INTRODUCTION

The medical device sector in India is witnessing rapid growth, and with it, the government has tightened compliance measures to ensure safety, accountability, and transparency. Among the most important requirements for businesses engaged in distribution, stocking, wholesale, or retail of medical devices is the MD-42 license, also known as the Medical Device Registration Certificate (Form MD-42).

This license, mandated under the Medical Devices Rules, 2017 (as amended), is issued by the State Licensing Authority and is essential for anyone handling medical devices, including in-vitro diagnostics. It ensures that medical devices are stored under proper conditions, records are meticulously maintained, and only authorized entities engage in their distribution.

The MD-42 license process involves submitting Form MD-41 through the CDSCO’s SUGAM portal, attaching required documents such as premises proof, technical staff details, undertakings for compliance, and paying the prescribed fee. Depending on the state, approval generally takes 2–4 weeks, though official timelines are around 10 days.

Operating without an MD-42 certificate can invite strict penalties, including seizure of stock, fines, and suspension of operations. At Lawfinity, we simplify the entire process—from document preparation to inspection readiness—ensuring your compliance is seamless and stress-free.

WHY IS THE MD-42 LICENSE REQUIRED?

Medical devices are not ordinary products—they directly affect human lives. Poor storage conditions, counterfeit supplies, or mismanaged distribution channels can compromise safety and effectiveness. To prevent such risks, the government mandates an MD-42 license for anyone engaged in the sale, stock, exhibit, or distribution of medical devices.

The license ensures:

Proper storage conditions (temperature, humidity, lighting).
Full traceability of sales and purchases, including manufacturer details and expiry dates.
Regulatory oversight by Medical Device Officers, who can inspect premises, check records, and collect samples.
A higher degree of accountability and transparency, protecting both patients and businesses.

In short, the MD-42 certificate is not just a piece of paper—it is a safeguard for quality, compliance, and trust.

WHO ISSUES THE MD-42 LICENSE?

The State Licensing Authority (SLA) of the respective state issues the MD-42 certificate. While the Central Drugs Standard Control Organisation (CDSCO) is the apex authority for medical device regulation in India, the SLA handles distribution-related licensing like MD-42.

The process begins with an application in Form MD-41, and once approved, the SLA issues the MD-42 registration certificate to the applicant.

ELIGIBILITY AND DOCUMENTS REQUIRED FOR MD-42 LICENSE

Eligibility Criteria

To apply for an MD-42 license in India, the applicant must be:

A retailer, wholesaler, stockist, distributor, or seller of medical devices (including in-vitro diagnostics).
Operating from a premise that complies with basic storage and handling norms.
Employing technically qualified staff to oversee operations, if required by the state authority.

Documents Required

Applicants must prepare and submit the following:

Form MD-41 application filled through the SUGAM portal.
Fee receipt of ₹3,000 (official license fee).
Identity proof of the applicant (PAN, Aadhaar, etc.).
Ownership/lease documents of the premises (rent agreement or property papers).
Details of technical staff with qualification and experience certificates.
Self-declaration confirming compliance with Good Distribution Practices.
Undertaking for proper storage and record-keeping norms.
Inspection book (Form MD-43) maintained at the premises.

Additionally, businesses must maintain proper records of sales and purchases, including details such as batch number, manufacturer, expiry date, and invoice numbers, preserved for at least two years.

HOW TO APPLY FOR MD-42 LICENSE IN INDIA

The MD-42 license process involves several digital and manual steps. Here’s a simplified walkthrough:

Prepare Documentation

Collect all documents, including ID proof, premises proof, technical staff details, and undertakings for compliance.

Register on the SUGAM Portal

The CDSCO’s SUGAM portal is the online platform where applications are submitted. Register your business entity and upload the required documents with the application form.

Submit Form MD-41

Fill out and submit Form MD-41 online, along with the ₹3,000 license fee payment.

Scrutiny by the SLA

The State Licensing Authority reviews your application for completeness and correctness.

Premises Inspection (if required)

A Medical Device Officer may visit your premises to verify storage facilities, staff qualifications, and compliance with norms.

Grant of MD-42 Certificate

Once approved, the SLA issues the MD-42 license, which must be displayed prominently at your business premises.

Post-Approval Compliance

Maintain accurate records of all sales and purchases.
Keep the inspection book (Form MD-43) updated.
Renew or retain your license as per rules.

MD-42 LICENSE APPROVAL TIME

The official approval timeline for an MD-42 license is approximately 10 working days from the date of a satisfactory application. However, depending on the workload of the State Licensing Authority and inspection scheduling, the process may take up to 3–4 weeks in practice.

PENALTIES FOR OPERATING WITHOUT MD-42 LICENSE

Conducting distribution or retail activities without a valid MD-42 certificate is a serious offense. Consequences include:

Seizure of stock by regulatory authorities.
Legal penalties, including fines and prosecution.
Suspension of business operations until compliance is achieved.
Loss of credibility with suppliers, customers, and online marketplaces (many e-commerce platforms insist on MD-42 compliance before onboarding sellers).

Simply put—running your operations without this license is a risk no business should take.

HOW LAWFINITY SIMPLIFIES THE MD-42 LICENSE PROCESS

At Lawfinity, we know that compliance procedures can often feel complex, time-consuming, and stressful. That’s why our approach to the MD-42 license is designed to be smooth, end-to-end, and client-friendly. Our goal is not just to help you obtain the certificate but to ensure that your business remains compliant, confident, and future-ready.

Expert Consultation

We begin by carefully analyzing your business activity to determine whether you fall under MD-42 licensing requirements. This saves you time, money, and unnecessary confusion.

Document Preparation

Preparing the correct paperwork is one of the biggest hurdles for applicants. Our team collects, drafts, and reviews all required documents—from premises proof to self-certifications—ensuring your application is error-free and ready for approval.

SUGAM Portal Assistance

Digital filing can be tricky, especially for first-time applicants. We handle everything on the CDSCO’s SUGAM portal, from creating your profile to submitting Form MD-41 with attachments and fee payments, ensuring a seamless online process.

Inspection Readiness

In case the State Licensing Authority conducts an inspection, we prepare you in advance. Our pre-inspection audits check your premises, record-keeping, and storage conditions so you face the regulator with confidence.

Timeline Tracking

We actively follow up with the State Licensing Authority, keeping you informed at every stage and minimizing unnecessary delays.

Retention and Renewal Support

Since the MD-42 license requires retention every five years, we provide timely reminders and full assistance to keep your certificate perpetually valid.

With Lawfinity, you don’t just hire a consultant—you gain a trusted compliance partner. We take the complexity out of the MD-42 license process so you can focus on growing your medical device business while we take care of the legalities.

MUSINGS FROM THE AUTHOR’S INK

Sometimes, compliance feels like a maze with no exit—endless forms, certificates, and digital portals that consume your energy and test your patience. It’s easy to view the MD-42 license as just another bureaucratic obstacle, but when you pause and look deeper, you realize it serves a far greater purpose.

Every requirement exists to ensure that the medical devices we use daily are safe, traceable, and reliable. The stethoscope in a doctor’s hand, the syringe in a hospital ward, or the diagnostic kit in a laboratory all pass through regulated systems that protect patients and build trust in healthcare. That’s why every tick mark, signature, and stamp matters—they carry the weight of accountability.

Yes, the paperwork may feel heavy, and yes, the process may stretch your patience. But behind it all lies a system designed to safeguard lives. Compliance is not just a rule—it’s a shield that protects businesses, patients, and communities alike.

At Lawfinity, we believe that no entrepreneur should feel alone in this process. With the right partner, even the most complex regulatory landscape becomes manageable, empowering you to focus on growth while staying fully compliant.