An MD 42 licence is commonly used to describe the registration certificate issued in Form MD-42 for businesses selling, stocking, exhibiting, offering for sale or distributing medical devices and in vitro diagnostic medical devices.

The applicant files Form MD-41 with the concerned State Licensing Authority. MD-42 is commonly called a medical device wholesale licence, but it is technically a registration certificate under the Medical Devices Rules, 2017.

What Is MD 42 Registration?

MD 42 registration is required for a trader or distributor that deals exclusively in medical devices.

It may permit the registered business to:

• Stock medical devices.
• Sell medical devices.
• Exhibit medical devices.
• Offer medical devices for sale.
• Distribute medical devices.
• Supply devices to hospitals.
• Supply devices to clinics.
• Supply devices to laboratories.
• Supply devices to healthcare institutions.
• Supply medical devices to authorised dealers.
• Handle eligible IVD products.

CDSCO clarifies that a trader or distributor exclusively engaged in the stock, sale and distribution of medical devices must obtain a Registration Certificate in Form MD-42.

MD 42 Licence and Medical Device Wholesale License

An MD 42 licence is commonly called a medical device wholesale licence.

It is different from:

Approval	Main purpose
Form MD-42 registration	Sale, stock, exhibition, offer for sale and distribution of medical devices
Medical-device import licence	Import of regulated devices into India
Medical-device manufacturing licence	Manufacturing medical devices in India
Wholesale drug licence	Wholesale sale and distribution of drugs
Retail drug licence	Retail sale of drugs through a pharmacy

An MD-42 certificate does not automatically permit import or manufacture of medical devices.

CDSCO MD 42

Businesses search for CDSCO MD 42 because CDSCO administers the medical-device regulatory framework. However, Form MD-42 is granted by the concerned State Licensing Authority.

The relevant authority depends on the location of the actual distribution or storage premises.

Premises location	Authority
Delhi	Delhi State Licensing Authority
Noida or Ghaziabad	Uttar Pradesh State Licensing Authority
Gurugram or Faridabad	Haryana State Licensing Authority
Other locations	State Licensing Authority of that state

Who Needs an MD 42 Certificate?

An MD-42 registration certificate may be relevant for:

• Medical-device wholesalers.
• Medical-device distributors.
• Medical-device dealers.
• Medical-device stockists.
• Surgical-equipment suppliers.
• Hospital-equipment suppliers.
• Diagnostic-device distributors.
• IVD distributors.
• Medical-device traders.
• Institutional suppliers.
• E-commerce sellers of medical devices.
• Local distributors of imported devices.
• Authorised distributors of manufacturers.
• Suppliers to hospitals, clinics and laboratories.

The business should first confirm that the products qualify as medical devices or IVDs under the applicable framework.

MD 42 Registration Online

MD 42 registration online is filed through the designated Medical Devices online system.

The applicant submits Form MD-41, uploads documents and pays the prescribed fee to the concerned State Licensing Authority.

MD 42 Online Application Process

1. Confirm whether the business exclusively handles medical devices.
2. Identify the state of the actual storage or distribution premises.
3. Prepare the MD 42 licence product list.
4. Arrange suitable storage premises.
5. Collect business and product documents.
6. Create an applicant profile on the Medical Devices portal.
7. Select Form MD-41.
8. Enter firm and premises details.
9. Add product and manufacturer information.
10. Upload supporting documents.
11. Pay the prescribed fee.
12. Submit the application.
13. Respond to any deficiency or inspection request.
14. Download the MD-42 certificate after approval.

CDSCO identifies the online system for applications relating to the sale, stock, exhibition, offer for sale and distribution of medical devices.

Documents Required for MD 42 Licence

Common documents include:

• PAN card.
• GST registration certificate.
• Certificate of incorporation.
• Memorandum of Association.
• Articles of Association.
• Partnership deed.
• LLP agreement.
• Proprietorship declaration.
• Board resolution.
• Authorisation letter.
• Registered-office proof.
• Premises ownership proof.
• Rent agreement.
• Lease deed.
• Owner NOC.
• Site plan.
• Storage-layout plan.
• Refrigerator details, where applicable.
• Temperature-monitoring details, where applicable.
• Manufacturer authorisation.
• Importer authorisation.
• Distributor authorisation.
• Responsible-person details.
• Medical-device product list.
• Storage and handling procedure.
• Complaint-handling procedure.
• Product-recall procedure.
• Purchase and distribution record procedure.
• Fee-payment receipt.

The entity name, premises address, product list and manufacturer or importer authorisation should be consistent throughout the application.

MD 42 License Product List

The MD 42 license product list should clearly identify all devices proposed to be stocked, sold or distributed.

The list may include:

• Device name.
• Brand name.
• Model number.
• Device category.
• Device class, where applicable.
• Manufacturer name.
• Importer name, where applicable.
• Country of origin.
• Storage conditions.
• Product licence information, where applicable.
• Manufacturer authorisation details.

Examples include:

• Surgical gloves.
• Syringes.
• Thermometers.
• Blood-pressure monitors.
• Pulse oximeters.
• Nebulisers.
• Glucose-monitoring devices.
• Diagnostic kits.
• IVD products.
• Catheters.
• Surgical instruments.
• Orthopaedic implants.
• Infusion pumps.
• Hospital beds.
• Wheelchairs.
• Patient-monitoring devices.

The product list should match the actual products stored and distributed by the business.

MD42 Drug License

Businesses often search for the phrase MD42 drug license, but MD-42 is not the same as a conventional drug licence.

Term	Meaning
MD-42	Registration certificate for sale and distribution of medical devices
Form 20 or 21	Drug retail licence, depending on product category
Form 20-B or 21-B	Drug wholesale licence, depending on product category
Drug manufacturing licence	Permission to manufacture drugs
Medical-device import licence	Permission to import regulated medical devices

A business dealing with both drugs and medical devices may need separate approvals for each activity.

Medical Device Wholesale Licence Premises

The premises should support safe storage and distribution.

Important arrangements may include:

• Clean storage area.
• Suitable racks and shelving.
• Protection from heat and moisture.
• Temperature control, where required.
• Segregation of damaged products.
• Segregation of expired products.
• Stock traceability.
• Purchase records.
• Distribution records.
• Complaint records.
• Recall records.
• Manufacturer instructions.
• Product handling procedures.

MD 42 Licence Validity

The Form MD-42 registration certificate is generally valid in perpetuity, subject to payment of the applicable retention fee at the required five-year intervals.

The certificate may be suspended or cancelled if the holder fails to comply with the Medical Devices Rules, registration conditions or regulatory directions.

The holder should maintain reminders for:

• Retention-fee payment.
• Product-list updates.
• Premises changes.
• Manufacturer-authorisation renewal.
• Responsible-person changes.
• Complaint and recall review.
• Record maintenance.

MD 42 Licence Consultant

An MD 42 licence consultant can help applicants identify the correct registration route and prepare state-specific documentation.

Agile Regulatory can assist with:

• MD 42 licence assessment.
• MD 42 registration.
• MD 42 licence online application.
• Medical device wholesale license planning.
• Product-list preparation.
• Device classification review.
• Manufacturer-authorisation review.
• Importer-authorisation review.
• Storage-premises assessment.
• Uttar Pradesh MD-42 registration.
• Ghaziabad MD-42 registration.
• CDSCO MD 42 support.
• Deficiency-response support.
• Retention-fee planning.
• Post-registration compliance.

Common MD 42 Registration Mistakes

Businesses should avoid:

• Applying in the wrong state.
• Using a virtual address instead of actual storage premises.
• Treating MD-42 as an import licence.
• Treating MD-42 as a manufacturing licence.
• Filing an incomplete product list.
• Using invalid manufacturer authorisation.
• Storing devices without suitable conditions.
• Failing to maintain purchase and distribution records.
• Not tracking lot or expiry information, where relevant.
• Failing to maintain complaint and recall procedures.
• Missing retention-fee requirements.
• Not updating changed premises or product information.

Conclusion

An MD 42 licence is a registration certificate for businesses exclusively engaged in the sale, stock, exhibition, offer for sale or distribution of medical devices and IVDs. The applicant files Form MD-41 online and receives Form MD-42 from the concerned State Licensing Authority.

A complete product list, suitable storage facilities, valid manufacturer or importer authorisation and accurate business records are essential for successful MD 42 registration. Businesses should also distinguish MD-42 from drug licences, manufacturing licences and medical-device import licences.

Frequently Asked Questions

1. What is an MD 42 licence?

An MD-42 licence is the commonly used name for the Form MD-42 registration certificate issued for the sale, stock, exhibition, offer for sale and distribution of medical devices.

2. Is MD-42 a medical device wholesale license?

Yes, it is commonly called a medical device wholesale license. Formally, it is a registration certificate under the Medical Devices Rules, 2017.

3. How can I apply for MD 42 registration online?

Apply through the Medical Devices online portal by filing Form MD-41, uploading documents, paying the prescribed fee and submitting the application to the concerned State Licensing Authority.

4. What should be included in the MD 42 license product list?

The list should include device name, brand, model number, category, manufacturer, importer where applicable, country of origin, storage conditions and authorisation details.

5. Is MD-42 the same as a drug licence?

No. MD-42 applies to medical-device sale and distribution, while drug licences apply to the sale, distribution or manufacture of medicines. Separate approvals may be required for both activities.