Mandatory BIS Standard
ISI Mark for Medical Equipment Manufacturer
- Minimum marking fee per year
- ₹11,600 – ₹59,000
- Micro to large firms
- HSN codes
- 90251110, 90189099
- Check the code with customs
Medical equipment license in India requires compliance with CDSCO regulations and applicable BIS/IS standards. Devices are classified and registered based on risk level under the Medical Devices Rules 2017.
Applicable Indian Standards for ISI Mark for Medical Equipment Manufacturer
| IS number | Product |
|---|---|
| IS 3055 (Part 1) | Clinical thermometers :Part1 Solid stem typeHSN 90251110 |
| IS 3055 (Part 2) | Clinical thermometers :Part 2 Enclosed scale typeHSN 90251110 |
| IS 7620 (Part 1) | Diagnostic Medical X-Ray EquipmentHSN 90189099 |
- Legal order: Clinical Thermometers (QC) Order, 2001 - GSR 843(E)
- Legal order: Diagnostic Medical X-Ray Equipment - AERB/443/39 MDX/3509/94
Minimum marking fee by firm size
You pay BIS a minimum marking fee every year. Micro, small and medium firms (with Udyam registration) pay less. BIS also works out a fee from the unit rate and your production. You pay whichever amount is higher.
| IS number | Large | Medium | Small | Micro | Unit rate |
|---|---|---|---|---|---|
| IS 3055 (Part 1) | ₹59,000 | ₹48,000 | ₹29,500 | ₹11,800 | ₹0.40 per piece |
| IS 3055 (Part 2) | ₹59,000 | ₹48,000 | ₹29,500 | ₹11,800 | ₹0.50 per piece |
| IS 7620 (Part 1) | ₹58,000 | ₹47,000 | ₹29,000 | ₹11,600 | ₹260 per piece |
- Other BIS charges
- ₹9,000 for every ISI mark product: application charge ₹1,000 · licence fee ₹1,000 · audit charges ₹7,000
- Foreign manufacturers
- Get a detailed quote
- Our consulting fee
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All prices are a guide only and do not include GST. Rules and dates can change, so check the latest notice before you apply. Ask us for an up-to-date quote.
Common questions
Are BIS and ISI the same?
No, BIS (Bureau of Indian Standards) is the regulatory body, while ISI (Indian Standards Institute) mark certifies product quality per BIS standards. ISI is a certification under BIS.
Is a drug license required for medical equipment?
In India, certain medical devices are classified as drugs under the Drugs and Cosmetics Act, requiring a CDSCO license. Non-drug category devices do not need a drug license.
What is the ISO standard for medical equipment?
ISO 13485 is the globally recognized standard for medical devices, ensuring compliance with regulatory and quality management requirements for design, production, and distribution of medical equipment.
Is BIS mandatory for medical devices?
Yes, for certain medical devices notified by the government, BIS certification is mandatory to ensure safety and quality, especially under the Medical Device Rules, 2017 in India.
What is the ISO for medical device manufacturers?
ISO 13485 is the key standard for medical device manufacturers, focusing on quality management systems, risk management, and regulatory compliance in the design, production, and distribution of medical devices.
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