Medical Device Registration in Rajasthan

CDSCO & Rajasthan State Licensing Authority (Form MD-3, MD-5, MD-7, MD-9, MD-14 & MD-15) under Medical Devices Rules, 2017

Are you a medical device manufacturer, importer, or IVD kit developer in Jaipur, Jodhpur, Udaipur, Kota, Bhiwadi, Neemrana, Alwar, or anywhere in Rajasthan seeking CDSCO and State Licensing Authority (SLA) registration under the Medical Devices Rules (MDR), 2017? Get complete professional support for risk-based device classification (Class A, B, C, D & IVD), CDSCO SUGAM portal (`cdscomdonline.gov.in`) online filing, ISO 13485 Quality Management System (QMS) audit, Device Master File (DMF) and Plant Master File (PMF) compilation, NABL lab test report clearance, and MD Manufacturing / Import License Grant with Shree Meeracorp.

What's Included?

✓ Risk-Based Device Classification (Class A, B, C, D & IVD Kits)

✓ CDSCO SUGAM Portal (`cdscomdonline.gov.in`) Account Creation & E-Filing

✓ Device Master File (DMF) & Plant Master File (PMF) Dossier Drafting

✓ ISO 13485 QMS Cleanroom Audit & Factory Quality Inspection Prep

✓ Form MD-3 / MD-5 (Class A & B) SLA State License Application

✓ Form MD-7 / MD-9 (Class C & D) & Form MD-14 / MD-15 Import License Grant

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Expert Assistance
Professional Support

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CDSCO License Class A, B, C & D Devices

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SUGAM Portal Form MD-5 / MD-9 Filing

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ISO 13485 QMS Factory Audit Clearance

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Medical Device Registration Rajasthan

Medical Device Registration in Rajasthan is regulated under the Medical Devices Rules (MDR), 2017 by the Central Drugs Standard Control Organization (CDSCO - Ministry of Health and Family Welfare) and the State Licensing Authority (Rajasthan Drugs Control Organization).

Mandatory Registration for All Notified Medical Devices & IVD Diagnostics
Class A & Class B Devices Licensed by Rajasthan State Licensing Authority (Form MD-5)
Class C & Class D Devices Licensed by CDSCO Central Authority (Form MD-9)
Imported Devices Registered via Form MD-15 on SUGAM Portal
Mandatory ISO 13485 QMS Certification & Cleanroom Facility Audit

What is Medical Device Registration in Rajasthan?

Under the Medical Devices Rules, 2017, medical devices in India are categorized based on risk parameters: Class A (Low Risk, e.g., surgical bandages, wheelchairs), Class B (Low-Moderate Risk, e.g., hypodermic needles, suction pumps), Class C (Moderate-High Risk, e.g., ventilators, hemodialysis machines), and Class D (High Risk, e.g., cardiac stents, pacemakers, IVD HIV kits).

No entity in Rajasthan can manufacture, import, or distribute medical devices without obtaining the requisite Form MD-5 (State SLA) or Form MD-9 (CDSCO CLA) license. Manufacturers must compile a Device Master File (DMF), Plant Master File (PMF), establish an ISO 13485 Quality Management System (QMS), and conduct sample product testing in NABL accredited labs.

Shree Meeracorp assists medical device manufacturers, pharma units, and importers in Jaipur, Bhiwadi, Neemrana, Kota, Udaipur, and all Rajasthan districts with risk classification, SUGAM portal filing, ISO 13485 compliance audits, DMF/PMF dossier preparation, and CDSCO/SLA license grants.

Why Apply?

Benefits of Medical Device Registration in Rajasthan

Obtaining CDSCO medical device registration legalizes manufacturing and import operations, enables sales to government hospitals, and unlocks global export markets.

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100% Legal Work & Distribution Compliance

Legally authorizes manufacturing, packaging, importing, and wholesale distribution of medical devices across Rajasthan and India.

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Government Hospital & Tender Eligibility

A valid CDSCO MD license is a compulsory pre-qualification requirement for participating in Rajasthan Medical Services Corporation (RMSCL), AIIMS, and Central Ministry hospital tenders.

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Customs Import Clearance (Form MD-15)

Enables Indian importers to clear imported medical devices smoothly at Customs air/seaports without cargo detention or NOC rejection.

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ISO 13485 Quality Certification

Implementing CDSCO Fifth Schedule QMS norms elevates product safety, lowers defect rates, and builds healthcare provider trust.

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Global Export Opportunities

Holding a CDSCO Manufacturing License allows Rajasthan medical device makers to apply for Free Sale Certificates (FSC) to export globally.

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Protection from Seizure & Prosecution

Shields manufacturers and importers against product seizures, plant closures, and criminal penalties under the Drugs & Cosmetics Act, 1940.

Checklist

Documents Required for Medical Device Registration in Rajasthan

Required documentation for compiling Device Master File (DMF) & Plant Master File (PMF) on SUGAM portal:

✓ PAN Card and Aadhaar Proof of Applicant / Directors / Partners

✓ Active GST Registration Certificate & Wholesale Drug License (Form 20B/21B, if applicable)

✓ Proof of Manufacturing Facility Premises in Rajasthan (RIICO Allotment / Lease Deed / Factory License)

✓ Plant Master File (PMF) detailing factory layout, cleanroom ISO classification, and HVAC air handling units

✓ Device Master File (DMF) specifying design, raw materials, manufacturing process, risk analysis, and shelf life

✓ ISO 13485 Quality Management System (QMS) Certificate for Manufacturing Site

✓ Product Test Reports from a NABL Accredited / CDSCO Approved Testing Laboratory

✓ Qualification & Experience Credentials of Technical Competent Persons (Quality Assurance & Production)

✓ Product Packaging Artwork, Instruction for Use (IFU) Leaflet, and Material Safety Data Sheet (MSDS)

✓ Power of Attorney (PoA) Executed in Favor of Authorized Indian Agent (For MD Import Licenses)

✓ Free Sale Certificate (FSC) & Certificate of Pharmaceutical Product (CPP) from Country of Origin (For Importers)

✓ Receipt of Official Treasury Fees Deposited on CDSCO SUGAM Portal (`cdscomdonline.gov.in`)

Registration Workflow

Step-by-Step Medical Device Registration Process in Rajasthan

How Shree Meeracorp manages your Medical Device Licensing with CDSCO & SLA:

Device Classification Audit

Identify risk classification (Class A, B, C, D) and applicable Indian Standard / Essential Principles checklist.

Test License & NABL Testing

Apply for Test License (Form MD-12/13) to manufacture test batches and conduct NABL laboratory testing.

DMF & PMF Compilation

Compile Device Master File, Plant Master File, ISO 13485 QMS manual, and packaging artworks.

SUGAM Portal Filing

Submit Form MD-3 (Class A/B) or Form MD-7 (Class C/D) online on `cdscomdonline.gov.in` and pay govt fees.

Audit & License Grant

Coordinate Drug Inspector / Notified Body factory audit and obtain MD-5 / MD-9 / MD-15 Manufacturing/Import License.

Professional Assistance

Why Choose Shree Meeracorp?

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CDSCO & MDR 2017 Regulatory Expertise

In-depth expertise in Medical Devices Rules 2017, risk classification rules, and CDSCO SUGAM portal workflows.

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DMF & PMF Dossier Drafting

Flawless drafting of Device Master Files (DMF), Plant Master Files (PMF), and Risk Analysis reports as per GHTF norms.

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ISO 13485 QMS Implementation

Guiding medical device manufacturing teams on cleanroom design, ISO 13485 QMS implementation, and calibration.

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NABL Lab Testing Coordination

Assisting manufacturers in drawing test samples and clearing testing at CDSCO-approved NABL laboratories.

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Drugs Control Dept & CDSCO Liaison

Active coordination with Rajasthan State Licensing Authority (Drug Controller, Jaipur) and CDSCO CLA offices.

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Dedicated Consultant

Personalized attention, file tracking, and milestone updates from initial risk audit to final MD License delivery.

FAQ

Frequently Asked Questions

Medical Devices in Rajasthan are regulated under the Medical Devices Rules (MDR), 2017 by the Central Drugs Standard Control Organization (CDSCO, Ministry of Health) and the Rajasthan State Licensing Authority (Drugs Control Organization).

For Class A (Low Risk) and Class B (Low-Moderate Risk) devices, manufacturers apply via Form MD-3 to the Rajasthan State Licensing Authority to obtain the Form MD-5 Manufacturing License.

For Class C (Moderate-High Risk) and Class D (High Risk) devices, manufacturers apply via Form MD-7 to CDSCO Central Licensing Authority (CLA) to obtain the Form MD-9 Manufacturing License.

Importers apply for an Import License via Form MD-14 on the CDSCO SUGAM portal to obtain a Form MD-15 Import License through an authorized Indian agent.

For Class A & B devices, license processing takes 30 to 60 working days. For Class C & D devices and Import licenses, processing typically takes 60 to 90 working days.

Get Your Medical Device License in Rajasthan Today!

Speak with Shree Meeracorp for device classification, DMF/PMF dossier drafting, ISO 13485 QMS audit, and CDSCO SUGAM portal registration in Rajasthan.

Call Now: +91 88008 96808

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