If your business sells, stocks, distributes, or exhibits medical devices in India — whether you are a wholesaler, retailer, distributor, online seller, or stockist — you legally cannot operate without a valid medical device distribution license (form MD-42).
This is not a voluntary registration or a best-practice recommendation. Under Rule 68 of the Medical Device Rules, 2017, no person shall sell, stock, exhibit, or offer for sale or distribute any notified medical device without a valid MD-42 certificate. State Drug Controllers across Maharashtra, Delhi, Karnataka, Uttar Pradesh, and other major states have been actively enforcing this rule since 2025 — with stock seizures, listing suspensions on Amazon and Flipkart, and legal notices being issued to non-compliant businesses.
ELT Corporate handles the complete MD-42 registration process for businesses across India — from Form MD-41 preparation and SUGAM portal submission to State Licensing Authority inspection preparation and certificate delivery.
Amazon, Flipkart, and other major e-commerce platforms now mandatorily require businesses to upload a valid MD-42 Registration Certificate before listing notified medical devices like glucometers, BP monitors, pulse oximeters, nebulisers, and surgical instruments. Without it, your listings will be suspended.
The MD-42 Registration Certificate is the official legal permit issued by the State Licensing Authority (SLA) — operating under the Ministry of Health and Family Welfare — that authorises a business to sell, stock, exhibit, offer for sale, or distribute medical devices in India.
It is a state-specific license, which means:
The certificate is issued in response to Form MD-41 — the application form filed by the business. The Form MD-41 is applied for, and upon approval, the SLA grants the MD-42 certificate. This is why the process is commonly referred to as MD-41/MD-42 registration.
The MD-42 license is valid in perpetuity — it does not expire annually. However, a retention fee is payable every 5 years to keep it active. Missing this payment results in automatic lapse of the license.
Any business entity that deals in notified medical devices in India — at any stage after manufacture or import — must hold an MD-42 Registration Certificate. This covers a wide range of businesses:
MD-42 is required for all medical devices notified under the Medical Device Rules, 2017. As of 2026, CDSCO has notified the following major device categories — and the list continues to expand through gazette notifications:
Always verify your specific device’s current notification status on the CDSCO website before finalising your application. CDSCO periodically adds new device categories through gazette notifications. Your consultant can confirm current notification status for your product lines.
Any legally registered business entity in India can apply for an MD-42 Registration Certificate — including sole proprietorships, partnership firms, LLPs, and private limited companies. However, two core eligibility requirements must be met:
1. Qualified Technical Supervision
This is the most important eligibility requirement — and the one most commonly overlooked. The business must have a qualified person supervising its medical device operations. State Licensing Authority (SLA):
• A registered pharmacist (B.Pharm / M.Pharm) with a valid pharmacy council registration — this is the most commonly accepted qualification
• A graduate in Science with at least one year of experience in dealing with medical devices
This qualified person must be physically present at the licensed premises during business hours. You cannot appoint a part-time or remote supervisor for the purpose of MD-42 compliance. If you do not have a qualified person in-house, you will need to hire one before applying.
2. Adequate Licensed Premises
The business premises must comply with Good Distribution Practice (GDP) standards for medical devices. This includes:
• Adequate storage space appropriate for the devices being handled — clean, organised, and accessible
• Temperature control as required by specific device categories (e.g., certain IVD reagents or biologics require cold chain storage)
• Proper lighting, ventilation, and protection from moisture and contamination
• Separate areas for incoming goods, quarantine (if required), and outgoing dispatch
• Traceability records for all devices purchased and sold — batch numbers, supplier details, buyer details
The MD-42 registration process is managed at the state level — filed through either the CDSCO SUGAM portal or the state’s own licensing portal (certain states like Uttar Pradesh use Nivesh Mitra; others process offline through the State FDA office). Here is the standard process:
Typical approval timeline: 30 to 45 days from complete application submission. The most common causes of delay are: incomplete documents at submission, inconsistencies between Form MD-41 and supporting documents, and inadequate premises during inspection. ELT Corporate’s preparation eliminates all three.
Receiving the MD-42 certificate is the beginning of an ongoing compliance responsibility. Non-compliance with post-approval obligations can result in suspension or cancellation of your certificate — and resumption of stock seizure risk:
This is the most common rejection reason. If you do not have a registered pharmacist or science graduate with device experience already employed and on-site before you apply, your application will be rejected during the premises inspection. Hire your qualified person first — then apply.
If the entity name on your GST certificate does not exactly match the name in Form MD-41, or if the premises address on your rental agreement differs slightly from what you entered in the form, the SLA will raise a query. Every field must be consistent across every document.
The Drug Inspector visits your premises and expects to see functional, GDP-compliant storage arrangements — not a half-setup warehouse. Temperature control equipment must be functional, storage areas must be labeled and organised, and records must already be in place. A premises that is not ready at the time of inspection results in rejection and a re-inspection request.
Many applicants list only their current product lines in Form MD-41 and then try to add new categories later. This requires a fresh amended certificate application. List all device categories you realistically expect to handle — within your business scope — at the time of initial application.
A drug wholesale or retail license does NOT cover medical devices under MDR 2017. Businesses that have been relying on their existing drug license for medical device distribution are now being targeted by SLA enforcement teams. Get a separate MD-42 before enforcement action reaches your business.
ELT Corporate has helped thousands of distributors, wholesalers, retailers, and online sellers obtain their MD-42 Registration Certificates across all major states in India. Our MD-42 service covers every step — from the initial eligibility assessment to certificate delivery:
ELT Corporate has extensive experience in handling MD-42 licensing across multiple states in India — medicaldeviceregistration.com. Our track record of 2,500+ successful registrations speaks for itself.
You must inform the State Licensing Authority within 45 days and apply for a new license within 180 days. Your existing license remains valid until the new one is granted or rejected.
Yes. MD-42 is premises-specific. Each location from which you sell, stock, or distribute medical devices requires its own separate certificate from the respective State Licensing Authority. If you operate a warehouse in Delhi and a sales office in Mumbai, you need two MD-42 certificates.
Typically 30 to 45 days from complete application submission. The timeline depends on how quickly the SLA processes applications in your state, the completeness of your documentation, and the outcome of the premises inspection. ELT Corporate’s thorough preparation consistently achieves approval at the shorter end of this range.
No. The qualified technical person must be physically present at the licensed premises during business hours. Part-time arrangements, remote supervision, or paper-only appointments are not accepted by the SLA. This person must be a genuine, verifiable employee of the business.
Yes, in some cases a drug wholesale or retail license is used by businesses to handle certain medical devices, especially low-risk or non-notified products.
However, for notified medical devices regulated under the Medical Device Rules, 2017, a separate Medical Device Distribution License (Form MD-42) is generally required. Regulatory authorities are increasingly enforcing this requirement.
It typically takes 3 to 6 months from application to approval.
