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Medical Device Registration in Haryana

CDSCO SUGAM Portal (`cdscomdonline.gov.in`) & FDA Haryana Medical Device Manufacturing, Import & Wholesale Licensing

Are you a medical device manufacturer, IVD diagnostic kit producer, importer, or wholesale distributor in Gurugram, Faridabad, Panipat, Ambala, Rohtak, Karnal, Hisar, Panchkula, Sonipat, or anywhere in Haryana seeking CDSCO Central Licensing Authority (CLA) or State Licensing Authority (FDA Haryana) registration under Medical Devices Rules, 2017 (MDR 2017)? Get 100% compliant regulatory support for CDSCO SUGAM Medical Device Portal (`cdscomdonline.gov.in`) e-filing, Risk-Class A, B, C & D device classification, Form MD-3 / MD-5 Manufacturing License, Form MD-14 Import License, Form MD-42 Wholesale Registration, ISO 13485 Quality Management System (QMS) audit preparation, Device Master File (DMF) & Plant Master File (PMF) drafting, and official license grant with Shree Meeracorp.

What's Included?
✓ Medical Device & In-Vitro Diagnostic (IVD) Risk Classification (Class A, B, C, D)
✓ Form MD-3 & MD-5 Manufacturing License via FDA Haryana / CDSCO SUGAM
✓ Form MD-14 Import License & Authorized Agent (Indian Authorized Rep) Appointment
✓ Form MD-42 Wholesale Registration Certificate for Distributors in Haryana
✓ Device Master File (DMF), Plant Master File (PMF) & ISO 13485 QMS Audit Prep
✓ Drug Inspector Plant Inspection Representation & Regulatory Approval Grant
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Medical Device Registration Haryana

Medical Device Registration in Haryana is a mandatory regulatory licensing framework governed by the Central Drugs Standard Control Organization (CDSCO, Ministry of Health and Family Welfare, Govt. of India) and Food and Drugs Administration (FDA Haryana) under the Medical Devices Rules, 2017 (MDR 2017).

  • Risk-Based Classification: Class A (Low Risk), Class B (Low-Moderate), Class C (Moderate-High), Class D (High Risk)
  • State Licensing Authority (FDA Haryana): Handles Class A & B Manufacturing Licenses (Form MD-5)
  • Central Licensing Authority (CDSCO New Delhi): Handles Class C & D Manufacturing & All Import Licenses (Form MD-15)
  • Form MD-42 Registration Certificate Compulsory for Wholesale Dealers & Retail Stockists
  • Mandatory ISO 13485 QMS Certification, Technical Testing & Environmental Audit Compliance

What is Medical Device Registration in Haryana?

Haryana is a major pharmaceutical, healthcare equipment, and medical technology hub with booming industrial corridors in Gurugram, Faridabad, Ambala, Panipat, and Sonipat. Under the Medical Devices Rules, 2017, all notified medical equipment, surgical instruments, implants, diagnostic kits, and software as a medical device (SaMD) must be registered with CDSCO before being manufactured, imported, or distributed in India.

The registration system operates electronically through the CDSCO SUGAM Medical Device Online Portal (`cdscomdonline.gov.in`). Applicants must submit structured Device Master Files (DMF), Plant Master Files (PMF), Risk Analysis Reports, and Essential Principles Checklists, followed by physical plant inspection by Drug Inspectors or Notified Bodies.

Shree Meeracorp assists medical device manufacturers, importers, and distributors across Gurugram, Faridabad, Ambala, Panchkula, Sonipat, and all Haryana districts with SUGAM portal e-filing, DMF/PMF drafting, ISO 13485 QMS audit preparation, and securing CDSCO & FDA Haryana licenses.

Why Apply?

Benefits of Medical Device Registration in Haryana

Obtaining CDSCO and FDA Haryana Medical Device Approval legalizes manufacturing and distribution, ensures hospital procurement eligibility, and enables pan-India sales.

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100% Legal Work & Supply Authority

Legally authorizes your enterprise to manufacture, import, warehouse, and supply registered medical devices and IVDs across India.

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Customs ICEGATE Clearance Eligibility

Mandatory Form MD-15 Import License allows importers to clear medical device shipments through Customs without port seizure or rejection.

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Government Hospital & AIIMS Tender Onboarding

A valid CDSCO manufacturing/import license is a compulsory pre-qualification requirement for participating in AIIMS, Government Hospital, and GeM procurement tenders.

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High Healthcare Brand Trust

Regulatory compliance with MDR 2017 and ISO 13485 reassures doctors, hospitals, and diagnostic labs regarding product safety and performance.

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Global Export Authorization

Holding CDSCO manufacturing approval enables Indian medical device makers to obtain Free Sale Certificates (FSC) for exporting to international markets.

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Protection from Heavy Fines & Penalties

Shields your business against criminal prosecution, factory sealing, and heavy penalties under the Drugs and Cosmetics Act, 1940.

Checklist

Documents Required for Medical Device Registration in Haryana

Required documentation checklist for uploading on the CDSCO SUGAM online portal (`cdscomdonline.gov.in`):

✓ Aadhaar Card & PAN Card Proof of Authorized Signatory / Directors / Partners
✓ Active GST Registration Certificate with Registered Premises Address in Haryana
✓ Business Entity Proof (Certificate of Incorporation, MOA/AOA, Partnership Deed, or MSME Udyam)
✓ Approved Plant Blueprint, Premises Layout Plan, Cleanroom HVAC Validation & Fire NOC Proof
✓ Device Master File (DMF) detailing Product Design, Risk Analysis, Material Specs, & Shelf Life Data
✓ Plant Master File (PMF) detailing Manufacturing Equipment, Utility Systems, & Production Capacity
✓ ISO 13485 Quality Management System (QMS) Certificate issued by an Accredited Certification Body
✓ Technical Qualification & Appointment Proof of Qualified Technical Staff (Production & Quality Testing Experts)
✓ Complete Product Biocompatibility, Sterilization Validation, & Technical Performance Test Reports
✓ Power of Attorney (PoA) appointing Indian Authorized Agent (For Importers applying for Form MD-14)
✓ Free Sale Certificate (FSC) & CE / USFDA Certificate issued by Foreign Regulatory Authority (For Importers)
✓ Receipt of Official Government Registration Fees Deposited via Bharatkosh Portal
Registration Workflow

Step-by-Step Medical Device Registration Process in Haryana

How Shree Meeracorp manages your CDSCO & FDA Haryana Licensing:

1

Risk Classification & QMS Audit

Classify medical device (Class A, B, C, or D) as per CDSCO notified lists and audit ISO 13485 QMS cleanroom readiness.

2

DMF & PMF Technical Drafting

Draft comprehensive Device Master File (DMF), Plant Master File (PMF), Risk Analysis, and Essential Principles Checklist.

3

SUGAM Portal e-Filing

Submit Form MD-3 / MD-7 or Form MD-14 application on `cdscomdonline.gov.in`, upload files, and pay fees via Bharatkosh.

4

Inspectorate / Notified Body Audit

Coordinate physical plant inspection by Drug Inspectors (FDA Haryana / CDSCO) or accredited Notified Body auditors.

5

Grant of Manufacturing / Import License

Upon technical committee approval, official Manufacturing License (Form MD-5/MD-9) or Import License (Form MD-15) is granted.

Professional Assistance

Why Choose Shree Meeracorp for Haryana Medical Device Licensing?

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CDSCO & MDR 2017 Regulatory Specialization

In-depth expertise in Medical Devices Rules 2017, SUGAM portal e-filing, and CDSCO/FDA Haryana technical guidelines.

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DMF & PMF Technical Dossier Drafting

Expert medical writer preparation for Device Master Files, Plant Master Files, and Risk Management Checklists.

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ISO 13485 QMS & Cleanroom Setup Support

Guiding manufacturing teams in implementing ISO 13485 Quality Management Systems and cleanroom validation protocols.

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FDA Haryana & CDSCO HQ Liaison

Active coordination with FDA Haryana Headquarters (Panchkula) and CDSCO Central Licensing Authority (New Delhi).

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Authorized Agent & Import License Help

Assisting foreign manufacturers and importers with Indian Authorized Agent (IAA) appointment and Form MD-14 filing.

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Dedicated Account Manager

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

FAQ

Frequently Asked Questions

For Class A & B devices, manufacturing licenses (Form MD-5) are issued by the State Licensing Authority (FDA Haryana, Panchkula). For Class C & D devices and all imported items (Form MD-15), licenses are issued by the Central Licensing Authority (CDSCO, New Delhi).
All medical device registration, manufacturing, import, and wholesale applications are processed online through CDSCO’s SUGAM portal (`cdscomdonline.gov.in`).
Yes. Implementing an ISO 13485 Quality Management System (QMS) is a mandatory technical requirement under Medical Devices Rules, 2017 for obtaining manufacturing licenses.
Wholesalers, distributors, and stockists must obtain a Registration Certificate for Sale / Distribution in Form MD-42 from FDA Haryana.
With complete DMF/PMF dossier preparation, SUGAM portal e-filing, and successful plant inspection clearance, license grant typically takes 60 to 90 working days.

Get Your Medical Device Registration in Haryana Today!

Speak with Shree Meeracorp for SUGAM portal e-filing, DMF/PMF dossier preparation, ISO 13485 QMS audit support, and CDSCO / FDA Medical Device Licensing in Haryana.

Call Now: +91 88008 96808
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