MD-42 Sales & Distribution Licence for Medical Devices

The MD-42 Sales & Distribution Licence is the registration certificate for businesses that intend to sell, stock, exhibit, offer for sale or distribute medical devices, including in-vitro diagnostic (IVD) medical devices, in India.

Under the Medical Devices Rules, 2017, an eligible person applies in Form MD-41 to the State Licensing Authority (SLA). After the prescribed documents and requirements are reviewed, the registration certificate is granted in Form MD-42.

CDSCO also states that where a trader or distributor is exclusively involved in the stock, sale and distribution of medical devices, the applicable registration is Form MD-42 rather than the wholesale drug licence route.

• MD-41Application for registration
• MD-42Registration certificate granted
• State Licensing AuthorityGrants the registration

Quick Facts

Particular	Details
Application form	Form MD-41
Certificate form	Form MD-42
Issuing authority	State Licensing Authority
Regulatory framework	Medical Devices Rules, 2017
Covers	Sale, stock, exhibition, offer for sale, distribution
Includes	IVD medical devices
Key requirement	Competent technical staff
Timeline	10 days from application after scrutiny
Compliance	Good Distribution Compliance and records

What is an MD-42 Registration Certificate?

MD-42 is the registration certificate for selling, stocking, exhibiting, offering for sale or distributing medical devices, including IVD medical devices, under the Medical Devices Rules.

The applicant first submits an application in Form MD-41 to the State Licensing Authority. After scrutiny of the application and satisfaction that the prescribed requirements have been fulfilled, the certificate is granted in Form MD-42.

The registration process may involve information relating to:

• Applicant details and business constitution
• Registered and premises address
• Ownership or occupancy of premises
• Competent technical staff
• Medical device activities and storage arrangements
• Good Distribution Compliance
• Purchase and sales records
• Device details and applicable declarations

Who Needs an MD-42 Registration?

MD-42 registration may be relevant to businesses involved in:

• Sale, stocking and distribution of medical devices
• Offering or exhibiting medical devices for sale
• Wholesale distribution of medical devices
• Distribution of IVD medical devices
• Medical device trading activities

The exact requirement should be assessed according to the nature of the business, the products and the applicable exemptions.

Who Issues the MD-42 Registration Certificate?

The State Licensing Authority is responsible for granting the registration certificate. The basic regulatory pathway is:

1. MD-41 applicationThe applicant applies for registration.
2. Document scrutinyThe authority scrutinises the submitted documents.
3. Compliance reviewPremises, competent person and distribution compliance are reviewed.
4. MD-42 certificateThe registration certificate is granted.

Why is MD-42 Registration Required?

MD-42 registration provides a regulatory framework for businesses engaged in the sale, stocking and distribution of applicable medical devices.

• Compliant DistributionSupports compliant medical device distribution.
• Formal RegistrationProvides a formal registration framework for the business.
• Premises on RecordHelps establish the identity and premises of the distributor.
• Storage StandardsRequires appropriate storage arrangements and conditions.
• Competent StaffEstablishes requirements for competent technical staff.
• TraceabilityHelps maintain purchase and sales records and product traceability.

Registered businesses must continue following the applicable conditions and maintain appropriate records after receiving the certificate.

Who Can Apply for MD-42 Registration?

The MD-42 registration process may be relevant to:

• Medical device distributors, dealers and wholesalers
• Medical device stockists and sellers
• Medical device trading and supply businesses
• IVD distributors
• Businesses supplying medical devices to hospitals and healthcare institutions

The applicant must satisfy the applicable requirements relating to premises, competent technical staff, storage and distribution practices.

MD-42 Sales & Distribution Registration Process

1. Determine eligibilityCheck whether the proposed sale, stocking or distribution activity needs MD-42 registration.
2. Prepare business detailsApplicant, constitution, registered office, premises, ownership and nature of business.
3. Appoint competent technical staffAppoint a competent person meeting the prescribed qualification or experience route.
4. Prepare Good Distribution ComplianceEstablish storage, handling, inventory and record procedures.
5. Prepare the MD-41 applicationCompile the application with the required information and documents.
6. Submit the applicationFile with the State Licensing Authority along with the prescribed fee.
7. Regulatory scrutinyThe authority reviews the information and supporting documents.
8. Address observationsProvide clarification or additional documents where required.
9. Grant of MD-42The registration certificate is granted once requirements are satisfied.

The rules specify that the State Licensing Authority is to grant or reject the application, with reasons recorded in case of rejection, within ten days from the application date after scrutiny and satisfaction of the requirements.

Documents Required for MD-42 Registration

The exact documents may depend on the applicant, premises and nature of the distribution business.

The Medical Devices Rules specifically require documentary evidence regarding ownership or occupancy of the premises.

Competent Technical Staff for MD-42

The applicant must appoint a competent technical person under whose direction and supervision the medical device sales activity is undertaken. The rules provide specified qualification and experience routes, including:

• A degree from a recognised university or institution; or
• Registration as a pharmacist; or
• Intermediate examination or equivalent qualification with one year of experience in dealing with the sale of medical devices.

The appropriate route should be assessed according to the applicable regulatory requirements.

Good Distribution Compliance for Medical Devices

Good Distribution Compliance is an important part of the medical device distribution process. Important areas may include:

• Proper storage conditions, temperature and lighting requirements
• Inventory management and product identification
• Batch or lot traceability and expiry-date monitoring
• Purchase and sales records
• Complaint handling and product recall procedures

The rules require the registration certificate holder to provide adequate storage space and maintain the required temperature and lighting conditions for the medical devices.

Storage Requirements for Medical Devices

Appropriate storage is an important responsibility of an MD-42 registration holder. The premises should provide:

• Adequate storage space and suitable environmental conditions
• Appropriate temperature controls, where required
• Appropriate lighting
• Protection from contamination or damage
• Proper product segregation, where applicable
• Inventory identification and expiry-date monitoring

Purchase and Sales Records

An MD-42 registration holder should maintain records relating to the purchase and sale of medical devices, showing information such as:

• Names of medical devices
• Quantities purchased and sold
• Manufacturer or importer details
• Batch number or lot number
• Expiry date, where applicable

MD-42 Registration for Medical Device Distributors

Distributors move products from manufacturers or importers to hospitals, healthcare businesses and other permitted buyers. An MD-42 registration helps establish a structured compliance framework for sourcing, storage, inventory management, distribution, sales documentation, traceability, complaint handling and regulatory records.

The rules specify that registered entities should purchase medical devices only from an importer, licensed manufacturer or registered or licensed entity, as applicable.

MD-42 Registration for IVD Distribution

The MD-42 framework also covers applicable in-vitro diagnostic medical devices. Businesses selling, stocking or distributing eligible IVDs should assess their registration and compliance requirements under the Medical Devices Rules — the Form MD-42 certificate expressly covers medical devices including IVD medical devices.

MD-42 Registration Timeline

The regulatory timeline can depend on the completeness of the application, correctness of documents, premises and competent-person documentation, Good Distribution Compliance, regulatory observations and the applicant’s response.

• 10 daysGrant or rejection after scrutiny
• Form MD-41Application form
• Form MD-42Registration certificate
• State AuthorityGrants the certificate

Under the applicable rule, the State Licensing Authority is required to grant or reject the registration certificate within ten days from the application after scrutiny and satisfaction of the prescribed requirements. Applicants should still ensure that all documents are properly prepared before submission.

Government Fee for MD-42 Registration

The applicable government fee is prescribed under the relevant provisions and fee schedule of the Medical Devices Rules, 2017. Verify the current fee before submitting Form MD-41 rather than relying on an outdated amount.

Conditions After Obtaining MD-42 Registration

After obtaining the certificate, the holder must continue complying with the applicable requirements:

• Displaying the registration certificate at the premises
• Maintaining suitable storage conditions, temperature and lighting
• Purchasing medical devices from appropriate authorised sources
• Maintaining purchase and sales records
• Maintaining product traceability
• Cooperating with regulatory inspection
• Following applicable distribution requirements

MD-41 vs MD-42

MD-41	MD-42
Application form	Registration certificate
Used to apply for sales or distribution registration	Issued after applicable requirements are fulfilled
Submitted by the applicant	Granted by the State Licensing Authority
Application stage	Registration stage

MD-41 is the application, while MD-42 is the registration certificate.

— In simple words

MD-42 vs Wholesale Drug Licence

MD-42	Wholesale Drug Licence
Applies to medical device sales and distribution	Governed under the drug regulatory framework
Issued under the Medical Devices Rules	Issued under applicable drug rules
Covers applicable medical device activities	Primarily relates to drugs
Applied through the medical device process	Applied under drug licensing provisions

For businesses dealing exclusively in the stock, sale and distribution of medical devices, CDSCO’s FAQ states that the applicable registration certificate is Form MD-42.

Why Choose ELT Corporate for MD-42 Registration?

ELT Corporate helps medical device sellers, distributors and stockists navigate the MD-42 registration process.

• Eligibility AssessmentMD-42 eligibility and regulatory assessment for your business.
• Application PreparationMD-41 preparation and online filing assistance.
• Premises DocumentationPremises and storage documentation support.
• Competent PersonCompetent technical person documentation guidance.
• Distribution ComplianceGood Distribution Compliance and record-keeping guidance.
• After RegistrationRegulatory query support and post-registration compliance.

Frequently Asked Questions

• What is an MD-42 Registration Certificate?

  MD-42 is the registration certificate for eligible businesses that sell, stock, exhibit, offer for sale or distribute medical devices, including applicable IVD medical devices.

• Is MD-42 an application form?

  No. MD-41 is the application form, while MD-42 is the registration certificate issued after the applicable requirements are fulfilled.

• Who issues the MD-42 Registration Certificate?

  The State Licensing Authority grants the registration certificate under the applicable Medical Devices Rules.

• Who needs MD-42 registration?

  Eligible persons involved in selling, stocking, exhibiting, offering for sale or distributing applicable medical devices may require MD-42 registration.

• Is MD-42 required for medical device distributors?

  For businesses exclusively involved in stocking, selling and distributing medical devices, CDSCO’s FAQ states that registration in Form MD-42 is required.

• What documents are required for MD-42?

  Applicant details, constitution of the firm, premises ownership or occupancy documents, competent technical staff details, Good Distribution Compliance self-certificate and the required undertakings.

• Is a competent technical person required for MD-42?

  Yes. The application requires details of a competent person appointed to undertake the sales activity under the prescribed qualification or experience requirements.

• How long does MD-42 registration take?

  The applicable rule provides for grant or rejection within ten days from the application, after scrutiny and satisfaction of the prescribed requirements. Preparation time before filing can vary.

• Do MD-42 holders need to maintain sales records?

  Yes. The rules require records of purchases and sales, including quantities, manufacturer or importer details, batch or lot number and expiry date where applicable.

• Can ELT Corporate help with MD-42 registration?

  Yes. We assist with eligibility assessment, MD-41 preparation, documentation, competent-person requirements, Good Distribution Compliance, online filing and regulatory queries.

Need an MD-42 Sales & Distribution Licence?

If you are planning to sell, stock or distribute medical devices in India, ELT Corporate can assist with the MD-41 application, documentation, Good Distribution Compliance, competent-person requirements, regulatory filing and the MD-42 registration process.