A reader asked:

“Is any licence required for cutting and packing rolled cotton or cotton bandage? Many companies do not take a licence because they consider it a fabric product.”

The answer depends mainly on what type of cotton you are processing and how you intend to sell it.

If ordinary cotton or textile fabric is cut and packed for general, cosmetic, cleaning or industrial purposes without any medical intended use, medical-device licensing may not apply.

However, if the product is sold as:

• Absorbent cotton wool
• Surgical cotton
• Cotton wool for wound dressing
• Medical cotton roll
• Dressing cotton
• Cotton intended for hospitals, clinics or first-aid use

then it should not simply be treated as an ordinary fabric product.

Absorbent cotton wool intended for medical use is regulated as a medical device in India.

Quick Answer

Non-Sterile, Non-Measuring Absorbent Cotton Wool

If you purchase bulk absorbent cotton, cut it into smaller medical cotton rolls, label it and sell it under your own name or brand, this activity should be treated as manufacturing/repacking of a medical device.

For a Class A non-sterile and non-measuring medical device, a full MD-5 manufacturing licence is generally not required under the present exemption.

However, the manufacturer must obtain the applicable Class A medical-device registration number through the CDSCO online system and comply with the Medical Devices Rules, 2017.

Sterile Cotton

If the product is supplied as sterile, the simplified Class A non-sterile exemption does not apply.

A proper medical-device manufacturing licence and applicable quality-system requirements will generally be required.

Medicated Cotton

If cotton is impregnated or treated with an antiseptic, medicinal ingredient or other active substance, do not assume that the ordinary non-sterile cotton registration is sufficient.

Its classification and licensing should be confirmed with the concerned State Licensing Authority/CDSCO before manufacturing.

Is Cotton Roll a Fabric Product or Medical Device?

Both descriptions can be correct depending on the intended use.

Ordinary Textile Cotton

Cotton sold for purposes such as:

• Cleaning
• Craft
• Cosmetic use
• Industrial use
• Upholstery
• General household use

may remain an ordinary textile or consumer product if no medical intended use or medical claim is made.

Absorbent Surgical Cotton

If the same product is labelled or promoted for:

• Cleaning wounds
• Absorbing blood or body fluids
• Surgical dressing
• First aid
• Hospital use
• Clinical procedures

its intended purpose brings it within the medical-device regulatory framework.

Therefore, regulation depends not only on the physical material but also on:

• Intended use
• Labelling
• Claims
• Packaging
• Sterility
• Product specifications

Is Cutting and Repacking Considered Manufacturing?

Yes, it can be.

The legal meaning of manufacture is broader than producing cotton from raw fibre.

Manufacturing may include activities such as:

• Cutting
• Breaking bulk packs
• Finishing
• Repacking
• Packing
• Labelling
• Adapting a product for sale or distribution

For example:

Suppose you purchase a 10 kg bulk roll of absorbent surgical cotton.

You then:

1. Cut it into 50 g, 100 g and 500 g rolls.
2. Pack each roll separately.
3. Print your company name and brand.
4. Sell the product as surgical or absorbent cotton.

You are not merely acting as a trader.

You are converting bulk medical-device material into finished saleable packs.

This activity should therefore be brought under the applicable manufacturing/registration framework.

Current Regulatory Position for Non-Sterile Absorbent Cotton

Medical devices in India are regulated under the Medical Devices Rules, 2017.

Devices are classified according to risk:

Class	Risk
Class A	Low risk
Class B	Low-moderate risk
Class C	Moderate-high risk
Class D	High risk

Absorbent cotton wool intended as a non-sterile medical dressing falls within the low-risk Class A category.

For Class A devices that are both non-sterile and non-measuring, the Government introduced a simplified system.

These products are:

Exempt from the normal medical-device manufacturing licensing regime, but not exempt from regulation.

The manufacturer must complete online registration.

What Registration Is Required?

For qualifying Class A non-sterile, non-measuring devices, the manufacturer registers the:

• Manufacturing site
• Device
• Intended use
• Construction/material details
• Relevant specifications

through the designated online medical-device system.

A registration number is then generated.

The manufacturer must also self-certify compliance with applicable safety, performance and standards requirements.

Therefore, saying:

“No licence is required, so anyone can manufacture and pack surgical cotton”

would be misleading.

A more accurate statement is:

“Qualifying non-sterile, non-measuring Class A medical devices are exempt from the full manufacturing licence, but registration and regulatory compliance are still required.”

Is Form MD-5 Required?

For a qualifying Class A non-sterile and non-measuring absorbent cotton product, the current exemption means that a normal MD-5 licence is generally not required.

However, the exemption applies only when the device is genuinely:

• Class A
• Non-sterile
• Non-measuring

If any one of these conditions changes, a different regulatory pathway may apply.

For example:

Non-Sterile Cotton Wool

Class A non-sterile/non-measuring registration route may apply.

Sterile Cotton Wool

Full medical-device licensing requirements may apply.

Medicated Cotton

Classification should be independently confirmed.

Cotton Incorporated Into a Higher-Risk Device

The applicable classification may change according to intended use and device rules.

What Information Is Required for Class A Registration?

The manufacturer should be prepared with information such as:

• Name and address of manufacturing site
• Generic name of device
• Brand name
• Model or pack details where applicable
• Intended use
• Material of construction
• Dimensions or sizes where applicable
• Shelf life where applicable
• Device classification
• Compliance declaration
• Applicable standards
• Safety and performance checklist
• Manufacturer undertaking

The exact online requirements should be checked at the time of application.

Do I Need a Separate Registration for Different Pack Sizes?

Suppose you sell:

• 25 g
• 50 g
• 100 g
• 200 g
• 400 g
• 500 g

under the same absorbent cotton product.

Whether all pack sizes can be grouped under a single device registration or require separate listing details should be confirmed during CDSCO registration according to the current device-grouping rules.

Do not assume that one registration number automatically covers every:

• Brand
• Variant
• Sterility status
• Intended use

Requirements for the Manufacturing/Packaging Premises

Even when the simplified registration route applies, the premises should be suitable for producing a medical-use product.

Important considerations include:

• Clean manufacturing area
• Controlled cutting area
• Hygienic packing area
• Protection from dust
• Pest-control programme
• Proper raw-material storage
• Finished-goods storage
• Waste handling
• Cleaning procedures
• Equipment maintenance
• Employee hygiene
• Batch identification
• Traceability

Absorbent cotton intended for wound use should not be cut and packed in an uncontrolled dusty textile area merely because it is non-sterile.

Raw Material Requirements

Bulk absorbent cotton should be purchased from a reliable supplier.

Maintain documents such as:

• Purchase invoice
• Supplier details
• Material specification
• Test certificate
• Batch or lot number
• Incoming quality-control record

Important product characteristics may include:

• Absorbency
• Cleanliness
• Fibre quality
• Acidity or alkalinity
• Water-soluble substances
• Foreign matter
• Moisture
• Whiteness
• Applicable microbiological parameters

The exact testing specification should follow the applicable standard adopted for the product.

Is Testing Required?

The manufacturer is responsible for ensuring that the finished product conforms to applicable standards and declared specifications.

Testing may include:

• Identification
• Absorbency
• Physical characteristics
• Foreign matter
• Chemical limits
• Bioburden where relevant
• Packaging integrity

Testing may be performed through an appropriate internal or external laboratory depending on the regulatory and quality-system arrangement.

Labelling Requirements

A medical-device cotton pack should not be labelled like an ordinary textile packet.

Applicable labelling requirements may include:

• Name of device
• Intended use
• Manufacturer name
• Manufacturing-site address
• Net weight
• Batch or lot number
• Manufacturing date
• Expiry or shelf-life details where applicable
• Storage condition
• Non-sterile declaration where appropriate
• Registration/licence details required under the applicable rules
• Warnings or precautions
• Customer-care information

Claims should match the actual registered intended use.

Can I Write “Sterile” on the Pack After Simple Repacking?

No.

Sterile is a regulated product characteristic.

You cannot label a cotton roll:

STERILE

unless the product has undergone a validated sterilization process and complies with the applicable sterile medical-device manufacturing requirements.

Sterilization may involve methods such as:

• Ethylene oxide
• Radiation
• Other validated processes

The process, packaging and shelf-life system must be validated.

Simply packing cotton in a sealed pouch does not make it sterile.

What About Medicated Cotton?

Medicated cotton requires particular care.

Examples might include cotton impregnated with:

• Antiseptic
• Alcohol
• Iodine
• Chlorhexidine
• Another medicinal substance

The regulatory category may depend on:

• Active ingredient
• Intended action
• Medical claim
• Concentration
• Whether the principal intended action is physical or pharmacological

Do not manufacture a medicated cotton product based only on the registration used for ordinary absorbent cotton.

Confirm its classification and licensing route before production.

Cotton Bandage vs Absorbent Cotton Wool

These products should not automatically be treated as the same item.

Cotton Bandage

A bandage is normally a woven or knitted material used for:

• Holding a dressing
• Providing support
• Covering a wound
• Compression, depending on type

Examples include:

• Open-wove bandage
• Cotton crepe bandage
• Gauze bandage
• Calico bandage

Absorbent Cotton Wool

Cotton wool primarily functions as an absorbent material.

Both may fall under medical-device regulation when intended for medical use, but their:

• Specifications
• Standards
• Intended uses
• Product registrations

can differ.

What If I Only Buy Finished Packs and Sell Them?

If you purchase fully packed and labelled finished medical cotton from an authorised manufacturer and sell it without:

• Opening
• Cutting
• Repacking
• Relabelling
• Changing the product

you are acting as a trader/distributor rather than as the manufacturer.

Sale and distribution of medical devices have separate premises-registration requirements under the Medical Devices Rules.

Therefore, manufacturing registration and seller/distributor registration should not be confused.

What If I Buy Bulk Cotton and Put My Own Brand on It?

If you:

• Purchase bulk product
• Cut it
• Change the quantity
• Repack it
• Apply your own label
• Sell it as a medical cotton roll

you should not regard yourself as a simple marketing company.

The activity involves manufacturing/repacking steps and should comply with the medical-device requirements applicable to the finished product.

A safer alternative for a marketing company is to use a properly registered/licensed contract manufacturer to manufacture and pack the product under its brand.

Is BIS Certification Required?

Absorbent cotton and medical textiles may also be subject to applicable Bureau of Indian Standards specifications.

The company should check:

• Current BIS standard
• Whether certification is mandatory for the exact product
• Tender requirements
• Hospital procurement specifications
• Government-supply requirements

A CDSCO registration and BIS conformity serve different purposes.

One should not automatically be treated as a substitute for the other.

Step-by-Step Procedure to Start Cutting and Packing Absorbent Cotton

Step 1: Define the Product

Decide whether the product is:

• Medical absorbent cotton
• Cosmetic cotton
• Industrial cotton
• Sterile surgical cotton
• Non-sterile surgical cotton
• Medicated cotton

Step 2: Confirm Classification

Confirm:

• Intended use
• Risk class
• Sterile/non-sterile status
• Measuring/non-measuring status

Step 3: Finalise the Premises

Arrange a clean and suitable cutting and packing area.

Step 4: Finalise Raw Material

Purchase compliant absorbent cotton from an approved supplier.

Step 5: Prepare Specifications

Create specifications for:

• Raw cotton
• Finished cotton roll
• Packaging
• Labels

Step 6: Register the Device

For eligible Class A non-sterile/non-measuring products, obtain the appropriate CDSCO online registration.

Step 7: Prepare SOPs

Prepare procedures for:

• Material receipt
• Cutting
• Weighing
• Packing
• Labelling
• Cleaning
• Testing
• Batch numbering
• Complaint handling
• Recall
• Record retention

Step 8: Approve Packaging

Ensure the pack protects the cotton from:

• Dust
• Moisture
• Contamination
• Damage

Step 9: Approve the Label

Verify regulatory declarations before printing.

Step 10: Start Commercial Production

Maintain batch-wise records and traceability.

Documents You Should Maintain

Important records may include:

• CDSCO registration
• Business registration
• GST documents
• Premises documents
• Raw-material invoices
• Supplier qualification
• Raw-material COA
• Finished-product specifications
• Test reports
• Batch records
• Packing records
• Artwork
• Labels
• Sales invoices
• Complaint register
• Recall procedure
• Training records
• Cleaning records

Answer to the Original Query

If you are simply cutting ordinary cotton fabric that is not intended, labelled or marketed for medical use, medical-device registration may not apply.

However:

If you purchase absorbent surgical cotton in bulk, cut it into smaller rolls, pack it and sell it as surgical/medical cotton, the activity should be treated as manufacture/repacking of a medical device.

For a Class A non-sterile, non-measuring absorbent cotton wool product, the current rules provide an exemption from the full medical-device manufacturing licence, but the manufacturer must obtain the prescribed CDSCO online registration and comply with the Medical Devices Rules.

If the product is:

• Sterile
• Medicated
• Measuring
• Combined with another regulated product

a different or higher regulatory requirement may apply.

Do not start manufacturing only because other local companies are operating without visible licences or registrations.

Their compliance position does not determine your legal obligations.

Frequently Asked Questions

1. Is absorbent cotton wool a medical device?

When intended and marketed for surgical dressing or other medical purposes, absorbent cotton wool falls within the medical-device regulatory framework.

2. Is MD-5 required for non-sterile absorbent cotton?

A qualifying Class A non-sterile and non-measuring device is currently exempt from the normal manufacturing-licence regime, but CDSCO registration remains required.

3. Does cutting bulk cotton amount to manufacturing?

Cutting, breaking bulk quantities, packing and labelling a regulated product for sale may constitute manufacturing activity.

4. Can I sell medical cotton without registration because it is non-sterile?

Non-sterile does not mean unregulated. The Class A registration requirements still apply.

5. Can ordinary fabric cotton be sold without a medical-device registration?

If it genuinely has no medical intended use or claims, medical-device rules may not apply. Other consumer, textile, packaging and commercial laws may still apply.

6. Is sterile cotton covered by the same exemption?

No. The exemption is specifically for Class A devices that are both non-sterile and non-measuring.

7. Can a marketing company buy bulk cotton and repack it?

Repacking and relabelling a medical device may amount to manufacturing. The activity should be conducted under the applicable regulatory registration/licensing framework.

8. Can I write “surgical cotton” on ordinary cotton?

Only if the product meets the applicable medical-device specifications and regulatory requirements for its intended medical use.

9. Is a drug licence required for medicated cotton?

The classification may be different when a medicinal substance is incorporated. Obtain written regulatory confirmation before manufacturing.

10. Who regulates medical devices in India?

Medical devices are regulated under the Drugs and Cosmetics Act and Medical Devices Rules, 2017 through CDSCO and the relevant Central/State Licensing Authorities.

11. Is packing alone considered manufacturing?

Packing and labelling a regulated product for sale can form part of manufacturing under the Drugs and Cosmetics Act.

12. Should I take written clarification before investing?

Yes. If the exact product classification is uncertain, submit the intended-use statement, composition, sterility status, manufacturing process and proposed label to the relevant State Drugs Control authority or medical-device regulatory professional before purchasing machinery.

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