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ISI mark licence (Scheme-I)

Medical Textiles BIS Certification

6 medical textiles products need an ISI mark licence from BIS before they can be made, imported or sold in India. Find your product, its Indian Standard and the order that made it compulsory.

Independent private consultancy. Aaditech is not BIS or any government department and is not affiliated with or endorsed by them. Licences are granted only by the authority, and you can apply directly on its portal. Our consultancy fees are separate from official fees.

Medical Textiles under compulsory BIS certification

6 products across 6 Indian Standards. Open a product for its scope, order details and FAQs.

ProductIndian StandardOrder
Sanitary Napkins IS 5405 : 2019 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)
Disposable Baby Diaper IS 17509 : 2021 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)
Reusable Sanitary Pads and Period Panties IS 17514 : 2021 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)
Shoe Covers IS 17349 : 2020 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)
Dental Bib or Napkins IS 17354 : 2020 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)
Bed Sheet and Pillow Cover IS 17630 : 2021 Medical Textiles (Quality Control) Order, 2023, S.O. 4247(E)

How BIS certification works for medical textiles

  1. Confirm the exact Indian Standard and the varieties to cover
  2. Get the product tested at a BIS-recognised lab (simplified procedure) or arrange BIS sampling
  3. Apply on Manak Online with factory, quality-control and test documents
  4. BIS factory inspection and sample verification
  5. Grant of licence, then marking with the ISI mark and CM/L number

Testing. BIS inspects the factory and has samples tested to the full Indian Standard at a BIS or BIS-recognised laboratory. After grant, the factory keeps testing production under the Scheme of Inspection and Testing, and BIS draws factory and market samples.

Timeline. BIS targets 30 days under the simplified procedure (applying with a recent lab test report) and 90 days under the normal procedure. Overseas factories under FMCS typically take around 6 months.

Fees. Application fee ₹1,000 and annual licence fee ₹1,000, inspection charges of ₹7,000 per man-day, testing charges, and an annual minimum marking fee set for each Indian Standard (with concessions for micro and small units).

Mark on product. The ISI Standard Mark with the IS number and the CM/L-XXXXXXXXXX licence number.

Frequently asked questions

Is BIS certification mandatory for medical textiles?

Yes, for the 6 products listed on this page. Each is covered by a Quality Control Order, so it needs an ISI mark licence before it is manufactured, imported, sold or stored for sale in India. Check the exact product and Indian Standard in the table.

How long does BIS certification take for medical textiles?

BIS targets 30 days under the simplified procedure (applying with a recent lab test report) and 90 days under the normal procedure. Overseas factories under FMCS typically take around 6 months.

What does BIS certification cost?

Application fee ₹1,000 and annual licence fee ₹1,000, inspection charges of ₹7,000 per man-day, testing charges, and an annual minimum marking fee set for each Indian Standard (with concessions for micro and small units).

Can overseas manufacturers of medical textiles apply?

The licence is granted to the manufacturer for a specific factory and product. Indian factories apply under Scheme-I; overseas factories apply under the Foreign Manufacturers Certification Scheme (FMCS) and must nominate an Authorised Indian Representative.

Source: BIS list of products under compulsory certification (Scheme-I), checked October 2026. See the full BIS product list for other categories.

Not sure which certification your product needs?

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