MD 42 registration is a regulatory registration process for businesses engaged exclusively in the sale, stock, exhibition, offer for sale or distribution of medical devices and in vitro diagnostic medical devices in India.

The registration certificate is issued in Form MD-42 after the applicant files an online application in Form MD-41 with the concerned State Licensing Authority. It is commonly called an MD 42 licence or a medical device wholesale licence.

What Is MD 42 Registration?

MD 42 registration is the registration certificate required for a trader or distributor that exclusively handles medical devices.

The certificate may permit an eligible 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 authorised dealers.
• Supply diagnostic and IVD products.
• Operate as a medical-device wholesaler.

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

What Is an MD 42 Licence?

An MD 42 licence is the commonly used name for the Form MD-42 Registration Certificate.

Technically, MD-42 is not a manufacturing licence or an import licence. It is a registration certificate for sales and distribution activity under the Medical Devices Rules, 2017.

A business importing medical devices may need an applicable import licence or authorised-agent arrangement in addition to MD-42 registration for local storage and distribution.

CDSCO MD 42 and State Licensing Authority

Businesses frequently search for , but the certificate is issued by the concerned State Licensing Authority.

The state authority is determined by the location of the actual distribution or storage premises.

A Ghaziabad-based medical-device distributor should apply under Uttar Pradesh jurisdiction. A Delhi office address cannot be used in place of the actual Ghaziabad storage premises.

Who Needs an MD 42 Certificate?

An MD 42 certificate may be required by:

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

The applicant should confirm whether its products are classified as medical devices before filing.

MD 42 Registration Online

The MD 42 registration online process is completed through the Medical Devices online portal.

The applicant files Form MD-41 with the requisite documents and fee through the portal to the concerned State Licensing Authority. CDSCO states that the authority may issue Form MD-42 within ten days from the application date where the submitted information is satisfactory.

MD 42 Registration Process

1. Confirm that the business is exclusively engaged in medical-device sale or distribution.
2. Identify the correct state jurisdiction.
3. Prepare the medical-device product list.
4. Establish suitable storage premises.
5. Collect entity and premises documents.
6. Create an applicant profile on the Medical Devices portal.
7. Select and complete Form MD-41.
8. Enter firm, premises and product details.
9. Upload supporting documents.
10. Pay the prescribed government fee.
11. Submit the online application.
12. Respond to deficiency notices or inspection requests.
13. Download the Form MD-42 Registration Certificate after approval.

Documents Required for MD 42 Registration

The final checklist can vary by state, product category and business structure. 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 agreement.
• No-objection certificate from premises owner.
• Site plan.
• Layout plan.
• Storage-area details.
• Refrigerator details, where applicable.
• Temperature-monitoring arrangements, where applicable.
• Medical-device product list.
• Manufacturer authorisation letter.
• Importer authorisation letter.
• Distributor authorisation letter.
• Responsible-person details.
• Storage and handling procedure.
• Complaint-handling procedure.
• Product-recall procedure.
• Purchase and distribution record procedure.
• Fee-payment receipt.

The applicant should ensure that the entity name, product list, supplier authorisation and premises details are consistent across all documents.

MD 42 Licence Product List

The MD 42 licence product list should clearly describe the medical devices that the business plans to stock, sell or distribute.

The list should generally include:

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

Examples of products that may appear in the product list include:

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

The applicant should not include products that it is not authorised to procure or distribute.

Medical Device Wholesale Licence Premises

A business applying for a medical device wholesale licence should maintain suitable premises for storage and distribution.

The premises should support:

• Safe storage.
• Clean and organised shelving.
• Product segregation.
• Temperature control, where applicable.
• Protection from moisture and damage.
• Segregation of damaged stock.
• Segregation of expired stock.
• Purchase-record maintenance.
• Distribution-record maintenance.
• Product traceability.
• Complaint handling.
• Product recall.

Temperature-sensitive devices, diagnostic kits or products with manufacturer-specified storage conditions should be maintained under appropriate environmental controls.

MD 42 Licence Registration in Uttar Pradesh

MD 42 Licence Registration in Uttar Pradesh may be relevant for businesses operating from premises located in:

• Noida.
• Greater Noida.
• Ghaziabad.
• Lucknow.
• Kanpur.
• Agra.
• Meerut.
• Varanasi.
• Prayagraj.
• Aligarh.
• Bareilly.
• Gorakhpur.
• Other Uttar Pradesh locations.

The applicant should apply to the relevant Uttar Pradesh State Licensing Authority and ensure that the actual storage or distribution premises are accurately declared.

MD 42 Licence Registration in Ghaziabad

A business seeking MD 42 Licence Registration in Ghaziabad should apply under Uttar Pradesh jurisdiction.

The Ghaziabad application should include accurate details for:

• Ghaziabad premises address.
• Rent agreement or ownership proof.
• Product-storage area.
• Manufacturer or importer authorisation.
• Medical-device product list.
• GST registration.
• PAN.
• Entity documents.
• Responsible person.
• Storage-condition controls.
• Record-maintenance procedure.

A business cannot use a virtual office or unrelated address when the actual devices are stored and distributed from another location.

MD 42 Validity and Retention Fee

The Form MD-42 Registration Certificate is valid in perpetuity, subject to payment of the prescribed retention fee before completion of each five-year period from the date of issue.

If the retention fee is not paid on time, late fees may apply. If payment is not completed within the prescribed additional period, the registration certificate can be deemed cancelled.

The certificate holder should maintain a compliance calendar for:

• Five-year retention-fee payment.
• Manufacturer authorisation renewals.
• Product-list updates.
• Premises changes.
• Responsible-person changes.
• Complaint and recall review.
• Stock and distribution record retention.

MD 42 Consultant

An MD 42 consultant can help medical-device wholesalers and distributors identify the correct state-specific application route and prepare a complete online filing.

Agile Regulatory can assist with:

• MD 42 registration.
• MD 42 licence assessment.
• Medical device wholesale licence planning.
• Form MD-41 application filing.
• MD 42 registration online support.
• MD 42 licence product-list preparation.
• Manufacturer authorisation review.
• Importer authorisation review.
• Storage-premises compliance assessment.
• MD 42 registration in Uttar Pradesh.
• MD 42 registration in Ghaziabad.
• CDSCO MD 42 documentation support.
• Deficiency-response support.
• Retention-fee planning.
• Post-registration compliance support.

Common MD 42 Registration Mistakes

Businesses should avoid:

• Applying in the wrong state.
• Declaring a virtual address instead of the actual storage premises.
• Treating MD-42 as an import licence.
• Treating MD-42 as a manufacturing licence.
• Filing without a complete product list.
• Using incomplete manufacturer authorisation.
• Storing products without suitable conditions.
• Failing to maintain purchase records.
• Failing to maintain sale and distribution records.
• Not tracking batch, lot or expiry details where relevant.
• Not maintaining complaint and recall procedures.
• Missing the five-year retention-fee due date.
• Not updating changed premises or entity information.

Conclusion

MD 42 registration is an essential regulatory step for businesses exclusively involved in the sale, stock and distribution of medical devices. The applicant files Form MD-41 online with the concerned State Licensing Authority and receives the registration certificate in Form MD-42 after approval.

For businesses operating in Ghaziabad, Noida, Greater Noida or other Uttar Pradesh locations, the application should be made under Uttar Pradesh jurisdiction. Accurate product information, suitable storage conditions, valid manufacturer or importer authorisation and proper record-keeping are essential for successful medical-device wholesale compliance.

Frequently Asked Questions

1. What is MD 42 registration?

MD 42 registration is the process of obtaining a Registration Certificate in Form MD-42 for selling, stocking, exhibiting, offering for sale or distributing medical devices.

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

MD-42 is commonly called a medical device wholesale licence. 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 the required documents, paying the prescribed fee and submitting the application to the concerned State Licensing Authority.

4. Which authority issues MD-42 in Ghaziabad?

The relevant Uttar Pradesh State Licensing Authority issues MD-42 for medical-device premises located in Ghaziabad.

5. What is the validity of MD-42 certificate?

Form MD-42 is valid in perpetuity, subject to payment of the prescribed retention fee before completion of every five-year period from the date of issue.