Medical Device Registration in Mumbai

CDSCO & FDA Maharashtra Registration under Medical Devices Rules (MDR) 2017 | Form MD-14 Importer & Form MD-3/MD-5 Manufacturing Licenses

Are you a medical device manufacturer, healthcare importer, IVD diagnostic kit distributor, or surgical equipment brand in Mumbai City, Mumbai Suburban, Thane, Navi Mumbai, Kalyan-Dombivli, Mira-Bhayander, Panvel, or across the MMR region requiring mandatory CDSCO Registration? Get 100% compliant, end-to-end Medical Device Registration under the Medical Devices Rules (MDR) 2017 administered by the Central Drugs Standard Control Organization (CDSCO, West Zone Mumbai) and Food and Drug Administration (FDA Maharashtra). Enjoy expert guidance for device risk-based classification (Class A, B, C, & D), Device Master File (DMF) & Plant Master File (PMF) compilation, SUGAM portal / NSWS portal e-filing, Form MD-14 Import License, Form MD-3/MD-5 Manufacturing License, ISO 13485 Quality Management System (QMS) audit preparation, and official Registration Certificate grant with Shree Meeracorp.

What's Included in Registration?

✓ Pre-Application Risk Classification (Class A, B, C, & D) & Regulatory Pathway Audit

✓ Compilation of Device Master File (DMF) & Plant Master File (PMF) per MDR 2017 Standards

✓ Form MD-14 Import License / Form MD-3/MD-5 Manufacturing License Portal Filing

✓ ISO 13485 QMS Certification & Notified Body Technical Audit Readiness

✓ Liaison with CDSCO West Zone (Mumbai Port) & FDA Maharashtra Inspectorates

✓ Grant of CDSCO Registration Certificate / License & Import Clearance Enablement

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CDSCO Approved MDR 2017 Compliance

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SUGAM Portal SUGAM & NSWS e-Filing

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5 Years Perpetual Validity Status

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Medical Device Licensing in Mumbai

Medical Device Registration in Mumbai is the statutory health regulatory compliance governed under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules (MDR), 2017 administered jointly by the Central Drugs Standard Control Organization (CDSCO West Zone, Mumbai) and Food and Drug Administration (FDA Maharashtra).

Risk-Based Classification: Class A (Low), Class B (Low-Moderate), Class C (Moderate-High), Class D (High)
Form MD-14 License Compulsory for Importing Overseas Devices into India
Form MD-3/MD-5 & MD-7/MD-9 Compulsory for Domestic Manufacturing Units
Requires Preparation of Detailed Device Master File (DMF) & Plant Master File (PMF)
Mandatory ISO 13485 QMS Certification & Wholesale Medical Device License (Form 20B/21B)

What is Medical Device Registration in Mumbai?

Mumbai is India’s healthcare and pharmaceutical capital—serving as the gateway for international medical imports through Mumbai Seaport and CSMI Air Cargo Port, while housing major biomedical, surgical, and in-vitro diagnostic (IVD) manufacturing hubs in Thane, Navi Mumbai, Rabale, and Taloja. Under the Medical Devices Rules (MDR) 2017, all medical devices and IVDs sold, manufactured, or imported in India must obtain prior registration or licensing from CDSCO and FDA Maharashtra.

The regulatory framework categorizes devices into four risk classes: Class A (e.g. surgical dressings, wheelchairs), Class B (e.g. hypodermic needles, suction pumps), Class C (e.g. hemodialyzers, lung ventilators), and Class D (e.g. coronary stents, heart valves). Importers require an Indian Authorized Agent (IAA) holding a valid wholesale drug license to secure a Form MD-14 import license, while manufacturers must pass ISO 13485 quality audits and Notified Body inspections.

Shree Meeracorp assists medical device importers, manufacturers, and distributors across Mumbai, Thane, Navi Mumbai, and Panvel with DMF/PMF dossier drafting, ISO 13485 audit readiness, SUGAM portal submission, and obtaining CDSCO Registration Certificates.

Why Register?

Benefits of Medical Device Registration in Mumbai

Obtaining CDSCO Registration legalizes your medical devices, ensures smooth customs clearance at Mumbai ports, and enables sales across Indian hospitals.

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100% Legal Commercialization

Legally authorizes your medical devices and IVD kits to be sold, distributed, and tendered across hospitals and pharmacies in India.

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Seamless Port Customs Clearance

Prevents customs seizure and import detention at Mumbai Seaport and Air Cargo Port by presenting valid Form MD-14 import licenses.

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Hospital & Government Tender Eligibility

Mandatory credential required for participating in central government medical tenders (GeM, Railway Hospitals, ESIC, & Defense).

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International Export Enablement

A CDSCO registered device allows manufacturers in Mumbai to apply for Free Sale Certificates (FSC) to export into global markets.

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Brand Credibility & Clinical Trust

Demonstrates to doctors, surgeons, and healthcare institutions that your product meets stringent safety and quality standards.

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Perpetual License Status

Licenses issued under MDR 2017 remain valid perpetually, subject to payment of retention fees every 5 years.

Checklist

Documents Required for Medical Device Registration in Mumbai

Required documentation checklist for uploading on the official CDSCO SUGAM / NSWS portal:

✓ Wholesale Drug License (Form 20B/21B) of Indian Authorized Agent / Importer in Mumbai

✓ Proof of Business Entity (Certificate of Incorporation, GST Registration, & Premises Proof)

✓ Free Sale Certificate (FSC) / Certificate of Foreign Government issued by Overseas Regulatory Body

✓ ISO 13485 Quality Management System Certificate for Manufacturing Facility

✓ Device Master File (DMF) detailing Product Specs, Material of Construction, & Testing Protocols

✓ Plant Master File (PMF) detailing Manufacturing Site Layout, Cleanroom Class, & Environmental Controls

✓ Power of Attorney (POA) Executed by Foreign Manufacturer in Favor of Indian Authorized Agent

✓ CE Mark / US FDA 510(k) Approval Certificates (If available for fast-track processing)

✓ Biocompatibility Test Reports, Sterilization Validation Reports, & Risk Management Plan

✓ Proposed Product IFU (Instructions for Use), Packaging Labels, & User Manual

✓ Government Online Challan Payment Receipt (Bharatkosh Payment)

Registration Workflow

Step-by-Step Medical Device Licensing Process in Mumbai

How Shree Meeracorp manages your Medical Device Registration on CDSCO SUGAM:

Device Risk Classification

Identify correct risk class (Class A, B, C, or D) and determine regulatory application form (MD-14 / MD-3 / MD-5).

DMF & PMF Compilation

Compile Device Master File, Plant Master File, ISO 13485 audit reports, and power of attorney documents.

SUGAM Portal e-Filing

Submit the application on the CDSCO SUGAM portal (`cdscomdonline.gov.in`) along with Bharatkosh fees.

Technical Scrutiny & Audit

Coordinate technical scrutiny by CDSCO officers (West Zone Mumbai) and Notified Body plant audit (for Class A/B).

Grant of Medical Device License

Upon technical approval, the official Registration Certificate / License (Form MD-15 / MD-5 / MD-9) is granted.

Professional Assistance

Why Choose Shree Meeracorp for Mumbai Medical Device Registration?

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MDR 2017 Technical Specialization

In-depth expertise in Medical Devices Rules 2017, ISO 13485 QMS standards, and CDSCO SUGAM workflows.

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DMF & PMF Technical Drafting

Comprehensive drafting of Device Master Files and Plant Master Files to eliminate technical discrepancy queries.

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Indian Authorized Agent (IAA) Guidance

Assisting overseas manufacturers in establishing Indian Authorized Agent setups and wholesale drug license compliance.

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CDSCO West Zone & FDA Liaison

Active representation and query resolution with CDSCO West Zone HQ (Mumbai Port) and FDA Maharashtra offices.

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Notified Body Audit Preparedness

Guiding domestic manufacturing units through Notified Body audits and ISO 13485 documentation.

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Dedicated Regulatory Consultant

Personalized support and regular tracking until final Registration Certificate download.

FAQ

Frequently Asked Questions

Medical devices in Mumbai are regulated by the Central Drugs Standard Control Organization (CDSCO West Zone, Mumbai) for import/Class C & D licenses, and Food and Drug Administration (FDA Maharashtra) for Class A & B manufacturing licenses.

Devices are classified into: Class A (Low Risk), Class B (Low-Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk).

Form MD-14 is the formal online application form submitted on the SUGAM portal to obtain an Import License (Form MD-15) for importing overseas medical devices or IVDs into India.

An Indian Authorized Agent must be a legally registered Indian business entity holding a valid wholesale drug license (Form 20B/21B) appointed by an overseas manufacturer via a Power of Attorney.

With complete DMF/PMF files, ISO 13485 certificates, and SUGAM portal filing, import licenses (MD-15) typically take 60 to 90 days, while domestic manufacturing licenses take 60 to 120 days.

Get Your Medical Device Registered with CDSCO in Mumbai Today!

Speak with Shree Meeracorp for device classification, DMF/PMF dossier preparation, SUGAM e-filing, and CDSCO Medical Device Registration in Mumbai.

Call Now: +91 88008 96808

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