Overview : CDSCO MD-42 License
An MD-42 License, formally known as a Form MD-42 Registration Certificate, is an authorisation for eligible businesses to sell, stock, exhibit, offer for sale or distribute medical devices, including in-vitro diagnostic (IVD) devices, in India. The application is made in Form MD-41 to the concerned State Licensing Authority under the Medical Devices Rules, 2017.
The MD-42 registration route was introduced in September 2022 as an alternative to the applicable drug-sale licensing framework for businesses dealing in medical devices. A business that already holds an appropriate licence under Rule 87 may not need a separate MD-42 certificate for the same covered activities.
Legal Papers India Business Solution Private Limited is a private business-registration and compliance consultancy. Businesses planning medical device distribution can contact the company to discuss their requirements, confirm the availability of MD-42 assistance and request a quotation.
Contact Legal Papers India to discuss your medical device business and registration requirements.
What Is an MD-42 Registration Certificate?
Form MD-42 is the registration certificate issued by the concerned State Licensing Authority to an eligible business for the sale, stocking, exhibition, offering for sale or distribution of medical devices, including IVD devices.
The legal basis is found in Rules 87A to 87D of the Medical Devices Rules, 2017, introduced through the Medical Devices (Fifth Amendment) Rules, 2022.
The registration is linked to the applicant and its declared premises. It requires suitable storage arrangements, eligible competent technical staff, lawful sourcing and prescribed records.
Although commonly called a CDSCO MD-42 License, the certificate is issued by the State Licensing Authority rather than CDSCO directly.
Who Needs an MD-42 License in India?
Businesses that sell or distribute regulated medical devices must have the applicable regulatory authorisation. The correct route depends on the business's existing licences and activities.
- Medical Device Wholesalers
A wholesaler purchasing medical devices for supply to retailers, hospitals or other eligible customers must determine whether it needs MD-42 registration or already holds a qualifying sale licence.
- Medical Device Retailers
A retailer selling regulated medical devices directly to customers must assess its applicable sale-authorisation requirements.
A retail business should not assume that an ordinary shop registration or GST registration is sufficient.
- Medical Device Distributors and Stockists
Businesses storing devices for onward distribution need appropriate premises, technical supervision and records.
The required registration or licence should cover the proposed activities.
- In-Vitro Diagnostic Device Suppliers
Businesses distributing regulated IVD products, including relevant diagnostic kits and reagents, fall within the medical-device sale and distribution framework.
The products' storage requirements and regulatory status must be considered.
Online Medical Device Sellers
Selling through a website or marketplace does not automatically remove the underlying medical-device sale-authorisation requirements. The applicant should determine which premises, stock-holding arrangements and other activities require authorisation.
Businesses Already Holding a Drug-Sale Licence
Rule 87 provides an alternative involving qualifying licences under Part VI of the Drugs and Cosmetics Rules, 1945. A business should first assess whether its existing licence already authorises the relevant medical-device activities.
It should not be advised to obtain a duplicate MD-42 certificate without reviewing its actual licensing position.
Is MD-42 Mandatory for Every Medical Device Seller?
No. MD-42 is an available registration route under the Medical Devices Rules, but it is not the only legally recognised sale-authorisation route.
Rule 87 applies relevant provisions of the Drugs and Cosmetics Rules, 1945 to medical-device sales and recognises qualifying drug-sale licences.
Rule 87(1A) provides for registration where a person does not hold the relevant licence and intends to sell medical devices exclusively.
When Should a Business Consider MD-42?
MD-42 may be appropriate where a business deals exclusively in medical devices and does not hold the qualifying sale licence contemplated under Rule 87.
When Might an Existing Drug-Sale Licence Be Relevant?
An existing retail or wholesale drug-sale licence may provide the applicable route for the medical-device activities covered by the licence and Rules.
The licence category, premises and proposed products should be reviewed before deciding whether additional registration is necessary.
What If the Business Sells Both Medicines and Medical Devices?
A business handling both medicines and medical devices must assess the relevant pharmaceutical sale-licence requirements as well as the medical-device rules.
MD-42 registration alone should not be treated as permission to sell pharmaceutical medicines.
Difference Between Form MD-41 and Form MD-42
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Particular
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Form MD-41
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Form MD-42
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Purpose
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Application for registration |
Registration certificate |
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Submitted or issued by
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Applicant submits to the State Licensing Authority
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State Licensing Authority issues
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Legal provision
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Rule 87A(2)
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Rule 87A(4)
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Stage
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Before registration |
After successful scrutiny |
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Role
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Requests authorisation |
Establishes the approved registration |
An MD-41 application acknowledgement is not the same as an issued MD-42 registration certificate.
Eligibility Requirements for MD-42 Registration
Rule 87A establishes the main application requirements.
- Eligible Business Entity
The applicant may be an eligible proprietorship, partnership, LLP, company, society, trust or another permitted entity.
The prescribed application records the business constitution and premises particulars.
- Suitable Business Premises
The applicant must establish ownership or lawful rental occupancy of the premises.
Adequate space and proper storage conditions must be available for the devices handled.
The Rules do not prescribe a universal 10-square-metre minimum specifically for every MD-42 registration. The adequacy of the premises must be assessed against the applicable requirements.
- Competent Technical Staff
The business must identify eligible competent technical staff responsible for directing and supervising medical-device sales.
- Good Distribution Compliance
The applicant must provide the prescribed self-certification concerning Good Distribution Compliance.
- Storage Undertaking
The applicant must undertake to comply with the storage requirements for the medical devices it intends to handle.
Who Is Eligible as Competent Technical Staff for MD-42?
Rule 87A(3) recognises three qualification routes for competent technical staff.
A person may qualify if they:
Hold a degree from a recognised university or institution; or
Are a registered pharmacist; or
Have passed the intermediate examination or an equivalent recognised examination and have one year of experience dealing with the sale of medical devices.
The applicant should provide appropriate evidence supporting the selected qualification route.
Is a Pharmacist Compulsory for MD-42?
No. A registered pharmacist is one recognised option, but the Rules also provide other qualification routes.
A business should not be told that only a pharmacist or science graduate can serve as competent technical staff. The selected person must fulfil the required supervisory responsibilities.
Documents Required for MD-42 License Registration
Form MD-41 must be accompanied by the information and documents prescribed under Rule 87A(3).
Business Documents
- Applicant or business details.
- Constitution of the business.
- Identification evidence of the applicant or firm as prescribed.
- Authorisation of the signatory, where applicable.
- Government fee payment details.
Premises Documents
- Proof of ownership or lawful rental occupancy.
- Full address of the premises proposed for registration.
- Supporting information concerning the premises and storage arrangements.
Competent Technical Staff Documents
- Name and details of the appointed competent person.
- Qualification certificate or registered-pharmacist evidence.
- Relevant experience evidence where eligibility depends on experience.
- Appointment or other supporting employment documents where required.
Compliance Documents
- Self-certificate of Good Distribution Compliance.
- Brief description of other activities conducted at the premises.
- Undertaking to comply with applicable storage requirements.
The State Licensing Authority may publish an operational checklist for its jurisdiction.
Additional documents should not be described as universally mandatory unless required by the operative Rules or the concerned authority.
How to Apply for an MD-42 License Online
The applicant must submit Form MD-41 through the route accepted by the concerned State Licensing Authority.
CDSCO's guidance describes online filing through the medical-device portal. Its October 2022 implementation notice also directed State authorities to accept hard-copy applications where necessary. The correct submission method should therefore be confirmed for the applicant's State or Union Territory.
Step 1: Review Existing Licences
Determine whether the business already holds a qualifying licence under Rule 87.
This prevents unnecessary duplicate applications.
Step 2: Confirm the Proposed Business Activities
Identify whether the business will undertake retail sale, wholesale distribution, stocking or another regulated activity.
Confirm that the products are regulated medical devices or IVDs.
Step 3: Prepare the Premises
Arrange adequate space and appropriate storage conditions.
Confirm that the premises address and occupation documents are accurate.
Step 4: Appoint Competent Technical Staff
Identify an eligible person under Rule 87A(3) and prepare the supporting qualification documents.
Step 5: Prepare Form MD-41
Complete the applicant, business constitution, premises and competent-person details.
Prepare the required self-certification and undertakings.
Step 6: Pay the Government Fee
Pay the prescribed fee using the payment process accepted by the authority.
Retain the payment acknowledgement.
Step 7: Submit the Application
File Form MD-41 with the concerned State Licensing Authority using its current accepted application channel.
Step 8: Respond to Regulatory Queries
The authority scrutinises the submitted documents and determines whether the statutory requirements are met.
Provide any required clarification or correction.
Step 9: Receive Form MD-42
If satisfied, the State Licensing Authority issues the registration certificate in Form MD-42.
The business should check the certificate details and comply with the registration conditions.
MD-42 License Government Fees in India
The Medical Devices (Fifth Amendment) Rules, 2022 inserted specific registration and retention fees into the Second Schedule.
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Fee type
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Amount under the reviewed Gazette
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MD-42 registration certificate fee
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₹3,000 |
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Five-year registration retention fee
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₹3,000
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The amounts above are statutory fees from the reviewed central notification. Applicants should confirm the current operative fee schedule and payment instructions before filing.
Are Professional Consultancy Fees Included?
No. Government registration fees and private professional charges are separate. Other possible costs may include premises preparation, storage equipment, document preparation and optional professional assistance.
Legal Papers India has not provided a verified MD-42 consultancy package price. Contact Legal Papers India to enquire about available assistance and request an itemised quotation.
How Long Does MD-42 Registration Take?
Rule 87A(4) provides for the State Licensing Authority to grant Form MD-42 or reject the application with recorded reasons within ten days from the date of application, after scrutiny and satisfaction of the prescribed requirements. This is the statutory decision framework, not a guaranteed total project duration.
Preparing premises, arranging competent staff, collecting documents and correcting deficiencies may require additional time. The actual filing channel and administrative process should be confirmed with the concerned authority.
Is Physical Inspection Mandatory Before MD-42 Approval?
Rule 87A primarily describes scrutiny of the application documents before the authority grants or rejects the certificate. It does not establish a universal mandatory pre-grant physical inspection for every MD-41 application.
However, Rule 87B provides for regulatory inspection of records and related oversight by Medical Device Officers.
Applicants should maintain compliant premises and records rather than assume that registration eliminates future inspection.
MD-42 License Validity and Five-Year Retention
Under Rule 87C, an MD-42 registration certificate remains valid in perpetuity unless suspended or cancelled, subject to the prescribed retention-fee requirements.
The certificate holder must pay the retention fee before completion of the relevant five-year period.
1. Does MD-42 Expire After Five Years?
Not automatically.
The legal framework uses continuing validity with periodic retention-fee obligations. The five-year payment requirement should not be described as an ordinary licence expiry followed by a mandatory fresh registration application.
2. What Happens if the Retention Fee Is Paid Late?
Rule 87C provides for a late fee of 2% of the retention fee for every month or part of a month during the permitted six-month late-payment period.
If the required payment is not made within that period, the registration certificate is deemed cancelled. Businesses should maintain a retention calendar and preserve evidence of payment.
Compliance Requirements After MD-42 Registration
Display the Registration Certificate
The MD-42 certificate must be displayed prominently at the premises where it is visible to the public.
Maintain Adequate Storage
The business must provide suitable space and proper storage conditions for the devices handled.
Maintain Temperature and Lighting
Storage conditions must meet the requirements of the relevant medical devices.
Products requiring controlled temperatures need appropriate arrangements.
Purchase From Permitted Sources
Medical devices must be purchased from eligible importers, licensed manufacturers or registered or licensed entities, as provided in Rule 87B.
Maintain Purchase and Sale Records
Records must show relevant device particulars, including names, quantities, manufacturer or importer information, batch or lot numbers and expiry dates where applicable.
Preserve Records for the Prescribed Period
The applicable registers and records must be retained for at least two years from the last entry.
Maintain Form MD-43 Inspection Book
The registration holder must maintain the prescribed inspection book to enable the Medical Device Officer to record observations.
Maintain Competent Technical Supervision
The business should ensure that the competent technical staff arrangement continues to satisfy the applicable requirements.
Can One MD-42 Certificate Cover Multiple Premises?
Form MD-41 requires the address of the premises proposed for registration, and Form MD-42 identifies the registered premises.
A business operating separate shops or warehouses should not assume that one certificate automatically covers all locations.
The applicant should confirm the registration requirements for each premises with the relevant State Licensing Authority.
Can MD-42 Be Used for Medical Device Import or Manufacturing?
No. MD-42 concerns sale, stocking, exhibition, offering for sale or distribution.
It does not replace the medical-device import licensing framework or the applicable manufacturing licences.
For example, commercial import of relevant regulated medical devices may require a Form MD-15 import licence through a separate application process.
The applicant should identify every activity the business intends to undertake.
MD-42 Application Rejection, Suspension and Appeal
If the Application Is Rejected
Rule 87A(5) provides for an appeal to the State Government within 45 days of receiving the rejection order.
The State Government may examine the matter and dispose of the appeal within the period specified by the Rule.
If an Existing Certificate Is Suspended or Cancelled
Rule 87D allows the State Licensing Authority to take action for contravention of applicable legal requirements, subject to the prescribed procedure and opportunity to respond.
The certificate holder may appeal a suspension or cancellation order to the State Government within the applicable 45-day period.
Can a Business Continue Operating After Cancellation?
A business should not assume that a cancelled registration continues to authorise regulated activity. Its lawful operating position depends on the applicable order and whether it holds another valid authorisation covering the activity.
Common MD-42 Registration Mistakes
1. Applying Without Checking Existing Licences
A business may already have an appropriate sale licence under Rule 87. Its current permissions should be reviewed before selecting MD-42.
2. Using Incorrect Competent-Person Criteria
The degree-holder, registered-pharmacist and intermediate-plus-experience routes should be assessed using the actual Rule 87A wording.
3. Incomplete Premises Evidence
The application requires proof of lawful ownership or rental occupancy.
4. Treating MD-42 as a Product Approval
MD-42 registers the relevant sale or distribution premises. It does not independently approve an unlicensed medical device for manufacture or import.
5. Assuming the Certificate Expires Every Five Years
The Rules provide continuing validity subject to retention payments and compliance.
6. Ignoring Post-Registration Records
Registration holders must maintain sourcing, purchase, sale and inspection records
MD-42 Registration Enquiries With Legal Papers India
Medical device retailers, distributors and stockists should assess their existing authorisations before applying for MD-42 registration. The relevant questions include the nature of the products, the activities conducted at the premises, competent technical staff, storage conditions and the applicable State Licensing Authority.
Legal Papers India Business Solution Private Limited is a private business-registration and compliance consultancy. You can contact the company to discuss your requirements, confirm whether MD-42 registration assistance is available and request a quotation.
Information to Prepare Before Enquiring
- State or Union Territory of the business premises.
- Type of medical devices or IVD products handled.
- Retail, wholesale or distribution activity.
- Details of existing drug-sale or medical-device authorisations.
- Business structure.
- Premises ownership or rental status.
- Competent technical staff qualification route.
- Whether the enquiry concerns a new registration or an existing certificate.
The competent State Licensing Authority makes the registration decision.
Frequently Asked Questions
1. What is an MD-42 License?
An MD-42 License is formally a registration certificate for eligible businesses selling, stocking, exhibiting, offering for sale or distributing medical devices, including IVD devices. It is issued by the concerned State Licensing Authority under Rule 87A of the Medical Devices Rules, 2017 following an application in Form MD-41.
2. Is MD-42 issued by CDSCO?
No. Although the certificate is commonly called a CDSCO MD-42 License, the concerned State Licensing Authority issues it. CDSCO is the central regulator associated with the broader medical-device regulatory framework. Applicants should submit Form MD-41 through the process accepted by the authority responsible for their premises.
3. What is the difference between MD-41 and MD-42?
Form MD-41 is the application for registration of a medical-device sale or distribution business. Form MD-42 is the registration certificate issued after the authority is satisfied that the requirements have been met. Submitting an MD-41 application does not itself establish that the business has been registered.
4. Is MD-42 compulsory for all medical device wholesalers?
Not necessarily. Rule 87 recognises a qualifying drug-sale licence route, while Rule 87A provides for MD-42 registration. A wholesaler should first review its existing licences and proposed activities. A business dealing exclusively in medical devices without the relevant existing sale licence generally needs the appropriate MD-42 registration.
5. Is a pharmacist mandatory for MD-42?
No. Rule 87A recognises a registered pharmacist as one eligibility route, but it also recognises a degree from a recognised university or institution, or the prescribed intermediate qualification with one year of experience in medical-device sales. The appointed person must provide the required supervision.
6. What is the government fee for MD-42 registration?
The Medical Devices (Fifth Amendment) Rules, 2022 prescribe ₹3,000 for the registration certificate under the Second Schedule. The same reviewed schedule specifies ₹3,000 as the retention fee. Applicants should verify the operative fee schedule and current payment procedure with the concerned authority before filing.
7. What documents are required for MD-42?
Rule 87A requires applicant and business-constitution details, identification evidence, premises ownership or rental proof, competent technical staff information, Good Distribution Compliance self-certification, details of other premises activities and a storage-compliance undertaking. The applicable State Licensing Authority may also publish operational filing instructions.
8. How long does MD-42 approval take?
Rule 87A provides a ten-day framework for the State Licensing Authority to grant or reject a compliant application after scrutiny. The total time needed to prepare premises, collect documents and address deficiencies can be longer. No private consultant can guarantee the authority's approval or decision date.
9. Is an MD-42 License valid for five years?
MD-42 registration has continuing validity under Rule 87C unless suspended or cancelled, subject to payment of the prescribed retention fee before completion of each relevant five-year period. This is different from an automatic five-year expiry requiring a completely fresh registration application.
10. What happens if the MD-42 retention fee is late?
Rule 87C provides for a late fee of 2% of the retention fee per month or part of a month during the permitted six-month period. If the required payment is not made within that period, the registration is deemed cancelled. Businesses should monitor payment deadlines carefully.
11. Is a physical inspection compulsory for MD-42?
The registration provision does not establish a universal mandatory physical inspection before every approval. However, the Rules provide for regulatory inspection and examination of records by Medical Device Officers. Applicants must maintain compliant premises, storage arrangements and records even where registration is granted through document scrutiny.
12. Can an MD-42 holder sell IVD devices?
Yes, the MD-42 framework expressly covers medical devices including in-vitro diagnostic medical devices. The business must still comply with the applicable product, sourcing, storage and recordkeeping requirements. MD-42 does not replace any separate product-level regulatory permission required for the devices being supplied.
13. Can one MD-42 registration cover multiple shops?
The registration application and certificate identify the business premises. A business operating separate shops or warehouses should assess each location with the concerned State Licensing Authority rather than assume that one certificate automatically covers every premises. The exact requirements depend on the operational arrangement.
14. Can an MD-42 holder import medical devices?
MD-42 concerns the sale and distribution of medical devices. It does not independently authorise commercial import. An importer must assess the separate import-licensing requirements, including Form MD-14 and Form MD-15 where applicable, along with customs and other regulatory obligations.
15. What records must an MD-42 holder maintain?
The registration holder must maintain purchase and sale records containing the relevant device, quantity, supplier, batch or lot and expiry information. The applicable registers and records must be preserved for at least two years from the last entry. Form MD-43 is the prescribed inspection book.
16. What happens if an MD-42 application is rejected?
Rule 87A requires the authority to record reasons for rejection. An aggrieved applicant may appeal to the State Government within 45 days of receiving the rejection order. The applicant should review the identified deficiencies and determine whether an appeal or corrected application is appropriate.
17. Can I apply for MD-42 without a consultant?
Yes. An eligible applicant may submit Form MD-41 directly through the procedure accepted by the concerned State Licensing Authority. Professional consultancy is optional. The applicant remains responsible for accurate documents and ongoing compliance, and the government authority independently decides the application.
Discuss Your MD-42 Registration Requirements
Planning to sell, stock or distribute medical devices or IVD products in India?
Before applying, confirm whether an existing licence already covers your activities, whether MD-42 registration is required, and whether the premises, competent technical staff and documents meet the applicable conditions.
Legal Papers India Business Solution Private Limited can receive your enquiry and confirm the availability of private MD-42 registration assistance.
Contact Legal Papers India to discuss your requirements and request a quotation.
Disclaimer: Legal Papers India is a private consultancy, not CDSCO or a State Licensing Authority. Registration decisions are made by the competent government authority.
Official regulatory references
CDSCO – Medical Device Application Portal
