India's Trusted CDSCO Compliance Partner

Expert Medical Device Regulatory & Compliance Solutions

Your trusted partner for CDSCO registration, licensing, and end-to-end compliance support in India — helping manufacturers, importers, and distributors achieve faster approvals with accuracy and efficiency.

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Aligned with CDSCO NSWS MDR 2017 ISO 13485
500+
Devices Registered
10+
Years Experience
98%
Success Rate
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Newsroom

Latest Regulatory Updates

Stay updated with CDSCO notifications, regulatory changes, and compliance requirements.

Regulatory Update

CDSCO Updates MDR 2017 Guidelines for Class C Devices

Stay updated with the latest regulatory changes affecting medical device manufacturers in India.
Compliance

New Import License Requirements Effective Q1 2025
Clinical Affairs

Clinical Trial Regulations: What Manufacturers Need to Know
PMS

Post-Market Surveillance Requirements Under MDR 2017
News

Fast-Track Approval Process for Innovative Medical Devices

Licensing

CDSCO Medical Device License & Registration

Navigate India's medical device regulatory framework with confidence.

Click your device type

MD 5 CDSCO License for manufacturing Class A & B Medical Devices

MD 5 license is required to manufacture class A & B medical devices. A fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license will be issued by the State Licensing Authority.

Get CDSCO MD5 License >

MD 9 CDSCO License for manufacturing Class C & D Medical Devices

MD 9 license is required to manufacture class C & D medical devices. A fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required. The license will be issued by the Central Licensing Authority.

Get CDSCO MD9 License >

CDSCO Test License for Medical Devices

CDSCO grants the test license for manufacturing small quantities of medical devices for testing, clinical research, and demonstration purposes. CDSCO will grant the test license for manufacturing medical devices in India under MD-13.

Get CDSCO Test License >

CDSCO Loan License for Medical Devices

Manufacturers who do not have a medical device manufacturing facility can apply for the CDSCO loan license. These manufacturers will have to manufacture their devices in the facility of another medical device manufacturer. The loan license will be granted provided the other manufacturer manufactures the same product as the licensee.

Get CDSCO Loan License >

License Forms

CDSCO Licensing Forms Under MDR 2017

Tap any license to connect with our expert.

Manufacturing Licenses

Import Licenses

Test & Clinical Investigation Licenses

Wholesale & Sale of Medical Devices

CDSCO EU MDR USFDA

Who we are

About Shauryaa MedTech Regulatory Solutions

Shauryaa is a specialized regulatory consultancy focused on medical device compliance under CDSCO and MDR 2017. We support companies in achieving timely approvals through structured regulatory strategies and expert documentation.

⚡

Mission

To simplify regulatory compliance and enable faster market access for safe and effective medical devices.

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Vision

To be recognized as a trusted regulatory partner delivering reliable and compliant solutions.

Why choose us

  • ✓ Experienced regulatory professionals (15+ years expertise)
  • ✓ End-to-end CDSCO support
  • ✓ High approval success rate
  • ✓ Customized regulatory strategies
  • ✓ Dedicated and responsive support

Core capabilities

Everything you need for CDSCO compliance

› CDSCO & NSWS Registrations
› Medical Device Applications (MD-3 to MD-41)
› Post-Approval Changes (PAC)
› DMF, PMF, QSM, SOP Documentation
› ISO 13485 Compliance & MR Function Guidance

What we do

Our Services

Comprehensive regulatory solutions tailored to your medical device portfolio

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CDSCO Registration

Complete end-to-end CDSCO medical device registration and import license services for Class A, B, C & D devices.

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🏭

Manufacturing License

Assistance with MD5 and MD9 manufacturing license applications for domestic medical device manufacturers.

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Clinical Trials Support

Expert guidance for clinical investigation applications, ethics committee approvals, and trial management for medical devices.

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Regulatory Strategy

Strategic regulatory pathway planning, gap analysis, and compliance roadmap development for your product portfolio.

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📄

Technical Documentation

Preparation of technical files, risk management documentation, and IFU in compliance with MDR 2017 requirements.

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📊

Post-Market Surveillance

Ongoing compliance monitoring, vigilance reporting, PSUR preparation, and regulatory intelligence services.

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How we work

Our Regulatory Process

A clear, structured path from first conversation to license in hand.

1

Requirement Discussion

2

Device Classification

3

Documentation Preparation

4

Application Submission

5

Query Handling

6

Approval & License Issuance

Questions

Frequently Asked Questions

What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) is India's national regulatory authority for medical devices and pharmaceuticals.
What documents are required?
Typically PMF, DMF, ISO certification, FSC, and supporting technical documentation — the exact set depends on your device class.
How long does approval take?
Timelines vary depending on the device class and the quality and completeness of the submission.
How to identify device class?
Device class is determined based on the intended use and the associated risk category (Class A to D).

Get in touch

Book a Consultation

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WHAT YOU WILL GET

✓ Device classification support ✓ Documentation checklist ✓ Regulatory roadmap ✓ Timeline estimation
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