Drug & Medical Devices · Gurgaon · HR

Medical Device Manufacturing Licence (Class A/B) in Gurgaon

Manufacture low and low-moderate risk medical devices legally. We confirm the risk class, prepare the Device Master File and Plant Master File, file Form MD-3 on the Medical Devices Online portal, coordinate the notified body audit and handle queries until your MD-5 licence is granted.

Risk class confirmedDevice & Plant Master Files preparedNotified body audit coordinated
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Reviewed & verified Reviewed by TaxClue Compliance Team Updated 23 September 2026 Drugs and Cosmetics Act 1940 & Medical Devices Rules 2017 CA · CS managed filing Fixed fee quoted upfront
At a glance
CA / CSQualified Team EXPERTSProfessionally Managed ONLINEEnd-to-End Process FIXEDFee Quoted Upfront EVERY 5 YEARSPay the licence retention fee · Review the Plant Master File and QMS · Refresh standards compliance for each device ONGOINGMaintain the QMS and batch records · Submit post-market surveillance data as required · Keep labels and IFU compliant EVENT-BASEDApply for endorsement before adding new devices · Inform the authority of a change of constitution within 45 days and apply afresh within 180 days · Notify major label changes ON REQUESTObtain Market Standing and export certificates for tenders · Face inspections and audits · Respond to complaints and field actions GOVERNING LAWMedical Devices Rules, 2017 APPLICATIONForm MD-3 LICENCEForm MD-5 AUTHORITYState Licensing Authority AUDITCDSCO-registered notified body PORTALMedical Devices Online / NSWS
Local jurisdiction

Medical Device Manufacturing Licence (Class A/B) in Gurgaon

Registrar (RoC)

RoC Delhi (for Haryana) — 4th Floor, IFCI Tower, 61 Nehru Place, New Delhi – 110019 · roc.delhi@mca.gov.in

Jurisdictional HC

Punjab & Haryana High Court

GSTIN prefix

06 (Haryana) · state tax portal

Professional Tax

Haryana does not levy professional tax, so there is no PT registration or return for employers here.

Shops & Establishments

Punjab Shops and Commercial Establishments Act, 1958 (as applicable to Haryana)

Labour Welfare Fund

Applicable — contributed monthly.

Business hubs

DLF Cyber City, Golf Course Road, Sector 44, Sohna Road, MG Road

Gurgaon (Gurugram) is India's corporate city — home to Fortune 500 offices, fintech startups, and some of India's largest unicorns. Excellent infrastructure and proximity to Delhi airport make it a top business destination.

Also in: Delhi Noida
At a glance

Medical Device Manufacturing Licence (Class A/B) in brief

Who it applies to, what it costs, how long it takes and which law governs it — before the details.

MD-5Class A / B licenceGranted by the State Licensing Authority and valid in perpetuity, subject to a licence retention fee every five years.
Talk to a Medical Device Licensing Expert

Under the Medical Devices Rules, 2017 (MDR), a licence is needed to manufacture medical devices for sale or distribution in India. For Class A (low risk) and Class B (low-moderate risk) devices, the licensing authority is the State Licensing Authority: the application is made in Form MD-3 and the licence is granted in Form MD-5, with the manufacturing site audited by a CDSCO-registered notified body. Class A devices that are non-sterile and non-measuring are exempt from licensing but must be registered on the Medical Devices Online portal. Class C and D devices are licensed centrally by CDSCO (Form MD-7 / MD-9). Licences remain valid in perpetuity, subject to a retention fee every five years.

Professional Fee
Custom quote
Governing Law
Medical Devices Rules, 2017
Application
Form MD-3
Licence
Form MD-5
Authority
State Licensing Authority
Audit
CDSCO-registered notified body
Portal
Medical Devices Online / NSWS
Validity
Perpetual + retention fee
Legal & regulatory framework
Act
Drugs and Cosmetics Act, 1940
Rules
Medical Devices Rules, 2017
Forms
MD-3 → MD-5 (Class A/B)
Authority
State Licensing Authority
Portal
Medical Devices Online / NSWS
Last Reviewed
23 Sep 2026
Chapter 01Understand it
Understand It

What Is Medical Device Manufacturing Licence (Class A/B)?

A quick, plain-language explanation before the details.

In simple terms

A medical device manufacturing licence is the government permission a factory needs to make medical devices for sale in India. For Class A and B devices, it is granted by the state drug regulator after checking your quality system and facility.

Legally

All medical devices are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 (following S.O. 648(E) and G.S.R. 102(E) dated 11 February 2020). Class A and B manufacturing licences are applied for in Form MD-3 and granted in Form MD-5; the quality management system follows the Fifth Schedule.

Governing authority

The State Licensing Authority licenses manufacture of Class A and Class B devices. The Drugs Controller General (India) at CDSCO, as Central Licensing Authority, licenses Class C and D manufacture, all imports, notified bodies and test licences.

Validity

Manufacturing licences under MDR 2017 remain valid in perpetuity unless suspended or cancelled, provided the licence retention fee is paid every five years.

Before You Start

Is This Service Right for You?

Ideal for

  • Manufacturers of Class A and Class B devices setting up a new plant
  • Contract manufacturers producing devices for brand owners
  • MSMEs making consumables, dressings, supports and instruments
  • Makers of sterile Class A or measuring devices needing a licence
  • Startups moving from test batches to commercial manufacture
  • Existing licence holders adding products or changing constitution

You may need this if

  • You manufacture a product that falls within the definition of a medical device
  • Your device is Class A (sterile or measuring) or Class B
  • You are starting commercial manufacture after test or evaluation
  • You want to add new devices to an existing manufacturing licence
  • Your company’s constitution has changed and the licence must be updated
  • You make Class A non-sterile, non-measuring devices and need the portal registration

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Why it matters

Why Is a Medical Device Manufacturing Licence Essential?

Since all medical devices came under the licensing regime, manufacturing without the right licence or registration exposes you to action under the Drugs and Cosmetics Act. Here is why it matters.

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  1. Legal Requirement

    Manufacture of Class A (other than non-sterile, non-measuring) and Class B devices for sale or distribution needs a licence from the State Licensing Authority.

  2. Quality System Recognition

    The licence confirms your quality management system meets the Fifth Schedule of MDR 2017.

  3. Hospital & Tender Access

    Hospitals, distributors and government tenders ask for a valid manufacturing licence and related certificates.

  4. Export Certificates

    The licensing authority that issued your licence can issue export and tender certificates such as Market Standing and Non-Conviction certificates.

  5. Perpetual Validity

    Once granted, the licence continues as long as the retention fee is paid every five years.

  6. Room to Expand

    New devices can be added to an existing licence through an endorsement application.

Chapter 02Get it done
Transparent

Simple, Transparent Pricing

Custom quote for your case

Fees depend on your business type and scope. Get a clear, itemised quote upfront — no hidden professional charges, government fee billed at actuals.

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Eligibility

Who Can Apply?

Manufacturers with their own facility
Contract / loan-licence manufacturers
MSMEs and startups in medtech
Makers of sterile or measuring Class A devices
Class B device manufacturers
Existing licensees adding devices

Eligibility checklist

  • The product meets the definition of a medical device and its risk class is confirmed
  • A manufacturing site meeting the Fifth Schedule QMS and environmental norms
  • Competent technical staff as required by the rules
  • Device Master File and Plant Master File for the site and devices
  • Compliance with applicable BIS or other standards for the device
  • Registration on the Medical Devices Online portal / NSWS
End-to-End

Everything You Need. One Professional Team.

8 steps, every one handled by our teamTalk to a Medical Device Licensing Expert →
01

Risk Classification

Confirm the device’s risk class and whether it is licensable or registration-only.

02

Regulatory Pathway

Map the route — Class A registration, Class A/B licence with the state, or Class C/D with CDSCO.

03

Device Master File

Prepare the Device Master File with design, materials, standards, labelling and testing.

04

Plant Master File

Prepare the Plant Master File for the site as prescribed in the Fourth Schedule.

05

QMS Readiness

Gap-check your quality management system against the Fifth Schedule before the audit.

06

MD-3 Filing

File Form MD-3 on the Medical Devices Online portal with the fee payable to the State Licensing Authority.

07

Audit & Queries

Coordinate the notified body audit and respond to queries from the licensing authority.

08

Post-Licence Support

Handle endorsements, retention fees, labelling reviews and post-market obligations.

No Ambiguity

What You’ll Receive

Manufacturing licence in Form MD-5
Risk classification & pathway note
Device Master File
Plant Master File
QMS gap assessment against the Fifth Schedule
MD-3 application on the online portal
Notified body audit coordination
Retention fee & endorsement calendar
Checklist

What Documents Are Required for a Class A / B Manufacturing Licence?

Documents are submitted as per the checklist on the Medical Devices Online portal. The Device Master File and Plant Master File carry most of the weight. Keep clear scans (PDF) ready — we collect everything securely over email.

Choose a document group

Company & Site

Entity & premises proof
4 documents
  • Constitution documents and PAN of the manufacturer
  • Ownership or lease documents for the manufacturing site
  • Site layout and plant details
  • Details of technical staff and their qualifications

Class A non-sterile, non-measuring

These devices are exempt from licensing but must be registered on the Medical Devices Online portal. A system-generated registration number is issued, and per CDSCO no fee is charged. Labelling rules still apply.

Fees under the Second Schedule

Licence fees are prescribed in the Second Schedule of MDR 2017 and paid to the State Licensing Authority, at actuals. A separate fee applies for each brand, and fees are not refundable.

Notified body audit

Only notified bodies registered with CDSCO can audit Class A and B manufacturing facilities. We coordinate the audit and help close non-conformities.

BIS standard first

Where a BIS standard exists for your device, compliance with it is mandatory; otherwise ISO / IEC or other recognised standards apply.

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Step by Step

How to Get a Class A / B Manufacturing Licence (Step by Step)

The application is filed online on the Medical Devices Online portal to the State Licensing Authority.

6 steps from start to finishTalk to a Medical Device Licensing Expert →
01

Classification & pathway

We confirm the device definition, risk class and whether a licence or only portal registration is needed.

02

Master Files & QMS

Prepare the Device Master File and Plant Master File and close QMS gaps against the Fifth Schedule.

03

MD-3 on the portal

File Form MD-3 on the Medical Devices Online portal with documents and the fee to the State Licensing Authority.

04

Scrutiny & audit

The licensing authority scrutinises the application and a CDSCO-registered notified body audits the facility.

05

Queries & non-conformities

We respond to queries and help close any audit non-conformities.

06

MD-5 licence granted

On satisfaction, the State Licensing Authority grants the manufacturing licence in Form MD-5.

How Long It Takes

How Long Does a Class A / B Manufacturing Licence Take?

StageExpected Time
Classification, Master Files & QMS readinessDepends on facility and documentation readiness
MD-3 filing, scrutiny & notified body auditAs per MDR 2017 timelines
Query / non-conformity closure & MD-5 grantSubject to State Licensing Authority processing

MDR 2017 prescribes timelines for scrutiny, audit and decision. Draft amendments published in 2026 propose shorter timelines, including a thirty-day scrutiny window for Class B applications, but these are not yet final. Readiness of the Master Files and QMS is the biggest factor.

Compliance Calendar

Key Dates — At a Glance

FrequencyWhat Is Due
Every 5 YearsPay the licence retention fee · Review the Plant Master File and QMS · Refresh standards compliance for each device
OngoingMaintain the QMS and batch records · Submit post-market surveillance data as required · Keep labels and IFU compliant
Event-BasedApply for endorsement before adding new devices · Inform the authority of a change of constitution within 45 days and apply afresh within 180 days · Notify major label changes
On RequestObtain Market Standing and export certificates for tenders · Face inspections and audits · Respond to complaints and field actions

Dates are indicative and may change with government notifications. Our team tracks every deadline so you never miss a filing.

Chapter 03After you register
Why Outsource

Doing It Yourself vs TaxClue

Doing It Yourself

  • Classify the device and pick the pathway yourself
  • Write the Device and Plant Master Files from scratch
  • Gap-check QMS without a Fifth Schedule checklist
  • Learn the Medical Devices Online portal
  • Arrange and face the notified body audit alone
  • Answer licensing authority queries unaided
  • Risk rejection with a non-refundable fee

With TaxClue

  • Risk class and pathway confirmed first
  • Device and Plant Master Files prepared
  • QMS gaps closed before the audit
  • MD-3 filed on the portal for you
  • Notified body audit coordinated
  • Queries answered by our team
  • Retention fee and endorsements tracked

Skip the guesswork.

Let an expert handle it →
After you register

What happens next

Avoid Delays

Common Mistakes That Delay Your Application

Wrong risk class leading to the wrong licensing authority
Treating a sterile or measuring Class A device as exempt
Weak Device Master File or Plant Master File
QMS not aligned with the Fifth Schedule before the audit
Ignoring an applicable BIS standard
Labels and IFU not meeting Chapter VI
Not reporting a change of constitution in time
Missing the five-yearly licence retention fee

TaxClue reviews your documents before filing to reduce avoidable errors.

Chapter 04Why TaxClue
The Difference

Why Businesses Choose TaxClue

01

Regulatory Team

Professionals familiar with MDR 2017, the Medical Devices Online portal and state regulators.

02

Dossier Discipline

Device and Plant Master Files built to the Fourth Schedule format.

03

Always Updated

We track MDR amendments, drafts and CDSCO notices.

04

Fully Online

Most work over email and calls, with coordination for audits on site.

05

Transparent Fees

A clear quote upfront — government fees at actuals, zero hidden charges.

06

Post-Licence Support

Endorsements, retention fees, certificates and post-market obligations.

Data Care

Your Documents Deserve Professional Care

  • Design and manufacturing data handled under confidentiality
  • Access limited to the team working on your file
  • Communication over secure digital channels
  • Documents retained only as long as needed for compliance
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Chapter 05Answers & resources
Answers

Frequently Asked Questions

Who grants a licence to manufacture Class A and Class B medical devices?
The State Licensing Authority of the state where the manufacturing site is located. Class C and Class D manufacture, all imports and test licences are handled by the Central Licensing Authority — the Drugs Controller General (India) at CDSCO.
Which forms apply to a Class A / B manufacturing licence?
The application is made in Form MD-3 and the licence to manufacture for sale or distribution is granted in Form MD-5. For Class C and D, the application is in Form MD-7 and the licence in Form MD-9, issued by CDSCO.
Do Class A non-sterile, non-measuring devices need a licence?
No. Per CDSCO, Class A devices that are non-sterile and non-measuring are exempt from the licensing chapters of MDR 2017, but must be registered on the Medical Devices Online portal and comply with labelling requirements. A system-generated registration number is issued, and no fee is charged.
What makes a device a measuring device?
A device intended by the manufacturer to measure quantitatively a physiological or anatomical parameter, or a quantity or characteristic of energy or substances delivered to or removed from the body, with the result displayed in legal or other acceptable units.
Who audits the manufacturing facility for Class A and B?
Only notified bodies registered with CDSCO can audit Class A and Class B manufacturing facilities. The list of registered notified bodies is published on the CDSCO website.
How long is a manufacturing licence valid?
Licences under MDR 2017 remain valid in perpetuity until suspended or cancelled, provided the licence retention fee is paid every five years.
What is the government fee?
The fee is prescribed in the Second Schedule of MDR 2017 and is paid to the State Licensing Authority by challan or electronically as the state specifies. A separate fee applies for each brand, and MDR 2017 has no provision for refund.
Where is the application filed?
Applications under MDR 2017 are filed online on the Medical Devices Online portal (cdscomdonline.gov.in) or through the National Single Window System.
What is a Device Master File and Plant Master File?
The Device Master File describes the device — design, materials, standards, manufacturing, labelling and testing. The Plant Master File describes the manufacturing site; its contents are prescribed in Appendix I of the Fourth Schedule of MDR 2017.
Is GMP certification required for medical devices?
MDR 2017 requires compliance with the Quality Management System in the Fifth Schedule rather than drug GMP. WHO-GMP certificates are generally issued for drug formulations, not devices.
Do I need to follow BIS standards?
Yes, where a BIS standard exists for the device, compliance with it is mandatory. Where there is none, ISO / IEC standards apply, and failing those, pharmacopoeial or validated manufacturer standards.
Can I make test batches before getting the licence?
Yes. A test licence in Form MD-13 can be obtained for manufacturing small quantities for clinical investigation, test, evaluation, demonstration or training. It is valid for three years and is issued by CDSCO.
How do I add a new device to my licence?
Apply for an endorsement with the requisite fee and documents as per the Fourth Schedule and the portal checklist. The endorsement is valid as long as the base licence.
What if our company’s constitution changes?
You must inform the licensing authority within 45 days of the change and apply under MDR 2017 within 180 days. A change of constitution includes, for example, conversion from private to public company or a change of more than half of the voting capital.
Are there changes to the Medical Devices Rules in 2026?
Draft amendments were published in 2026, including G.S.R. 270(E) in April and G.S.R. 515(E) in June proposing shorter scrutiny and audit timelines, including a thirty-day scrutiny window for Class B. These were drafts for consultation; we apply the rules as in force on the date of filing.
Verify Everything

Official Sources & Legal References

Every regulatory detail on this page is drawn from primary law and official government sources. Verify them directly:

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