MD 42 Registration Online: Documents, Fees and State-Wise Guide

This certificate is commonly searched as an “MD 42 license” or “MD 42 licence.” Formally, it is a registration certificate under the Medical Devices Rules, 2017.

What Is MD 42 Registration?

MD 42 registration applies to a trader or distributor that deals exclusively in the stock, sale and distribution of medical devices. CDSCO states that such a business needs a registration certificate in Form MD-42.

The registration covers medical devices, including in-vitro diagnostic medical devices. It does not itself authorise manufacturing or importing.

MD 42 License for Medical Device Wholesale

The phrase MD 42 license for Medical Device Wholesale refers to the registration used by wholesale distributors of medical devices.

The statutory scope is broader than wholesale. It includes selling, stocking, exhibiting, offering for sale and distributing medical devices.

A business holding an existing applicable licence under Rule 87(1) may not need a separate MD-42 registration. Therefore, review current licences before applying.

Who Issues the MD 42 Certificate?

The concerned State Licensing Authority grants Form MD-42.

CDSCO sets the regulatory framework, but it is not correct to describe every MD-42 certificate as requiring approval from CDSCO headquarters. The rules assign the application and grant decision to the State Licensing Authority.

Eligibility and Staff Requirements

The applicant must submit the details and documents required under Form MD-41.

The application must include:

• Applicant and firm details.

• Business constitution.

• Identity proof, such as Aadhaar or PAN.

• Premises ownership or occupancy evidence.

• Competent technical staff details.

• Self-certificate on distribution compliance.

• Description of other activities at the premises.

• Undertaking on storage requirements.

The competent technical person must meet one of the following routes:

• Degree from a recognised university or institution.

• Registration as a pharmacist.

• Intermediate or equivalent education, plus one year of experience in medical-device sales.

MD 42 License Documents Required

The following MD 42 license documents required should be prepared before applying:

• Form MD-41.

• PAN and identity proof.

• Business constitution documents.

• Premises ownership or rent agreement.

• Site plan and key plan.

• Competent technical staff’s qualifications.

• Experience certificate, where applicable.

• Appointment letter and biodata.

• Self-certificate on distribution compliance.

• Storage-compliance undertaking.

• Fee-payment receipt.

The live portal may request additional documents based on the applicant category and state requirements.

MD 42 Registration Process

Step 1: Confirm Applicability

First, confirm whether the business needs MD-42 registration.

A trader or distributor dealing exclusively in medical devices generally needs Form MD-42. However, Class A non-sterile and non-measuring devices are exempt from the sale requirements under Chapter XI. 1514

Step 2: Choose the State Authority

Next, select the State Licensing Authority for the premises where the business will operate.

The business location determines the jurisdiction—not the consultant’s office or customer location.

Step 3: Complete Form MD-41

Enter the applicant, premises, competent person and storage details accurately.

The application must be accompanied by the prescribed fee and required documents.

Step 4: Pay the Fee

Pay the prescribed government fee through the designated application route.

The registration certificate fee is ₹3,000. The retention fee is also ₹3,000.

Step 5: Scrutiny and Grant

The State Licensing Authority reviews the application and documents.

If satisfied, it grants Form MD-42 within ten days of the application. If not satisfied, it must record reasons and reject the application within the same period.

Step 6: Display the Certificate

After approval, display the certificate prominently at the premises where it is visible to the public.

MD 42 Registration Fees and Validity

If the retention fee is late, a late fee of 2% per month or part-month applies for up to six months. Non-payment within that period results in deemed cancellation.

MD 42 License Registration in Uttar Pradesh

For MD 42 License Registration in Uttar Pradesh, apply to the Uttar Pradesh State Licensing Authority.

Prepare the application for the actual Uttar Pradesh premises. Ensure that the address, occupancy proof and competent-person details match the application.

MD 42 License Delhi

For an MD 42 license Delhi, apply to the Delhi State Licensing Authority.

Prepare the Delhi premises address, rent or ownership documents and staff records. Do not use a Noida or Ghaziabad address in a Delhi application.

MD 42 License Registration in Ghaziabad

For MD 42 License Registration in Ghaziabad, use the Uttar Pradesh jurisdiction for the Ghaziabad premises.

Prepare the Ghaziabad address, rent or ownership documents and staff records. Do not use a Delhi or Noida address in the Ghaziabad application.

MD 42 License Registration in Noida

For MD 42 License Registration in Noida, apply under Uttar Pradesh’s jurisdiction.

Ensure that the Noida premises has adequate space and storage conditions. The certificate holder must maintain required temperature and lighting for the devices handled.

Compliance After Registration

The MD-42 holder must:

• Display the certificate at the premises.

• Provide adequate storage space.

• Maintain required temperature and lighting.

• Purchase devices only from permitted importers, manufacturers or registered or licensed entities.

• Maintain purchase and sales records.

• Preserve records for at least two years from the last entry.

• Maintain an inspection book in Form MD-43.

Common Mistakes to Avoid

• Calling MD-42 a drug licence.

• Applying for the wrong state jurisdiction.

• Using a premises without adequate storage.

• Deploying a competent person without valid qualification proof.

• Ignoring the ten-day scrutiny timeline.

• Missing the five-year retention-fee payment.

• Assuming MD-42 permits import or manufacturing.

Conclusion

MD 42 registration online is essential for businesses exclusively selling, stocking or distributing medical devices. The applicant submits Form MD-41 to the State Licensing Authority, which may issue Form MD-42 within ten days if the application is satisfactory.

The registration fee is ₹3,000, and the certificate remains valid in perpetuity subject to the five-year retention fee.

Frequently Asked Questions

Is MD 42 a drug licence?

No. MD-42 is a medical-device registration certificate under the Medical Devices Rules, 2017.

Is a pharmacist compulsory?

Not always. The applicant may use a qualified degree-holder or a person with intermediate education and one year of medical-device sales experience.

Does MD-42 expire after five years?

No. It remains valid in perpetuity, subject to payment of the retention fee every five years and no suspension or cancellation.

Is MD-42 required for all Class A devices?

No. Class A non-sterile and non-measuring medical devices are exempt from the sale requirements under Chapter XI.