Used by 450+ corporate clients across India since 2015

Medical Device Registration in India and CDSCO Licences

Medical device registration in India means holding the licence or registration the Medical Devices Rules, 2017 require before a device is made or imported for sale. LexComply classifies your device as Class A, B, C or D, helps prepare the dossier and file the application on the CDSCO online portal, and tracks retention fees on a platform used by 450+ corporate clients.

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A regulatory affairs professional in an Indian medical device quality lab checking a sterile device pouch against its technical document, representing LexComply's medical device registration services in India

Our Medical Device Registration Services

One route for each licence the Medical Devices Rules, 2017 set out, from classification to the licence in hand.

Medical Device Import License

Import licence on Form MD-15, applied for on Form MD-14 with the Central Licensing Authority, for devices made overseas, other than Class A non-sterile, non-measuring devices, which are registered instead. LexComply helps build the dossier and tracks CDSCO queries.

Check Applicability

Indian Authorised Agent Support

A foreign manufacturer applies through an authorised agent in India appointed by power of attorney. LexComply helps you check a proposed agent's eligibility under Rule 34, draft the power of attorney and prepare the MD-14 filing.

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Class A and B Manufacturing Licence

Manufacturing licence on Form MD-5, applied for on Form MD-3 with the State Licensing Authority, for Class B and for sterile or measuring Class A devices. LexComply helps with the file and with preparing for the notified body audit.

See the MD-5 Licence

Class C and D Manufacturing Licence

Manufacturing licence on Form MD-9, applied for on Form MD-7 with the Central Licensing Authority, for moderate-high and high risk devices. LexComply helps you prepare the dossier and get ready for the CDSCO inspection before grant.

Plan My Application

Medical Device Classification

A written view of where each device falls among the 4 risk classes under the First Schedule, including whether a non-sterile, non-measuring Class A device needs only online registration, so the form and authority are settled first.

See CDSCO Approvals

Licence Retention and Tracking

Licences under the 2017 Rules stay valid in perpetuity unless suspended, cancelled or surrendered, provided the retention fee is paid every 5 years. LexComply tracks each retention date and amendment in its compliance platform with every other Act you follow.

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A compliance specialist in India working through a medical device technical file beside a boxed blood pressure monitor, the dossier preparation step of medical device registration

How a Medical Device License Is Obtained With LexComply

Device Classification

We classify each device you plan to make or import in India by intended use and risk, Class A, B, C or D, and name the licensing authority, central or State, and the form that applies. The output is a written note you can share with your team.

Authorised Agent and Site Mapping

For imports we confirm that your Indian authorised agent holds an eligible licence and help draft the power of attorney. For manufacturing we map every site and device family to the correct application, so no plant or product line is left outside the licence you receive.

Dossier Preparation

We help you assemble the device and plant master files, the quality management and free sale certificates your device class requires, and the labels and instructions for use, then check each document against CDSCO's requirements before anything is submitted to the authority.

Online Filing and Queries

We help you file on CDSCO's Online System for Medical Devices with the fee set in the Second Schedule, track and answer each query, and prepare for any inspection or audit until the licence is granted, recording every submission in a complete, auditable trail.

Retention and Assurance

Your licence then sits in LexComply's compliance platform beside every other obligation your entities carry across India. Retention fee dates, amendments for new devices and site changes are tracked, and a new or extended due date reaches the accountable owner within 48 hours.

Start My Device Application

For foreign manufacturers

Indian Authorised Agent for Foreign Device Makers

A manufacturer based outside India does not file the import licence application itself. The Form MD-14 application is made by an authorised agent in India, appointed under a power of attorney, that holds a manufacturing licence, a wholesale licence or a registration certificate in Form MD-42. Some manufacturers already work with an Indian distributor that qualifies, and for them the job is getting the paperwork right. LexComply helps you assess whether a proposed agent is eligible, draft the power of attorney and prepare the MD-14 dossier, and coordinates the filing so the licence matches the devices you intend to sell.

Discuss My Agent Setup

Cartons of imported medical devices on warehouse racking in India, the stock an import licence under the Medical Devices Rules, 2017 must cover

From LexComply users

What Clients Say About the LexComply Platform

it keeps us updated with all regulatory and statutory changes, updates as soon as they're implemented/rolled out. It's been our saviour and alarm clock !!!

RachnaLawyer★★★★★

Contains every bit of information and the best part is it keeps updated with latest changes in acts rules etc.

Gaurav KapoorLegal Services★★★★★

Useful software for the organisation. Provide good control mechanisms for top management

Automotive IndustryHead Legal & Company Secretary★★★★☆

Licence plus tracking

Why Choose LexComply as Your CDSCO Consultant?

New Delhi Base, Pan-India Filing

Based in New Delhi since RSJ Lexsys was incorporated in 2015, LexComply helps businesses across India prepare and file medical device licence applications with CDSCO and State Licensing Authorities through to a decision.

Licence and Tracking in One Place

Your device licence does not end at grant. Retention fee dates and amendments move into LexComply's compliance platform, which 450+ corporate clients already use to track 10,000+ laws.

Expert-Guided from Classification to Licence

Every application follows the same expert-guided steps, from classifying the device to the licensing decision, and you get the class, the authority and the form in writing before anything is filed.

About LexComply

A RegTech company built by legal and finance practitioners

LexComply is the anchor brand of RSJ Lexsys Private Limited, a RegTech company incorporated in New Delhi in 2015. Its registration services cover Central and State licences across India, from CDSCO approvals and legal metrology to EPR and factory licences, and its leadership brings more than 80 years of combined experience across law, chartered accountancy, company secretarial practice and enterprise technology. LexComply's compliance platform and services are used by manufacturing, automotive, consumer goods, healthcare, real estate and logistics enterprises, including two of the Big 4 global accounting and tax firms. Today 450+ corporate clients and 20,000+ active users run their obligations on the platform. Once a device licence is granted, its retention dates and amendments move into the same compliance register that tracks 10,000+ laws.

450+Corporate Clients
20,000+Active Users
80 yearsCombined Leadership Experience

Medical Device Registration in India FAQs

What is medical device registration in India?

It is the licence or registration a manufacturer or importer must hold under the Medical Devices Rules, 2017 before a device is made or imported for sale. The State Licensing Authority licenses Class B manufacturing and sterile or measuring Class A manufacturing; the Central Licensing Authority at CDSCO licenses Class C and D manufacturing and imports.

How are medical devices classified in India?

Devices are classified by risk into four classes: Class A (low), Class B (low moderate), Class C (moderate high) and Class D (high), with the same four classes for in vitro diagnostic devices. The class decides which licensing authority you apply to, which form you use and the fee you pay, so it is settled first.

Which forms are used for medical device registration in India?

An importer applies on Form MD-14 for an import licence on Form MD-15. A Class A or B manufacturer applies on Form MD-3 for a licence on Form MD-5, and a Class C or D manufacturer on Form MD-7 for a licence on Form MD-9. Class A non-sterile, non-measuring devices are registered online instead.

Does a foreign manufacturer need an Indian authorised agent?

Yes. Under Rule 34 the import licence application is made by an authorised agent in India, appointed by the overseas manufacturer through a power of attorney, that holds a manufacturing licence, a wholesale licence or a Form MD-42 registration certificate. LexComply helps foreign manufacturers check a proposed agent's eligibility and prepare the MD-14 application.

What does medical device registration in India cost?

There are two parts. The government fee is set in the Second Schedule to the Medical Devices Rules, 2017 and is charged per site plus per device, in Indian currency for manufacturing and in US dollars for imports. The professional fee depends on the device class, the number of devices and sites, and the state of your dossier. LexComply quotes both before work starts.

How long does medical device registration in India take?

The Rules set outer limits: the Central Licensing Authority decides an import application within nine months, and a Class C or D manufacturing application within 45 days of receiving the inspection report. Missing certificates, an ineligible authorised agent or an incomplete device master file are common causes of delay. LexComply gives you a realistic timeline after classification.

Is medical device registration in India done online?

Yes. Manufacturing and import applications are filed on CDSCO's Online System for Medical Devices, along with the documents and fee. LexComply helps prepare the submission and file it on the portal, and records every acknowledgement and query response so your team holds a complete trail.

How long is a medical device license valid in India?

Import and manufacturing licences under the Medical Devices Rules, 2017 remain valid in perpetuity unless suspended, cancelled or surrendered, provided the licence retention fee is paid every five years. A late fee applies within a short grace window. LexComply tracks each retention date in its compliance platform.

Not sure which class your device falls in

A specialist can confirm your device class, the authority and the form you need before you commit to anything.

Confirm My Device Class

Independent recognition

Awards and Recognition

Compliance Management System of the Year 2023

Awarded at the UBS Forum, Mumbai.

Prithvi Awards, Startup Focused on ESG

Presented by Union Minister Shri Arjun Ram Meghwal.

Entrepreneur Awards 2023

MSME Online Business Entrepreneur of the Year, CS Gaurrav Jaiin.

Talk to a Medical Device Registration Specialist

Tell us which devices you make or import, where they are manufactured and whether you already work with an Indian distributor. A LexComply specialist will confirm the device class, the licence route and what registration involves for you.

info@lexcomply.com

Request a Device Licence Assessment

Connect with one of our platform specialists to discuss how can we help your business stay out in front.

info@lexcomply.com Check My Device Class