Used by 450+ corporate clients across India since 2015

Medical Device Manufacturing License in India (MD-5)

A medical device manufacturing license in India is the Form MD-5 licence a State Licensing Authority grants under the Medical Devices Rules, 2017 to make sterile or measuring Class A and B devices. LexComply helps prepare your Form MD-3 and master files and file them on CDSCO's portal, then tracks the licence on a platform used by 450+ corporate clients.

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A technician in a cleanroom gown inspecting a sterile medical device at a manufacturing plant in India, representing LexComply's medical device manufacturing license services

Our Medical Device Manufacturing License Services

One route for a first licence at a new site, and for every device, change or retention date that follows.

MD 5 License for Class B Devices

A Form MD-5 licence from your State Licensing Authority for Class B devices, where a registered Notified Body must audit the site within 90 days of application and report before the licence can be granted.

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Class A Manufacturing License for Medical Devices

A Form MD-5 licence for sterile or measuring Class A devices, which the State Licensing Authority decides within 45 days of application, with the Notified Body audit following within 120 days of grant.

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Loan Licence in Form MD-6

For brand owners who use another licensed plant: a loan licence applied for in Form MD-4 and granted in Form MD-6, which carries the same quality management, technical staff and licence conditions as a licence for your own site.

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Class C and Class D Manufacturing Licence

Higher-risk Class C and D devices follow a separate central route: Form MD-7 to CDSCO, an inspection within 60 days of application and a licence in Form MD-9 granted by the Central Licensing Authority.

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Medical Device Registration and Import Licences

If you also import devices or sell Class A non-sterile, non-measuring products, which since 14 October 2022 are registered online rather than licensed, our CDSCO registration page covers those routes.

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Licence Retention and Change Tracking

After grant, the 5-year retention fee date, major changes needing prior approval, minor changes to intimate within 30 days and new device permissions are all tracked inside LexComply's compliance register.

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A compliance professional in India reviewing a technical file beside medical device samples, the master file step in LexComply's MD-5 licence process

How the MD 5 License Process Works With LexComply

Device Classification
We list every device you plan to make at your site in India and confirm its risk class under the First Schedule, because the class decides everything else: whether you apply to the State or the Central authority, whether an audit comes before grant, and what documents you need.

Site and Staff Readiness
We help you check the plant against the quality management requirements of the Fifth Schedule and confirm your technical staff meet rule 22, which asks for a relevant degree with 2 years of manufacturing or testing experience, or a diploma with 4 years.

Master Files and Form MD-3
We help prepare the plant master file, the device master file for Class B, the essential principles checklist, labels and the quality management undertaking, then file Form MD-3 with the Second Schedule fee on CDSCO's online portal for medical devices.

Notified Body Audit and Queries
For Class B, a registered Notified Body audits the site within 90 days of application and the authority decides within 20 days of its report. For Class A, the audit follows within 120 days after grant. We help you answer each authority query in writing.

Licence Grant and Upkeep
Once the MD-5 licence is granted, it sits in LexComply's compliance platform with your other obligations across India. The 5-year retention fee, change approvals and new device permissions are tracked, so no retention date, change approval or device permission is missed.

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Is outside support worth it

When a Medical Device Manufacturing License Needs a Specialist

A manufacturer with one Class A device, a ready plant master file and experienced technical staff can file Form MD-3 on the portal without help, and some do. A specialist earns its place when you make Class B devices that need a Notified Body audit before grant, run several product lines across one or more sites, or are moving a contract-made product to your own plant. That is the output LexComply produces: each device's class and route checked before filing, the master files reviewed, help with every query, and the licence tracked for retention and changes in one compliance register.

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Gloved hands checking a sealed sterile pouch on a medical device packaging line in an Indian factory

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
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Licence plus tracking

Why Choose LexComply for a Manufacturing License for Medical Devices?

New Delhi Base, Pan-India Filing

Based in New Delhi since RSJ Lexsys was incorporated in 2015, LexComply helps manufacturers across India file with their State Licensing Authority and respond to each query until the MD-5 licence is granted.

Licence and Tracking in One Place

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

Expert-Guided from Classification to Licence

LexComply runs every application through an expert-guided workflow, from the first consultation to the licence in hand, and helps you confirm each device's class and licensing route 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 legal metrology and EPR to factory licences and CDSCO approvals, 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 medical device manufacturing licence is granted, its retention date and every change approval move into the same compliance register that tracks 10,000+ laws.

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

Medical Device Manufacturing License FAQs

What is a medical device manufacturing license in India?
It is the licence a manufacturer needs before making medical devices for sale or distribution under the Medical Devices Rules, 2017. Class B devices and sterile or measuring Class A devices are licensed by the State Licensing Authority in Form MD-5, and Class C and Class D devices by the Central Licensing Authority at CDSCO in Form MD-9.

Who grants a medical device manufacturing license?
It depends on the risk class. Under rule 8, the State Drugs Controller, acting as State Licensing Authority, licenses manufacture of Class B devices and of sterile or measuring Class A devices. The Drugs Controller General of India, as Central Licensing Authority, licenses Class C and Class D manufacture, a separate route with an inspection before grant.

What is an MD 5 license?
Form MD-5 is the licence the State Licensing Authority grants to manufacture Class B or sterile or measuring Class A medical devices for sale or distribution, on an application in Form MD-3. A loan licence for a brand owner using another licensed plant is applied for in Form MD-4 and granted in Form MD-6.

How long does a medical device manufacturing license take?
Under rule 20, applications for sterile or measuring Class A devices are decided within 45 days. For Class B, the Notified Body audits within 90 days of application, reports within 30 days and the authority decides within 20 days of the report. A June 2026 draft amendment proposes revised, mostly shorter, timelines, but it is not yet law.

What documents are needed for a medical device manufacturing license?
The Fourth Schedule's list includes a device description, labels and instructions for use, a plant master file, constitution details, an essential principles checklist and an undertaking of compliance with the Fifth Schedule's quality management system. Class B applications also need a device master file. LexComply helps prepare the set and checks it before filing.

How long is a medical device manufacturing license valid?
A Form MD-5 or MD-6 licence from your State Licensing Authority has no expiry date: under rule 29 it stays in force unless suspended or cancelled, provided a retention fee is paid before five years from issue are completed. Miss it and a late fee of 2% of the retention fee runs for each month or part of a month; after 180 days the licence is deemed cancelled.

Do Class A non-sterile, non-measuring devices need a licence?
No. Since G.S.R. 777(E) of 14 October 2022, Class A devices that are neither sterile nor measuring are exempt from manufacturing licensing. They are registered on the online portal under Chapter IIIB of the Rules instead, with a self-certification that, since August 2026, also covers the quality management system. Sterile or measuring Class A devices still need Form MD-5.

What does a medical device manufacturing license cost?
There are two parts. The government fee is set in the Second Schedule of the Rules and charged in Indian currency per manufacturing site plus per distinct device, and a retention fee is due before five years from the date of issue are completed. The professional fee depends on the number of devices and sites. LexComply quotes both before work starts.

Not sure which class your device falls in

A specialist can classify your devices and confirm which licence and authority apply before you commit to anything.

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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 Licensing Specialist Today

Tell us which devices you plan to make, their risk class if known, where your plant is and whether you already hold a licence. A LexComply specialist will confirm what the MD-5 route involves for you.

info@lexcomply.com

Request a Manufacturing Licence Assessment

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

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