An MD 42 licence is commonly used to describe the medical-device registration certificate issued in Form MD-42. It is relevant for businesses engaged exclusively in the sale, stocking, exhibition, offer for sale or distribution of medical devices and in vitro diagnostic medical devices in India.
The applicant applies in Form MD-41 to the concerned State Licensing Authority. The certificate is governed by the Medical Devices Rules, 2017.
What Is MD 42 Registration?
MD 42 registration is a State Licensing Authority registration for a business dealing exclusively in medical-device sale and distribution activities.
The certificate may permit an eligible business to:
- Stock medical devices.
- Sell medical devices.
- Exhibit medical devices for sale.
- 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 devices to healthcare institutions.
CDSCO clarifies that a trader or distributor exclusively engaged in stock, sale and distribution of medical devices must obtain a registration certificate in Form MD-42.
MD 42 Certificate
The MD 42 certificate is issued after successful submission and review of the Form MD-41 application.
It should accurately state:
- Legal name of the firm.
- Registered premises address.
- Certificate number.
- State Licensing Authority.
- Certificate conditions.
- Date of issue.
- Type of permitted activity.
- Name of the certificate holder.
The certificate holder should retain a copy at the registered premises and produce it during inspection, audit, buyer review or regulatory enquiry.
Is MD 42 a Medical Device Wholesale Licence?
An MD 42 licence is commonly called a medical device wholesale licence, but the formal regulatory description is a registration certificate in Form MD-42.
It is different from a manufacturing, import or drug-wholesale licence.
A firm importing medical devices may need an import licence or authorisation in addition to MD-42 registration for local distribution activities.
CDSCO MD 42 and State Licensing Authority
The term CDSCO MD 42 is widely used because CDSCO regulates India’s medical-device framework. However, the application in Form MD-41 is made to the concerned State Licensing Authority, which grants the MD-42 certificate.
The authority depends on the physical location of the distribution or storage premises.
A company should apply in the state where its actual storage, sale or distribution premises are located.
MD 42 Registration Online
The MD 42 registration online process is completed using the medical-device online system.
CDSCO’s Form MD-41 user manual identifies the online system as the route for applications related to sale, stock, exhibition, offer for sale and distribution of medical devices.
MD 42 Registration Process
- Assess whether the business is exclusively engaged in medical-device sale or distribution.
- Identify the state in which the physical premises are located.
- Prepare the medical-device product list.
- Arrange compliant storage facilities.
- Collect business, premises and product documents.
- Create the applicant profile on the medical-device portal.
- Select Form MD-41.
- Complete firm and premises details.
- Add the product and device-category information.
- Upload supporting records.
- Pay the prescribed government fee.
- Submit the application to the State Licensing Authority.
- Respond to deficiencies or document queries.
- Facilitate inspection, if required.
- Download the MD-42 registration certificate after approval.
Documents Required for MD 42 Licence
The documentation requirement can differ by state, business model and device category. Common records include:
- PAN card.
- GST registration certificate.
- Certificate of incorporation.
- Partnership deed.
- LLP agreement.
- Proprietorship declaration.
- Memorandum of Association.
- Articles of Association.
- Board resolution.
- Authorisation letter.
- Registered-office proof.
- Premises ownership proof.
- Rent agreement.
- Lease agreement.
- No-objection certificate from premises owner.
- Site layout plan.
- Storage-area details.
- Refrigerator details, where applicable.
- Temperature-monitoring arrangements, where applicable.
- Product list.
- Device-category details.
- Manufacturer authorisation letter.
- Importer authorisation letter.
- Distributor authorisation letter.
- Responsible-person details.
- Storage and handling procedure.
- Complaint-handling procedure.
- Recall procedure.
- Stock-record procedure.
- Purchase and distribution record procedure.
- Fee-payment receipt.
- Affidavit or declaration, where required.
The details in the product list, manufacturer authorisation, invoices and storage records should remain consistent.
MD 42 Licence Product List
An accurate MD 42 licence product list is important because it helps demonstrate the devices the firm 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 condition.
- Product licence or registration details, where applicable.
- Manufacturer or importer authorisation details.
Examples may include:
- Surgical gloves.
- Syringes.
- Thermometers.
- Blood-pressure monitors.
- Pulse oximeters.
- Nebulisers.
- Glucose-monitoring devices.
- Diagnostic kits.
- Catheters.
- Orthopaedic implants.
- Surgical instruments.
- Infusion pumps.
- Hospital beds.
- Wheelchairs.
- Patient-monitoring equipment.
- Laboratory IVD devices.
A firm should not include products that it is not authorised to supply or that require a separate compliance route.
MD 42 Licence Registration in Delhi NCR
MD 42 licence registration in Delhi NCR depends on the actual premises location, not merely the company’s marketing address.
For example:
- A distributor with a storage warehouse in Delhi applies under the Delhi jurisdiction.
- A distributor with a warehouse in Gurugram or Faridabad applies under Haryana jurisdiction.
- A distributor with premises in Noida, Greater Noida or Ghaziabad applies under Uttar Pradesh jurisdiction.
A business operating in multiple states may need separate state-level registrations for each physical distribution or storage location.
MD 42 Licence Registration in Haryana
A business seeking MD 42 licence registration in Haryana should apply to the Haryana State Licensing Authority where the device-storage or distribution premises are located.
This may be relevant for businesses operating in:
- Gurugram.
- Faridabad.
- Sonipat.
- Panipat.
- Karnal.
- Ambala.
- Hisar.
- Rohtak.
- Rewari.
- Bahadurgarh.
- Yamunanagar.
- Other Haryana locations.
The applicant should ensure that its Haryana premises have suitable storage arrangements and that the application reflects the actual product range and distribution activity.
MD 42 Licence Registration in Uttar Pradesh
A business seeking MD 42 licence registration in Uttar Pradesh should apply through the applicable Uttar Pradesh State Licensing Authority process.
This may be relevant for businesses operating in:
- Noida.
- Greater Noida.
- Ghaziabad.
- Lucknow.
- Kanpur.
- Agra.
- Meerut.
- Varanasi.
- Prayagraj.
- Aligarh.
- Bareilly.
- Gorakhpur.
- Other Uttar Pradesh locations.
The business should ensure that its Uttar Pradesh premises address, lease or ownership proof, product list, manufacturer authorisation and storage controls are complete before filing.
MD 42 Validity and Retention Fee
The MD-42 registration certificate is issued in perpetuity, subject to payment of the prescribed retention fee every five years from the date of issue.
The certificate may be suspended or cancelled if the holder fails to comply with the Medical Devices Rules, certificate conditions or applicable regulatory directions.
The holder should establish an internal compliance reminder for the five-year retention-fee deadline.
Post-Registration Compliance
After obtaining MD-42 registration, the certificate holder should maintain:
- Suitable storage conditions.
- Temperature control for sensitive devices, where applicable.
- Purchase records.
- Stock records.
- Distribution records.
- Customer or consignee records, where required.
- Supplier records.
- Complaint records.
- Product-recall procedures.
- Damaged-product procedures.
- Expired-product handling records.
- Product-traceability records.
- Manufacturer or importer authorisation.
- Updated product list.
- Valid certificate and retention-fee records.
MD 42 Licence Consultant
An MD 42 licence consultant can assist medical-device wholesalers and distributors with application readiness and state-specific filing.
Agile Regulatory can assist with:
- MD-42 applicability assessment.
- Medical device wholesale licence review.
- Form MD-41 application preparation.
- MD-42 registration online filing.
- Product-list preparation.
- Manufacturer-authorisation review.
- Importer-authorisation review.
- Storage-premises compliance assessment.
- Delhi NCR MD-42 registration.
- Haryana MD-42 registration.
- Uttar Pradesh MD-42 registration.
- CDSCO MD-42 documentation support.
- Deficiency response.
- Retention-fee planning.
- Post-registration compliance support.
Conclusion
An MD 42 licence is an essential registration certificate for businesses exclusively engaged in the sale, stock, exhibition, offer for sale or distribution of medical devices. The applicant submits Form MD-41 to the relevant State Licensing Authority and receives the certificate in Form MD-42 after successful review.
Businesses in Delhi NCR, Haryana and Uttar Pradesh should apply according to the location of their actual premises, maintain proper storage and distribution records, retain manufacturer or importer authorisation and track the five-year retention-fee requirement. Proper MD 42 registration helps a medical-device distributor build a compliant foundation for lawful operations.
Frequently Asked Questions
1. What is an MD 42 licence?
An MD-42 licence is commonly used to refer to the Form MD-42 registration certificate for sale, stock, exhibition, offer for sale and distribution of medical devices.
2. How do I apply for MD 42 registration online?
Apply through the medical-device online system by filing Form MD-41, uploading the prescribed documents, paying the applicable fee and submitting the application to the concerned State Licensing Authority.
3. Is MD-42 a wholesale licence for medical devices?
MD-42 is commonly called a medical device wholesale licence. Formally, it is a registration certificate for medical-device sale and distribution activity.
4. Is MD-42 valid for five years?
No. CDSCO states that the Form MD-42 registration certificate is issued in perpetuity, subject to payment of the applicable retention fee every five years, unless suspended or cancelled.
5. Which authority grants MD-42 in Delhi NCR?
The concerned State Licensing Authority grants MD-42 based on the location of the physical premises: Delhi for Delhi premises, Haryana for Gurugram or Faridabad premises, and Uttar Pradesh for Noida, Greater Noida or Ghaziabad premises.
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