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.
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MD-41 | Application for registration | gold
MD-42 | Registration certificate granted | orange
State Licensing Authority | Grants the registration | blue
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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:
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MD-41 application | The applicant applies for registration.
Document scrutiny | The authority scrutinises the submitted documents.
Compliance review | Premises, competent person and distribution compliance are reviewed.
MD-42 certificate | The registration certificate is granted.
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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.
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Compliant Distribution | Supports compliant medical device distribution. | check
Formal Registration | Provides a formal registration framework for the business. | file
Premises on Record | Helps establish the identity and premises of the distributor. | globe
Storage Standards | Requires appropriate storage arrangements and conditions. | shield
Competent Staff | Establishes requirements for competent technical staff. | users
Traceability | Helps maintain purchase and sales records and product traceability. | search
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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.
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We can check your premises, competent-person and documentation readiness before the MD-41 application is filed.
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MD-42 Sales & Distribution Registration Process
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Determine eligibility | Check whether the proposed sale, stocking or distribution activity needs MD-42 registration.
Prepare business details | Applicant, constitution, registered office, premises, ownership and nature of business.
Appoint competent technical staff | Appoint a competent person meeting the prescribed qualification or experience route.
Prepare Good Distribution Compliance | Establish storage, handling, inventory and record procedures.
Prepare the MD-41 application | Compile the application with the required information and documents.
Submit the application | File with the State Licensing Authority along with the prescribed fee.
Regulatory scrutiny | The authority reviews the information and supporting documents.
Address observations | Provide clarification or additional documents where required.
Grant of MD-42 | The registration certificate is granted once requirements are satisfied.
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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.
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- Company or firm details and constitution of the applicant
- PAN and identification documents
- Authorisation documents
- Contact and registered office details
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- Address of the premises
- Ownership documents, where applicable
- Rent or lease agreement, where applicable
- Occupancy evidence
- Premises photographs, where applicable
- Storage-area details
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The Medical Devices Rules specifically require documentary evidence regarding ownership or occupancy of the premises.
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- Name of the competent person
- Educational qualification and experience details
- Qualification certificates
- Experience certificate, where applicable
- Appointment or authorisation document
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- Good Distribution Compliance self-certificate
- Storage and distribution procedures
- Purchase and sales records
- Product traceability procedure
- Complaint handling procedure
- Recall procedure, where applicable
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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
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These records may be inspected by the applicable Medical Device Officer. Accurate records also support product traceability and regulatory compliance.
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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.
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10 days | Grant or rejection after scrutiny
Form MD-41 | Application form
Form MD-42 | Registration certificate
State Authority | Grants the certificate
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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 |
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MD-41 is the application, while MD-42 is the registration certificate.
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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.
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Eligibility Assessment | MD-42 eligibility and regulatory assessment for your business. | search
Application Preparation | MD-41 preparation and online filing assistance. | file
Premises Documentation | Premises and storage documentation support. | globe
Competent Person | Competent technical person documentation guidance. | users
Distribution Compliance | Good Distribution Compliance and record-keeping guidance. | shield
After Registration | Regulatory query support and post-registration compliance. | clock
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Frequently Asked Questions
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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.
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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.
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Share your business and premises details, and our team will guide you through MD-41 to MD-42.
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