Medical Device Plant Setup in India: Approvals and Licences Roadmap
Before the first machine is installed, a medical device plant needs the right entity, site approvals and a manufacturing licence under the Medical Devices Rules, 2017. We handle applications, documents, portal filings and liaison. Engineers, labs and inspectors handle the technical side.
What it is
Medical device plant setup is not one approval. It is a sequence: form the entity, secure the site, obtain local and environmental clearances, build a quality system, then apply for the manufacturing licence. Getting the order right avoids rework when an inspector asks for papers that should already exist.
Since 2022 and 2023, every notified medical device is licensed under the Medical Devices Rules, 2017 (MDR 2017). Class A and B devices are licensed by the State Licensing Authority of the site, and Class C and D by the Central Licensing Authority at CDSCO. Pharma plants follow the Drugs and Cosmetics Rules, 1945, so a medical device plant setup and a drug plant need different licences. This page covers the approvals roadmap only. For the device-specific licence, see our page on medical device registration.
Who it applies to
Entrepreneurs starting a first plant
Think of a Faridabad engineering workshop that wants to make surgical instruments. It has a shed and a product idea but no licence. We map what to obtain, in what order, before you commit to rent or machinery.
Traders moving into manufacturing
If you import or sell devices today, making them yourself brings a new licence, a quality system and technical staff requirements that trading does not.
Existing manufacturers expanding
A new unit, a new product line or a shift from Class A to Class B or C can trigger fresh applications. We plan these around your production schedule.
Why it matters
Prevents an expensive false start
Pollution, fire and factory approvals can limit where and how you build. Checking them first avoids leasing a site you cannot license.
Aligns paperwork with inspection
The licence application needs a Plant Master File and Device Master File, and an audit or inspection follows. Papers prepared in sequence are easier to defend.
Keeps you legal on day one
Manufacturing without a licence is an offence under the Drugs and Cosmetics Act. Starting only after the licence is in hand protects you and your lenders.
Documents required
Entity and site
- Certificate of incorporation, MOA and AOA
- PAN, GST and Udyam registration
- Ownership or lease deed of the premises
- Site plan and building plan approval
Technical and quality
- Plant Master File and Device Master File
- Quality management system documents
- Qualification and experience proof of technical staff
- List of devices with class and intended use
Regulatory and local
- Factory licence and pollution board consent
- Fire NOC where applicable
- Undertaking under Rule 20(3) with the application
- Fee challan for the correct class
How it works
Register the right entity
Most plants run through a private limited company. We incorporate it, then take PAN, GST and Udyam registrations so the plant has a licensable owner.
Clear the site and local approvals
We prepare applications for the factory licence, pollution board consent to establish and fire safety clearance. Which of them apply depends on the plant.
Build the quality system and master files
Your engineers and quality head draft the quality management system. Many manufacturers pursue ISO 13485 alongside. We assemble the Plant Master File and Device Master File with them.
File the licence application and meet the auditor
We file on the CDSCO medical devices portal, pay the fee, answer queries and coordinate the audit or inspection. Notified bodies, auditors and inspectors do the technical checks.
Licence routes under MDR 2017
| Device class | Authority | Application | Fee |
|---|---|---|---|
| Class A and B | State Licensing Authority | Form MD-3, licence in MD-5 | ₹5,000 per site plus ₹500 per device |
| Class C and D | Central Licensing Authority | Form MD-7, licence in MD-9 | ₹50,000 per site plus ₹1,000 per device |
A test licence under Rule 31 is available to make samples for testing, at ₹500 per device. In Haryana, the State Licensing Authority is the State Drugs Controller. IVD kits follow the same classes under our IVD manufacturing licence page.
If you are building a pharma plant
Drug manufacturing needs a separate licence under Rule 69 of the Drugs and Cosmetics Rules, 1945. The fee is ₹6,000 plus ₹1,500 for inspection for up to ten items in a Schedule M category, with ₹300 for each additional item. Revised Schedule M (GMP) was notified on 28 December 2023. Larger firms had to comply from 28 June 2024, while MSMEs were allowed conditional time to 31 December 2025, so check where your plant stands. Our manufacturing drug licence page covers the process.
Timelines
Class A, B licence
Under Rule 20, the State Licensing Authority decides a Class A application within 45 days. For Class B, the audit follows within 90 days of application and the licence within 20 days of the audit report.
Class C, D licence
Under Rule 21, inspection happens within 60 days. The licence follows within 45 days of the inspection report.
Keeping it alive
Licences are perpetual if you pay the retention fee every five years. Late payment attracts 2 per cent per month, and the licence is cancelled if you stay unpaid beyond 180 days.
What happens if you start without approvals
Prosecution
Section 27(b) of the Drugs and Cosmetics Act provides imprisonment of three to five years and a fine of at least ₹1 lakh or three times the value of the goods, whichever is more.
Stalled licence, idle investment
Papers missing at inspection stall the licence. Your lender may also hold back disbursement until they arrive.
Licence cancellation
An unpaid retention fee beyond 180 days cancels the licence. Diarise the five-year date at the start.
Frequently asked questions
What approvals does a medical device plant need in India?
A plant typically needs a registered entity, premises with building and fire clearance, a factory licence, pollution board consent where applicable and the manufacturing licence under MDR 2017. Class A and B go to the State Licensing Authority, and Class C and D to CDSCO. Which local approvals apply depends on your site and process. We prepare a project-specific checklist before you commit to land or machinery.
Do I need a licence for a Class A device?
Yes. Licensing became mandatory for Class A and B devices from 1 October 2022, and for Class C and D from 1 October 2023. A Class A application is decided within 45 days under Rule 20, and a notified body audits the site within 120 days of the grant. Check the classification first. We confirm yours.
How much does a manufacturing licence cost?
Government fees depend on class. Class A and B cost ₹5,000 per site plus ₹500 per device, and Class C and D cost ₹50,000 per site plus ₹1,000 per device. The same amounts are payable as the retention fee every five years. Land, machinery, labs and consultants are separate. We quote our own fee after reviewing your device list.
Who does the technical work such as layout and testing?
Engineers, plant consultants and accredited laboratories do it, not us. Taxhint handles the application, documents, portal filing, liaison and ongoing compliance. Your technical staff must meet MDR qualifications: a degree in engineering or pharmacy with two years of experience, or a diploma with four years. We plan the paperwork around the people you hire.
Is ISO 13485 mandatory for the licence?
The licence rules require a quality management system under the Fifth Schedule of MDR 2017, and the application carries an undertaking to that effect. ISO 13485 is a separate certification that many manufacturers choose to build the system. Ask us which route suits your device class and your buyers. We coordinate the documents with your auditor.
Can I manufacture before the licence arrives?
Only samples, and only under a test licence. Rule 31 allows a test licence in Form MD-12, granted in MD-13 within 30 days and valid for three years, for ₹500 per device. Commercial manufacture before the main licence is an offence. We help you apply for the test licence early so development is not held back.
Do pharma plants follow the same path?
No. Drug plants apply under Rule 69 of the Drugs and Cosmetics Rules, 1945 and must meet Schedule M. The fee is ₹6,000 plus ₹1,500 inspection for up to ten items per category. Revised Schedule M was notified on 28 December 2023, and MSMEs had until 31 December 2025 on conditions. We check where your unit stands before you build.
Does Taxhint offer subsidies or incentives for plants?
We do not promise any. Central and state incentives change and have conditions, and we only advise on ones we have verified for your location and product. In the meantime we handle the entity, licences and compliance, which any incentive claim will need. Tell us your state and product, and we will check what is currently open.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Ready to begin?
Tell us your device class and state, and we will draw up the approvals roadmap for your plant.