicable)
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Proof of CDSCO online fee payment
CDSCO Manufacturing License Registration Process
Phase I – CDSCO SUGAM Portal Registration
Manufacturers must register on the official CDSCO SUGAM portal, also known as mdonline CDSCO or CDSCOMD online, for medical device licensing.
Steps include:
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CDSCO apply online through the SUGAM portal
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Selection of correct application form (MD-3 or MD-7)
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Entry of company, manufacturing site, and device details
Phase II – Application Submission
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Upload of PMF, DMF, ISO certificates, and declarations
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Submission of technical and regulatory documents
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Online payment of government fees as per device class
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Generation of CDSCO application reference number
Phase III – Technical Review & CDSCO Audit
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Application scrutiny by CDSCO or SLA
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Queries or clarification requests, if any
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Manufacturing site inspection or CDSCO audit
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Verification of GMP, infrastructure, and quality systems
Phase IV – Grant of CDSCO Manufacturing License
Upon successful review and inspection:
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MD-5 license issued for Class A & B devices
-
MD-9 license issued for Class C & D devices
This CDSCO registration certificate authorizes the legal manufacture and sale of medical devices in India.
Validity and Retention of CDSCO Manufacturing License
Validity
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MD-5 and MD-9 licenses have perpetual validity
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License remains valid subject to payment of retention fees every 5 years
Retention Requirements
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No annual renewal is required
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Retention fee must be paid before the end of each 5-year cycle
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Retention fee is equivalent to the fresh CDSCO license fee
Non-payment of retention fees may result in suspension, cancellation, or requirement of fresh CDSCO registration for medical devices.
Importance of CDSCO Medical Device Registration
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Legal authorization to manufacture medical devices in India
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Compliance with CDSCO medical device rules 2017
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Enhanced credibility and acceptance in domestic and export markets
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Eligibility for hospital supply and government tenders
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Reduced regulatory, legal, and compliance risks
Why Choose Absolute Veritas as Your CDSCO Registration Consultant?
Absolute Veritas is a trusted CDSCO registration consultant offering end-to-end support for CDSCO medical device manufacturing license and certification.
Our services include:
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Complete CDSCO manufacturing license assistance
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Device classification and regulatory strategy
-
PMF, DMF, QMS, and SOP documentation
-
CDSCO SUGAM portal filing and coordination
-
CDSCO audit and inspection support
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License issuance, retention, and post-approval changes
With extensive experience in CDSCO medical device registration, Absolute Veritas ensures a smooth, compliant, and timely approval process, enabling manufacturers to confidently establish and expand their presence in the Indian medical device market.
Get in Touch with Absolute Veritas
Let Absolute Veritas Guide You for CDSCO medical device registration.
Don’t let Process slow down your business. Contact Absolute Veritas today and let our experienced consultants handle the entire registration process for you. We’ll provide Complete CDSCO manufacturing license assistance ,saving you time, effort, and stress.
Connect with us now to get expert consultation and seamless CDSCO registration support across India. For more information please contact us at cs@absoluteveritas.com
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Frequently asked questions (FAQ)
What is a CDSCO medical device manufacturing license ?
A CDSCO medical device manufacturing license is a mandatory regulatory approval issued under the Medical Device Rules, 2017, that authorizes manufacturers to legally produce medical devices or IVDs in India while ensuring compliance with safety, quality, and performance standards.
Is CDSCO registration mandatory for all medical device manufacturers in India?
Yes, all manufacturers of medical devices and IVDs in India must obtain a valid CDSCO manufacturing license before commencing production, sale, or distribution, irrespective of device risk class.
Which authority issues the CDSCO manufacturing license?
The licensing authority depends on device classification. Class A and Class B devices are licensed by the State Licensing Authority (SLA), while Class C and Class D devices are regulated and licensed by the Central Licensing Authority (CDSCO HQ).
How are medical devices classified under CDSCO?
Medical devices are classified into Class A, B, C, and D based on the risk associated with their intended use. This classification determines the applicable license form, regulatory scrutiny level, inspection requirements, and approval timeline.
Who is eligible to apply for a CDSCO manufacturing license?
Indian manufacturers, Indian IVD manufacturers, contract manufacturers, and entities with compliant manufacturing facilities and quality systems are eligible to apply through the CDSCO SUGAM online portal.
Which application forms are required for CDSCO manufacturing licenses?
Manufacturers of Class A and B devices must apply using Form MD-3 and receive the license in Form MD-5, whereas manufacturers of Class C and D devices apply using Form MD-7 and receive approval in Form MD-9.
What are the key prerequisites before applying for a CDSCO manufacturing license?
Manufacturers must finalize device details, confirm correct classification, implement an ISO 13485 or ICMED-certified QMS, appoint qualified technical staff, and ensure manufacturing facilities comply with GMP and CDSCO regulatory requirements.
What documents are required for CDSCO medical device manufacturing license registration?
Essential documents include the Plant Master File, Device Master File, ISO 13485 or ICMED certificate, company incorporation documents, technical personnel details, site layout, SOPs, labeling and IFU, and proof of fee payment.
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