INTRODUCTION

The Indian healthcare and medical device sector has grown rapidly in the last decade, driven by innovation, affordability, and government reforms. However, with growth comes responsibility—particularly in ensuring that medical devices reaching hospitals, clinics, and patients are safe, reliable, and compliant.

This is where the MD-5 license comes into the picture. If you are a manufacturer of Class A or Class B medical devices, then obtaining an MD-5 license is not just a legal formality—it’s your ticket to enter the market with credibility.

In this blog, we break down the meaning of MD-5 license, who issues it, eligibility, documents required, the complete step-by-step application process, penalties for non-compliance, and how Lawfinity can guide you through every step.

WHY SUCH MD 5 LICENCE IS REQUIRED?

Medical devices are not like ordinary consumer goods. A faulty syringe, a malfunctioning blood pressure monitor, or a substandard stent can put lives at risk. To ensure public safety, India’s Central Drugs Standard Control Organization (CDSCO), under the Drugs and Cosmetics Act and the Medical Device Rules, 2017, has made it mandatory for manufacturers to obtain specific licenses based on device classification.

The MD-5 license is required for manufacturing Class A (low-risk) and Class B (low-moderate risk) medical devices. Without this approval, no manufacturer can legally produce or sell such devices in India.

In short, an MD-5 license ensures:

Quality compliance with ISO 13485 and Good Manufacturing Practices (GMP).
Patient safety by verifying manufacturing standards.
Market credibility by allowing legal sale and distribution.
Regulatory confidence for both domestic and export markets.

WHO ISSUES MD 5 LICENCE?

Licensing authority depends on the classification of the device:

Class A & B Medical Devices: License is granted by the State Licensing Authority (SLA), under the supervision of CDSCO.
Class C & D Medical Devices: Higher-risk devices are licensed directly by the Central Licensing Authority (CLA) at CDSCO headquarters.

Thus, the MD-5 license for Class A and B devices is issued by the SLA, after due inspection and evaluation of the manufacturing facility.

ELIGIBILITY AND DOCUMENTS REQUIRED FOR MD-5 LICENCE

Eligibility Criteria

Applicant must be an Indian manufacturer of Class A or B medical devices.
The manufacturing site should comply with ISO 13485 standards.
A qualified competent technical staff with relevant degree/diploma must be appointed.
The unit must have adequate infrastructure, testing facilities, and quality systems in place.

MD-5 License Document List

Applicants must submit the following documents online via the CDSCO SUGAM portal:

Covering Letter with details of the application.
Constitution documents – Certificate of Incorporation, Partnership Deed, or Proprietorship Proof.
Plant Master File – layout, location, and manufacturing capacity.
Device Master File – product specifications, intended use, labeling, risk analysis.
ISO 13485 certification.
Site/plant license copies (if any previous registration exists).
Undertaking of compliance with the Medical Device Rules, 2017.
Details of technical staff with qualification certificates.
Quality management system (QMS) documents.
Proof of fee payment (as per notified CDSCO fee structure).

STEP-BY-STEP MD-5 LICENSE APPLICATION PROCESS IN INDIA

Getting an MD-5 license involves both documentation and physical verification. Below is the simplified process:

Step 1: Classification of Device

Identify whether your product falls under Class A or Class B. Classification depends on risk level, intended use, and invasiveness.

Step 2: Registration on SUGAM Portal

Create an account on the CDSCO SUGAM online portal.
Select the MD-5 application form.

Step 3: Preparation of Documents

Compile the Plant Master File and Device Master File.
Ensure ISO 13485 certification is valid.
Collect all undertakings, declarations, and staff details.

Step 4: Submission of Application

Submit online application via Form MD-3, along with prescribed fee.
Application is processed by the State Licensing Authority.

Step 5: Audit/Inspection

SLA may conduct a site inspection to verify compliance with GMP.
Inspectors review QMS, infrastructure, and documentation.

Step 6: Grant of License

If approved, SLA issues MD-5 license via Form MD-5.
This license is valid for 5 years unless suspended or cancelled.

PENALTY FOR OPERATING WITHOUT SUCH LICENCE

Manufacturing medical devices without a valid MD-5 license is a serious offence.

Product Seizure: Authorities can confiscate all unlicensed stock.
Cancellation of future eligibility: Repeated violations may ban the manufacturer from future licensing.
Monetary fines and legal prosecution under Drugs and Cosmetics Act.
Criminal liability: In cases where harm is caused to patients, imprisonment is possible.

Thus, operating without an MD-5 license risks not only your business but also your reputation.

HOW LAWFINITY SIMPLIFIES SUCH LICENCE PROCEDURE?

At Lawfinity, we know that applying for an MD-5 license can feel overwhelming. The process involves multiple forms, strict documentation, and inspections from the authorities. Even a small mistake—like a missing declaration or an incomplete file—can lead to delays or rejections. That’s why our role is to make the entire journey easy and stress-free for you.

Here’s how we simplify the process step by step:

1. Eligibility Assessment

We start by checking whether your medical device falls under Class A or Class B, which are covered under the MD-5 license. This saves you from confusion about the category of your product.

2. Documentation Support

Documents are the backbone of any license. Our experts prepare everything—from the Device Master File that explains product details to QMS compliance papers that prove your factory follows ISO 13485 standards.

3. Application Filing

Once the paperwork is ready, we handle the entire submission process on the CDSCO SUGAM portal. This ensures accuracy and avoids unnecessary delays caused by errors.

4. Inspection Readiness

Before the State Licensing Authority (SLA) visits your site, we guide you on how to stay prepared. From infrastructure checks to staff qualifications, we make sure you’re inspection-ready.

5. End-to-End Guidance

Our support doesn’t end with the approval. We assist you with renewals, amendments, and updates whenever needed, so your compliance is always up to date.

In short, at Lawfinity:

We handle the paperwork, you save time.
We reduce the chances of rejection.
We make licensing a smooth, guided process.

You focus on your business and innovation—we take care of compliance.

MUSINGS FROM THE AUTHOR’S INK

Licensing in the healthcare sector is often perceived as a formality, but in reality, it is the foundation of trust. Every medical device, whether a syringe, a thermometer, or an advanced digital monitor, directly impacts human life. By obtaining an MD-5 license, manufacturers demonstrate more than just compliance with law—they show a genuine commitment to safety, accountability, and credibility. This license ensures that medical devices meet strict quality standards, giving doctors, hospitals, and patients the confidence that what they use is safe and reliable. In an industry where even the smallest error can have life-altering consequences, such assurance is invaluable.

For businesses, an MD-5 license also strengthens market reputation, prevents legal penalties, and paves the way for sustainable growth. It builds trust not just with regulators, but also with customers, investors, and international partners.

At Lawfinity, we help simplify this complex journey. From assessing eligibility and preparing documents to filing applications and guiding you through inspections, our experts ensure a smooth, error-free process. We take the burden of compliance off your shoulders, turning licensing into a badge of credibility.