INTRODUCTION

India is fast emerging as one of the biggest markets for medical devices globally. With the rise in healthcare awareness, hospital infrastructure, diagnostics and personalized care, the demand for medical devices has surged—ranging from simple thermometers to complex life-supporting systems like ventilators, CT scanners and implants.

But with this growth also comes the need for regulation. Medical Device Registration in India is not just about bureaucracy—it's about ensuring patient safety, product traceability and quality control. And yes, it’s now mandatory for almost all classes of medical devices under Indian law.

If you are a manufacturer, importer or distributor of medical devices in India, this blog will walk you through everything—why registration is necessary, who regulates it, eligibility, step-by-step process and how Lawfinity can simplify the journey for you.

WHY IS MEDICAL DEVICE REGISTRATION REQUIRED?

The healthcare ecosystem depends heavily on devices. A malfunctioning glucose monitors or a substandard heart stent doesn’t just mean inconvenience—it can cost lives. That’s exactly why the Government of India brought most medical devices under regulatory control.

Here’s why registration is mandatory now:

Patient Safety: Ensures only safe and validated devices are used in hospitals, clinics and labs.
Traceability: Helps trace and recall defective batches in emergencies.
Compliance with Global Standards: Brings India closer to global frameworks like the US FDA and EU MDR.
Legal Accountability: If a device fails or causes harm, the manufacturer/importer is legally accountable.

Earlier, only 37 notified devices required licensing. But as per the Medical Devices Rules (MDR), 2017, amended over time, now almost all medical devices are regulated—phased gradually in 2021, 2022 and 2023.

In short—you cannot manufacture, import or sell most medical devices without registration anymore.

WHO ISSUES THE MEDICAL DEVICE LICENCE IN INDIA?

The central regulatory authority for all medical device-related approvals is the:

Central Drugs Standard Control Organization (CDSCO)

Under the Ministry of Health and Family Welfare, CDSCO is the apex body that governs:

Licensing and approvals of medical devices
Quality and regulatory inspections
Post-market surveillance
Import and export permissions

Licences are issued by either:

The Drugs Controller General of India (DCGI) – For Class C and D (high-risk) devices
State Licensing Authorities (SLAs) – For Class A and B (low and moderate-risk) devices

All activities—right from registration to license issuance—are done through the official SUGAM portal of CDSCO.

ELIGIBILITY & DOCUMENTS REQUIRED FOR MEDICAL DEVICE REGISTRATION

Whether you are a manufacturer, importer, authorized agent or distributor, you must first understand your eligibility and documentation requirements based on device class.

Device Classification (as per CDSCO)

Class A – Low Risk (e.g., thermometers, surgical dressing)
Class B – Low to Moderate Risk (e.g., syringes, suction equipment)
Class C – Moderate to High Risk (e.g., infusion pumps, CT scanners)
Class D – High Risk (e.g., pacemakers, heart valves)

Who Can Apply?

Indian Manufacturers
Foreign Manufacturers via an Authorized Indian Agent
Importers
Distributors (in some cases under MDR guidelines)

Common Documents Required

1. Covering Letter with details of applicant and purpose

2. Device Master File (DMF) – Technical details, design, usage, testing protocols

3. Plant Master File (PMF) – Manufacturing facility layout, GMP compliance

4. Free Sale Certificate (for imports)

5. CE/FDA Certificate (if available)

6. ISO 13485 Certificate

7. Clinical Evaluation Report (CER)

8. Test Reports (in-vitro diagnostics)

9. Label & Packaging Details

10. Affidavit, undertaking and Authorisation Letters (where applicable)

Note: For Class A (non-sterile, non-measuring), the registration process is via self-certification, while Class B, C and D require a full application and inspection process.

STEP-BY-STEP PROCESS FOR MEDICAL DEVICE REGISTRATION

Medical Device Registration in India is carried out through the SUGAM online portal of CDSCO. Here’s the detailed process, updated with the latest rules.

Step 1: Determine Device Classification

Before anything, you must identify the risk class (A, B, C, D) of your device. CDSCO provides guidance documents to help applicants categorize correctly.

Step 2: Create SUGAM Account

Register as a manufacturer/importer on CDSCO's SUGAM portal (https://cdsco.gov.in). You will need company details, contact person, email verification and digital signature setup.

Step 3: Prepare Technical Documentation

Compile your Device Master File (DMF) and Plant Master File (PMF) along with quality certificates, safety reports, labels, brochures, etc.

Step 4: Submit Application Online

Choose the right form:

Form MD-3 for Class A or B manufacturing licence
Form MD-7 for Class C or D manufacturing
Form MD-14 for import licences
Form MD-42 for registration of distributors/sellers

Upload documents, pay the government fee and submit online.

Step 5: Inspection (If Required)

For Class B, C and D devices, CDSCO or SLA may conduct a site inspection of your manufacturing facility or warehouse. Ensure GMP readiness.

Step 6: Query Resolution

If CDSCO raises any queries, respond via portal within the timeline. Delays can cause rejection or fresh application.

Step 7: Licence Issuance

Upon approval, CDSCO issues the Medical Device Registration certificate valid for five years, subject to renewal and compliance.

GOVERNMENT FEE FOR MEDICAL DEVICE REGISTRATION

The fee structure for Medical Device Registration in India varies based on:

Type of applicant (Manufacturer, Importer, Authorized Agent)
Risk classification of the device (Class A, B, C or D)
Type of application form (Manufacturing, Import, Wholesale, etc.)

Here’s an approximate fee chart as per the latest CDSCO guidelines (2023–2024):

Note: These are government fees only and do not include consultant, technical or testing charges. Also, CDSCO may revise these fees from time to time, so always confirm with the latest circular.

Additional Costs to Consider:

Clinical testing or lab evaluation (if required)
ISO 13485 audit and certification
Training institute MoU (if applicable)
Legal drafting, affidavits and documentation assistance

If you’re not sure which form applies to your case or what classification your device falls under, Lawfinity can help you calculate exact fees and handle end-to-end filing.

PENALTY FOR OPERATING WITHOUT A MEDICAL DEVICE REGISTRATION

Operating without a valid Medical Device Registration in India is a serious offence under the Drugs and Cosmetics Act and Medical Devices Rules, 2017.

Here’s what can happen:

Seizure of goods and facility
Hefty fines up to ₹5,00,000 or more
Imprisonment for up to 2–5 years
Blacklist of your firm for future approvals
Product recall and damage to brand reputation

Even distribution or import without proper registration is punishable. With CDSCO ramping up digital surveillance, compliance is not optional anymore—it’s critical.

HOW LAWFINITY SIMPLIFIES THE REGISTRATION PROCESS

Medical Device Registration may look like a simple online form, but in reality—it’s filled with confusing guidelines, technical language and shifting timelines.

At Lawfinity, we have helped 100+ clients across India get their devices approved—whether they’re manufacturers, startups or foreign companies.

Here’s how we make it easier:

Classification & Strategy: We start by helping you correctly classify your product, identify licensing routes and advise on whether fast-track routes like voluntary compliance can be used.
Documentation Support: Our team prepares your Device Master File, Plant Master File and Quality Certificates—all in the format CDSCO expects, saving you weeks of trial and error.
Portal Filing & Compliance: From creating a SUGAM account to responding to CDSCO queries—we handle everything under one roof, so you don’t miss a step or deadline.
Inspection-Readiness: If inspection is required, we train your team and audit your facility beforehand to ensure you pass without hiccups.
End-to-End Advisory: Whether it’s a new licence, modification, renewal or expansion into other states—we provide ongoing support even after the licence is issued.

You focus on your technology and innovation. Let Lawfinity handle the law and documentation.

MUSING FROM THE AUTHOR’S INK

In the world of medicine, where lives hinge on precision, trust and technology, a single device can spell the difference between hope and harm. And yet, amidst this life-saving potential lies a quiet complexity—regulatory compliance. For many entrepreneurs, manufacturers and startups in the medical device space, the CDSCO regulations seem like just another bureaucratic obstacle. But if you pause and look closely, you will realise—it’s not about ticking boxes, it’s about building accountability.

Having worked closely with businesses across industries, we at Lawfinity have seen how clarity in compliance can become a powerful enabler. It empowers you to grow confidently, secure partnerships and build a product that doesn’t just sell—but saves lives ethically and lawfully.

This guide wasn’t just written to inform—it was written to empower. If even one innovator, one manufacturer or one small distributor decides to formalize their device through the right legal route after reading this, we have done our bit for public health and the rule of law.

Because compliance isn’t paperwork—it’s protection.

For your business. For your users. For your conscience.