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Project reports in Medical Devices

IV Cannula Manufacturing Project Report

Plant cost, clean room machinery, raw materials, licences and five-year profitability for an IV cannula unit, with a free sample report PDF you can open now.

Plant capacity
44,000 pieces per day
Total project cost
₹512 lakh
Plant and machinery
₹223 lakh
Return on investment
14% (Year 3)
Break-even
49% of capacity
Payback period
About 4.5 years

Figures from our illustrative sample report for a typical unit. They show the format of an NPCS report and are not quotes for your project.

What is a iv cannula project report?

An IV cannula project report is a detailed project report (DPR) for a unit that makes sterile over-needle intravenous catheters from FEP tubing, stainless steel needles and moulded hubs. It sets out the process, clean room machinery, raw materials, licences, project cost, means of finance, five-year projections, DSCR and break-even a bank needs.

Entrepreneurs and existing disposables makers use it to plan the plant and apply for a term loan; lenders use it to judge whether the unit can repay.

Also known as: IV cannula business plan, intravenous cannula manufacturing project report, IV catheter plant DPR, project report on IV cannula.

What a bank checks in an IV cannula project report

A credit officer reads an IV cannula report for a few numbers that show whether thin per-piece margins can still repay the loan. These are the values in our sample report and why each one is tested.

43.7%Raw material share of sales

FEP tubing and needle tubing come from a small number of suppliers. Banks compare this share with your quotations, because a low figure usually means the price of tubing was guessed.

9.1%Packing share of sales

Every cannula is sealed in its own medical paper blister, which is part of the sterile barrier. A report that treats packing as a small extra overstates profit.

60 daysCredit given to buyers

Hospitals, distributors and tender buyers pay late. Receivables are the largest part of working capital in the sample, so they decide the cash credit limit.

1.23Lowest DSCR (Year 2)

The debt service coverage ratio (cash available divided by loan instalments) is weakest when full repayments start after the moratorium. Lenders look at this year, not only the 1.41 average.

Values are the assumptions in our illustrative sample. Your report uses figures for your capacity, suppliers and buyers.

IV cannula manufacturing plant cost in India

Cost depends on how much of the cannula you make in house. An assembly unit buys moulded parts and finished needles; a full unit moulds its own hubs, tips its own catheters and grinds its own needles, as in our sample report.

Assembly unit

₹1.5–3 crore

About 10,000–20,000 pieces per day

  • Assembly, tipping and packing machines₹50–90 lakh
  • Clean room and ETO steriliser₹40–80 lakh
  • Working capital margin₹15–30 lakh

MSME term loan; often in a rented shed

Our sample report

Integrated unit

₹511.53 lakh

44,000 pieces per day, 1,32,00,000 pieces per year

  • Plant and machinery₹223.02 lakh
  • Land and building₹184.71 lakh
  • Working capital margin₹43.95 lakh

Term loan ₹383.65 lakh (75%), promoter ₹127.88 lakh

Automated plant

₹10–20 crore

About 1–2 lakh pieces per day

  • Automatic assembly lines₹4–8 crore
  • Tubing extrusion and moulding₹2–4 crore
  • Land, building and clean room₹3–6 crore

Term loan with CGTMSE cover, subject to limits

Assembly unit and automated plant ranges are indicative. Machine origin (Indian, Chinese or European) moves the cost more than any other choice.

IV cannula project economics in our sample report

The sample unit runs 300 days a year at 44,000 pieces per day, starting at 60% of capacity and reaching 80% in Year 5. The selling price is taken at ₹9.34 per piece, ex-factory and excluding GST.

₹512 lakhTotal project cost
₹863 lakhSales in Year 3
₹72 lakhNet profit in Year 3
1.41Average DSCR
Cost of project (₹ lakh)
Land and site development29.33
Building and civil works155.38
Plant and machinery223.02
Other fixed assets29.53
Contingencies18.92
Preliminary and pre-operative11.40
Working capital margin43.95
Total511.53
Means of finance (₹ lakh)
Promoter's contribution (25%)127.88
Term loan from bank (75%)383.65
Cash credit limit (separate)131.84
Total project cost511.53

Term loan at 10.5% with a 6-month moratorium and 54 monthly instalments. All figures are illustrative.

IV cannula manufacturing process

An IV cannula is a soft plastic catheter that rides over a sharp steel needle. The needle makes the puncture and is withdrawn, leaving the catheter in the vein. Making one well is a matter of tight fits and clean handling.

  1. Moulding

    Injection moulding machines form the catheter hub, wings, port cap and flashback chamber from medical grade polypropylene and polycarbonate.

  2. Catheter tipping

    FEP tubing is cut to length and the tip is heat formed into a thin taper, so the catheter follows the needle into the vein without folding back.

  3. Needle preparation

    Stainless steel tubing is cut, ground to a sharp bevel, cleaned and coated with silicone so it slides through skin with low force.

  4. Clean room assembly

    The catheter is bonded to its hub, and the needle is fitted with its hub, flashback chamber and hydrophobic filter plug, then inserted into the catheter.

  5. Inspection and testing

    Samples from each batch are checked for tip finish, needle-to-catheter fit, leakage, flow rate and penetration force.

  6. Blister packing

    Each cannula is sealed in a medical paper blister and labelled with its gauge, colour code, batch and expiry.

  7. ETO sterilisation

    Packed cannulas are sterilised with ethylene oxide gas, aerated to remove residual gas and held until sterility results clear the batch.

Tip quality decides repeat orders: a rough or split catheter tip makes insertion painful and can peel back on the needle. Nurses notice it on the first box, so most process control effort goes into tipping and assembly.

Raw materials for IV cannula manufacturing

Most small units buy FEP tubing already extruded to size and make the rest in house. Tubing and needle tubing need certificates of biocompatibility from the supplier, and many plants keep about 45 days of stock because lead times are long.

Raw materialShare of costYear 3 (₹ lakh)
FEP catheter tubing30%113.14
Stainless steel needle tubing28%105.59
Medical grade polypropylene and polycarbonate20%75.42
Silicone valves, filter plugs and port caps12%45.26
Medical adhesive and silicone lubricant10%37.71
Total100%377.12

Blister paper and film are counted as packing, at 9.1% of sales in the sample, not as raw material.

Machinery for an IV cannula plant

Injection moulding machines are the largest machinery cost in the sample, followed by the assembly machines. Moulds are a separate line because each gauge needs its own cavities.

MachineWhat it doesSample cost (₹ lakh)
Injection moulding machinesMould hubs, wings, caps and chambers49.07
Multi-cavity hub, wing and cap mouldsSet part shape for each gauge31.22
Catheter cutting and tipping machineCuts tubing and forms the tip26.76
Needle grinding and siliconising unitBevels and coats the needle22.30
Cannula assembly machinesBond hubs and fit needle into catheter35.69
Blister packing machineSeals each piece in a sterile pack17.84
ETO sterilisation chamber with aerationSterilises packed batches22.30
Clean room HVAC with HEPA filtrationKeeps the assembly area clean17.84
Total plant and machinery223.02

Costs are the sample report's estimates for a 44,000 pieces per day unit. Get current quotations before you finalise.

Who buys IV cannulas in India

Almost every admitted patient gets an intravenous line, and many need a second cannula when the first one blocks or is resited. Demand therefore follows hospital beds, day-care procedures and emergency cases rather than seasons.

Hospitals buy a spread of gauges, from wide bores for trauma and transfusion to fine sizes for children. A new unit sells mainly through distributors in its first years, then qualifies for larger tenders once it has a licence history and supply record.

  • Private hospitals and nursing homes
  • Medical distributors and stockists
  • State and central government tenders, including GeM
  • Diagnostic, dialysis and day-care centres
  • Export buyers, where the plant holds the needed certification

Plan the product mix early: standard cannulas compete mostly on tender price. Safety cannulas and fine paediatric gauges are harder to make and usually sell higher, so they lift the average price per piece.

Licences and standards for IV cannula manufacturing

IV cannula is a regulated medical device, so the manufacturing licence, not the factory building, sets the date of first sale. These are the approvals as of October 2026.

Device classClass B (IV cannulae) in CDSCO's classification of 1 November 2017 under the Medical Devices Rules, 2017
Manufacturing licenceApply on Form MD-3 to the State Licensing Authority; the licence is granted on Form MD-5
Site auditA registered Notified Body audits the site before the licence is granted, within 90 days of the application
Test licenceForm MD-12 to the Central Licensing Authority to make small quantities for testing and evaluation before full licensing
Product standardIS/ISO 10555-5:2013 for over-needle peripheral catheters; ISO is preparing a new edition
Quality systemISO 13485 certification, commonly asked for in hospital tenders and by export buyers
GST5% under heading 9018 from 22 September 2025 (earlier 12%)
Business and siteUdyam and GST registration, State Pollution Control Board consent and factory licence where it applies

Mistakes that weaken an IV cannula project report

  • Taking MRP as the selling price

    The price printed on a cannula pack is many times what a distributor or tender pays. Sales must use ex-factory rates; the sample uses ₹9.34 per piece.

  • No time allowed for licensing

    A Class B licence needs a Notified Body audit first, and nothing can be sold until Form MD-5 is issued. Interest and salaries in that gap belong in pre-operative cost.

  • Forgetting the sterilisation hold

    ETO aeration and sterility testing keep each batch in stock for days after packing. Finished goods stock and working capital must allow for it.

  • Planning for one gauge only

    Buyers order a range of colour-coded sizes. Each gauge needs its own moulds and setup time, which lowers real output against rated capacity.

  • Assuming no rejections

    Tips, bonds and needles fail inspection at some rate, mostly while a new line settles. Raw material use should cover rejected pieces.

How NPCS helps you set up an IV cannula unit

  • Capacity and gauge mixSize daily output and the range of gauges to suit your buyers and budget.
  • Machinery and clean roomCompare assembly, tipping and sterilisation options and collect quotations.
  • Bank-ready project reportProjections, DSCR and working capital in the format your lender expects.
  • Licensing roadmapThe MD-3 application, Notified Body audit and other approvals, mapped to your project schedule.

NPCS's client list includes 5 assignments for IV cannula projects and 75 across medical devices, for entrepreneurs, banks and companies in India and abroad.

What's inside the iv cannula sample report

  1. Introduction
  2. Uses and applications
  3. Market potential
  4. Manufacturing process
  5. Raw materials
  6. Plant and machinery
  7. Land, building and utilities
  8. Manpower
  9. Licences and approvals
  10. Project cost and means of finance
  11. Working capital
  12. Projected profitability
  13. Cash flow statement
  14. Projected balance sheet
  15. Depreciation
  16. Term loan repayment
  17. Debt service coverage
  18. Break-even analysis
  19. Financial ratios
  20. Key assumptions
  21. Conclusion
  22. Monthly loan repayment schedule

19 pages, five-year projections, illustrative figures.

Open sample report

Free sample or a report for your project?

What you getFree sampleNPCS report for your project
Capacity and locationTypical unitYour capacity, site and state
FiguresIllustrativeBuilt on current prices and quotations
Machinery suppliers and quotationsNoYes
Market survey for your regionNoYes
Bank or scheme format (PMEGP, term loan)NoYes
Use for a loan applicationNoYes

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IV Cannula project report: frequently asked questions

What is the IV cannula manufacturing plant cost in India?

An assembly unit making 10,000–20,000 pieces a day needs roughly ₹1.5–3 crore, and a highly automated plant with its own tubing extrusion can need ₹10–20 crore. Our sample report models a 44,000 pieces per day unit at ₹511.53 lakh. These ranges are indicative; your own report works out the cost for your capacity, automation level and location.

Which licence is needed to manufacture IV cannula in India?

IV cannula is a Class B medical device under the Medical Devices Rules, 2017. You apply on Form MD-3 to your State Licensing Authority and receive the manufacturing licence on Form MD-5. A registered Notified Body must audit the site before the licence is granted. Udyam, GST and pollution board consent are also needed.

What raw materials are used to make an IV cannula?

The catheter is made from FEP tubing (some makers use polyurethane) and the introducer needle from stainless steel tubing. The hub, wings, port cap and flashback chamber are moulded from medical grade polypropylene and polycarbonate. Silicone valves, filter plugs, adhesive and silicone lubricant complete it. In our sample report FEP tubing is the largest raw material cost at 30%.

Is IV cannula manufacturing profitable?

It can be, at volume. In our illustrative sample a 44,000 pieces per day unit earns ₹72 lakh net profit on ₹863 lakh sales in Year 3. That is a 14% return on investment, with break-even at 49% of capacity. Margins are thin per piece, so profit depends on rejection rates, tender prices and how quickly buyers pay.

Can I get a PMEGP or bank loan for an IV cannula unit?

Most IV cannula units take an MSME term loan from a bank. PMEGP covers manufacturing projects only up to ₹50 lakh, which is usually below the cost of a licensed unit with a clean room and sterilisation. CGTMSE can give collateral-free guarantee cover on eligible loans up to ₹10 crore. Lenders ask for a project report with projections and DSCR.

What GST rate applies to IV cannula?

IV cannulas fall under tariff heading 9018, medical and surgical instruments and appliances. The GST Council cut the rate on this heading from 12% to 5% with effect from 22 September 2025. Check the exact tariff item for your product with your tax adviser, because the rate decides the price you quote to hospitals and distributors.

Is the sample report free and can I use it for a loan?

The sample is free to view and download. It shows the format and depth of an NPCS report, but its figures are representative and not taken from a real project. Do not submit it to a bank. For a loan, NPCS prepares a report for your own capacity, location and lender.

Sources and references

  1. Classification of medical devices and in vitro diagnostic medical devices under the Medical Devices Rules, 2017 (notice of 1 November 2017)Central Drugs Standard Control Organisation, checked Oct 2026
  2. Medical Devices Rules, 2017Central Drugs Standard Control Organisation, checked Oct 2026
  3. IS/ISO 10555-5:2013 Intravascular catheters: over-needle peripheral cathetersBureau of Indian Standards, checked Oct 2026
  4. Recommendations of the 56th meeting of the GST Council (press release)GST Council, Government of India, checked Oct 2026
  5. PMEGP (Prime Minister Employment Generation Programme)MSME Department, Government of Uttar Pradesh, checked Oct 2026
  6. Credit Guarantee Fund Trust for Micro and Small EnterprisesCGTMSE, checked Oct 2026
Ajay Kumar Gupta, founder of NPCS

Who prepares NPCS reports

The NPCS project team, led by Ajay Kumar Gupta

This page and its sample report are prepared and reviewed by the NPCS project team, which has written techno-economic feasibility studies and detailed project reports since 1994.

Ajay Kumar Gupta founded Niir Project Consultancy Services (NPCS) and leads the organisation. With 40 years of experience in MSME project consulting, he has built the team that has delivered more than 28,000 project reports for clients worldwide, helping entrepreneurs plan and finance profitable manufacturing businesses.

Ajay Kumar Gupta on LinkedIn

Published
Last updated
Next review
Oct 2027
Reviewed by
NPCS project team

This page is reviewed every 12 months, or sooner when scheme limits, GST rates, BIS rules or pollution categories change. The sample report is illustrative: its figures are generated from industry-typical ratios for a unit of this size, checked so every statement balances, and are not taken from any client project.

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Reports are prepared in the format banks and PMEGP offices ask for, with five-year projections, DSCR and break-even.

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Illustrative sample. Figures are representative and not from a real project.

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