How to Get Medical Device Manufacturing License in India | Step-by-Step 2026 Guide
How to Get Medical Device Manufacturing License in India | Step-by-Step 2026 Guide - NKB Regovanta
Table of Contents
38 sections in this regulatory guidance
Want to make medical devices in India but unsure where to start? This guide explains how to get medical device manufacturing license in India, step by step, in plain language. Every company that makes a regulated device here needs a medical device manufacturing license under the Medical Devices Rules, 2017. Without it, you cannot legally make, stock, or sell your product.
The problem is that the process feels confusing. You face risk classes, multiple forms, technical files, and a factory audit. One wrong choice can cost you months.
The opportunity, however, is huge. India's medical devices industry could grow to about USD 50 billion by 2030. In this guide, you will learn the exact steps, forms, documents, fees, and timelines you need.
Quick Answer: How to Get a Medical Device Manufacturing License in India
Here is the short version of the process:
Confirm that your product is a notified medical device.
Find its risk class (A, B, C, or D) under MDR 2017.
Get a test license on Form MD-12 if you need trial batches.
Set up a quality system that meets the Fifth Schedule.
Prepare the Device Master File and Plant Master File.
Apply online on Form MD-3 (Class A/B) or Form MD-7 (Class C/D).
Pass the audit or inspection of your site.
Receive your license on Form MD-5 or Form MD-9.
The sections below explain each step in detail.
What Is a Medical Device Manufacturing License in India?
A medical device manufacturing license in India is official permission to make a specific device at a specific factory. The Central Drugs Standard Control Organisation (CDSCO) controls this system, along with State Licensing Authorities.
The license links your product and your site together. So, if you add a new device or move to a new plant, you must update or apply for a new license.
India brought all medical devices under licensing in phases. Class A and B devices needed licenses from October 2022, and Class C and D devices from October 2023. Today, almost every device made in India falls under these rules.
Who Needs a Medical Device Manufacturing License?
You need this license if you make, assemble, pack, sterilise, or relabel a medical device for sale in India. This applies to startups, MSMEs, large manufacturers, and contract manufacturers.
Foreign companies also need it if they produce devices at a plant in India. If they only ship finished products into India, they need an import license instead.
One group gets an easier route. According to the CDSCO FAQ on Medical Devices Rules, Class A devices that are non-sterile and non-measuring only need online registration, not a full license.
Step-by-Step: How to Get Medical Device Manufacturing License in India (Part 1)
The first four steps prepare your product and your factory. Get these right, and the rest of the process moves much faster.
Step 1: Confirm Your Product Is a Medical Device
Start by checking your product's intended use. If it diagnoses, treats, monitors, or prevents disease, it likely counts as a medical device. Also, check CDSCO's notified lists, which name the devices and their classes.
Step 2: Find the Correct Risk Class
The risk classification of medical devices decides your form, your authority, and your audit. Low-risk products fall in Class A, and high-risk implants fall in Class D. A wrong class can void your whole application, so double-check it.
Step 3: Apply for a Test License if Needed
You may need to make samples for testing or validation before full production. In that case, apply on Form MD-12 for a test license (Form MD-13). It stays valid for three years.
Step 4: Build a Fifth Schedule Quality System
MDR 2017 requires a Fifth Schedule QMS, a quality system covering design, purchasing, production, testing, and complaints. It closely follows ISO 13485:2016. ISO 13485 certification is not mandatory, but it makes the audit much easier.
Step-by-Step: How to Get Medical Device Manufacturing License in India (Part 2)
The next four steps cover your documents, your application, and the audit.
Step 5: Prepare the DMF and PMF
The Device Master File (DMF) describes your device. It covers design, materials, risk analysis, test reports, labels, and stability data. The Plant Master File (PMF) describes your factory. It covers layout, equipment, utilities, staff, and environment controls.
Step 6: Apply Online and Pay the Fee
Create an account on the CDSCO MD Online portal or the National Single Window System. Then upload your DMF, PMF, and supporting papers. File Form MD-3 for Class A or B, or Form MD-7 for Class C or D, and pay the fee online.
Step 7: Pass the Audit or Inspection
For Class B devices, a CDSCO-registered notified body audit checks your quality system. For Class C and D devices, CDSCO officers inspect your site. As per the CDSCO FAQ, this inspection usually happens within 60 days of a satisfactory application.
Step 8: Receive Your License
After a successful audit, you receive the MD-5 license for Class A or B, or the MD-9 license for Class C or D. Display the license number on your labels and keep records ready for future checks.
Medical Device Manufacturing License Forms by Risk Class
Each risk class follows its own form and authority. The table below gives you a quick reference.
Forms and authorities for a medical device manufacturing license in India:
| Class | Risk | Examples | Apply On | License Granted On | Authority | Audit Before Grant |
|---|---|---|---|---|---|---|
Class A | Low | Bandages, tongue depressors | MD-3 | MD-5 | State | Usually not |
Class B | Low-moderate | Thermometers, needles | MD-3 | MD-5 | State | Notified body audit |
Class C | Moderate-high | Ventilators, bone implants | MD-7 | MD-9 | Central (DCGI) | CDSCO inspection |
Class D | High | Heart valves, stents | MD-7 | MD-9 | Central (DCGI) | CDSCO inspection |
Keep in mind that sterile or measuring Class A devices still need a full license. Only non-sterile, non-measuring Class A devices qualify for simple registration.
Documents Required to Get a Medical Device Manufacturing License in India
A complete file is the fastest way through review. Most query letters come from missing or mismatched documents.
Key documents for your application:
| Document | Purpose |
|---|---|
Company constitution papers | Proves the legal identity of your firm |
Site ownership or rent agreement | Shows your right to use the premises |
Plant Master File | Describes your factory, equipment, and staff |
Device Master File | Describes your device, risks, and testing |
QMS manual and SOPs | Shows Fifth Schedule compliance |
Technical staff details | Proves qualified people run production and testing |
Test reports | Shows safety and performance |
Labels and instructions for use | Shows labeling rule compliance |
Undertaking and fee receipt | Confirms declarations and payment |
Use the same device name, model numbers, and version dates across every document. Small mismatches are one of the most common reasons for delays.
Fees, Validity and Timelines for a Medical Device Manufacturing License
Government fees depend on your device class, the number of sites, and the number of distinct devices. The figures below follow the official fee structure summarised in Artixio's CDSCO cost guide.
Government fees for a medical device manufacturing license in India:
| Class | Fee per Site | Fee per Distinct Device | Retention Fee (Every 5 Years) |
|---|---|---|---|
Class A and B | ₹5,000 | ₹500 | Same as license fee |
Class C and D | ₹50,000 | ₹1,000 | Same as license fee |
Your license has no fixed expiry date. It stays valid as long as you pay the retention fee every five years. If you pay late, a penalty of 2% per month applies.
Timelines depend on how ready your files and factory are. In practice, Class A and B licenses often take three to five months. Class C and D licenses usually take six to nine months because of central review and inspection.
Budget Planning: Total Cost to Get a Medical Device Manufacturing License in India
Government fees are only one part of your budget. When you plan how to get medical device manufacturing license in India, account for every cost that comes before the application.
Testing often costs the most. Depending on the device, you may need biocompatibility, electrical safety, sterility, or performance tests at accredited labs. Next comes the factory. Cleanrooms, validated equipment, and calibrated instruments need real investment, especially for sterile products.
Quality system work also takes time and money. You will write SOPs, train staff, and run internal audits before the official audit. Finally, add professional fees if you hire a regulatory expert, plus a buffer for query responses.
A simple rule helps here. Build your budget around your device class. Class A and B projects usually need far less testing and infrastructure than Class C and D projects.
Government Support for Indian Medical Device Makers
The Indian government actively promotes local medical device manufacturing. It offers incentive schemes, dedicated medical device parks, and single-window approvals through the National Single Window System.
These programmes can lower your setup costs and give you access to shared testing and sterilisation facilities. The Department of Pharmaceuticals publishes details of current schemes and eligibility.
However, incentives do not replace licensing. Every unit inside a medical device park still needs its own license under MDR 2017. So, treat government support as a cost advantage, and keep your compliance plan on track from day one.
Factory and Staff Requirements You Must Meet
Your factory must match the type of device you make. For example, sterile devices need controlled cleanrooms, validated sterilisation, and environmental monitoring. Non-sterile devices still need clean, organised, and well-maintained areas.
You also need competent technical staff. MDR 2017 expects qualified people, usually with a degree in engineering, pharmacy, or science plus relevant experience, to supervise production and testing. Keep their certificates and training records ready.
Finally, maintain calibration records, pest control logs, and equipment validation reports. Auditors often ask for these first, and gaps here can fail an otherwise strong application.
Manufacturing License vs Registration vs Import License
Many first-time applicants confuse these three permissions. Choosing the right one early saves time and money.
A manufacturing license lets you make devices at an Indian site. Registration covers only non-sterile, non-measuring Class A devices and involves a simpler process. An import license, granted on Form MD-15, lets you bring foreign-made devices into India for sale.
For example, a brand that imports devices today and later opens a local plant will need both licenses at different stages. Planning both together avoids gaps in supply.
Common Mistakes That Slow Down Your License
Most delays come from avoidable errors. Watch out for these common problems.
Wrong risk class sits at the top of the list. It forces a fresh application and a new fee. Weak risk management files come next, because reviewers want a clear link between each hazard, its control, and its test result.
Missing factory records also cause failures. For instance, an auditor may reject a site without cleanroom validation or calibration logs. Unqualified technical staff is another common gap.
Lastly, many firms change a supplier, material, or design after approval without telling CDSCO. This can put the license at risk and trigger penalties.
DIY vs Expert Help: How to Get Your Medical Device Manufacturing License Faster
You can file on your own, especially for simple Class A devices. However, higher-risk devices need deeper technical files and audit readiness. That is where expert help often pays for itself.
Comparison of DIY filing and expert-led filing:
| Factor | DIY Filing | Expert-Led Filing |
|---|---|---|
Device classification | Self-assessed | Checked against CDSCO lists |
DMF and PMF quality | Varies | Audit-ready and referenced |
Audit preparation | Limited | Mock audit and gap closure |
Query handling | Slow | Fast, with technical answers |
Overall timeline | Longer, with more rework | Shorter and more predictable |
If you want a deeper look at what expert support covers, read our guide on choosing a CDSCO manufacturing license consultant.
How to Choose the Right Regulatory Partner
If you decide to get help, choose carefully. Use these points to compare options:
Ask for proof of past MD-5 and MD-9 approvals for devices like yours.
Check that the team includes engineers or scientists who can write a technical DMF.
Confirm that they run mock audits before the real inspection.
Request a fixed-scope quote that lists government fees and professional fees separately.
Make sure they offer support after approval, including retention fees and change approvals.
A partner who meets these points will make the process smoother and more predictable.
What Applicants Discuss Online About Licensing
Founders and quality managers often share their experiences in online communities. You can find many threads in Reddit discussions on medical device licensing in India and CDSCO questions in r/StartUpIndia.
Common questions include how long approval takes, whether registration is enough, and how much testing costs. Many posters also ask whether they can file without help. The general view is that simple Class A products are manageable alone, but higher classes benefit from expert guidance.
These discussions give helpful real-world context. Still, always confirm advice against official CDSCO notices before acting on it.
What to Do After You Get Your License
Getting the license is only the beginning. You must keep your plant and products compliant every day to protect your regulatory compliance in India.
Report serious adverse events, keep complaint records, and run regular internal audits. Get CDSCO approval before major changes, such as a new site or a design change that affects safety. Pay your retention fee on time every five years.
Also, follow labeling rules on every unit, including the license number and manufacturing details. Explore our full range of medical device regulatory services for ongoing support.
Frequently Asked Questions About Getting a Medical Device Manufacturing License in India
What is the first step to get a medical device manufacturing license in India?
The first step is to confirm that your product is a medical device and identify its risk class. This decision sets your form, licensing authority, and audit route. Anyone learning how to get medical device manufacturing license in India should start here, because a wrong class can void the whole application.
Which authority issues a medical device manufacturing license?
State Licensing Authorities issue licenses for Class A and B devices on Form MD-5. The Central Licensing Authority, under the Drugs Controller General of India, issues licenses for Class C and D devices on Form MD-9. Both follow the Medical Devices Rules, 2017.
How long does it take to get a medical device manufacturing license in India?
Class A and B licenses typically take three to five months. Class C and D licenses usually take six to nine months because of central review and a site inspection. A complete file and quick query responses can shorten the timeline. You can find more practical guides in our regulatory insights library.
Can a startup get a medical device manufacturing license in India?
Yes. Startups can get a medical device manufacturing license in India if they have a suitable site, qualified staff, a working quality system, and complete technical files. Many startups begin with a test license to build and test samples before applying for the full license.
Is ISO 13485 required for a manufacturing license?
ISO 13485 certification is not strictly required. However, MDR 2017 requires a Fifth Schedule quality system, which closely mirrors ISO 13485. Firms that already hold ISO 13485 usually find the audit easier and faster.
Can a foreign company get a medical device manufacturing license in India?
Yes, if it makes devices at a site in India. The company needs an Indian legal entity, a compliant site, and the same documents as local firms. Foreign firms that only export to India need an import license instead. We support clients across many medical device industries.
Questions & Answers
How do I get a medical device manufacturing license in India?
To get a medical device manufacturing license in India, classify your device, set up a Fifth Schedule quality system, and prepare your Device and Plant Master Files. Then apply online on Form MD-3 or MD-7, pass the audit, and receive your license on Form MD-5 or MD-9.
What is the fee for a medical device manufacturing license in India?
For Class A and B devices, the fee is ₹5,000 per site and ₹500 per device. For Class C and D devices, the fee is ₹50,000 per site and ₹1,000 per device. You pay the same amount as a retention fee every five years.
Do Class A medical devices need a manufacturing license?
Sterile or measuring Class A devices need a full manufacturing license on Form MD-5. However, non-sterile and non-measuring Class A devices only need online registration with CDSCO. This makes the process much simpler for basic, low-risk products.
Where do I apply for a medical device manufacturing license?
You apply online through the CDSCO MD Online portal or the National Single Window System. Create a company account, upload your documents, choose the correct form for your device class, and pay the government fee online.
Start Your Licensing Journey With Confidence
Now you know how to get medical device manufacturing license in India, from classification to final approval. The process rewards careful planning, complete files, and a factory that is ready for audit. NKB Regovanta helps manufacturers classify devices, write audit-ready DMFs and PMFs, and pass CDSCO inspections. Explore our CDSCO and medical device regulatory services or visit the NKB Regovanta homepage to speak with our team. With the right plan, your medical device manufacturing license in India can arrive sooner and with fewer surprises.
NKB Regulatory Experts
Verified Regulatory ExpertM.Pharm, RAC (Global Regulatory Affairs Certified)
Senior Regulatory Affairs & Quality Assurance Specialists at NKB Regovanta Solutions Pvt. Ltd., guiding MedTech manufacturers worldwide across CDSCO, US FDA, EU MDR, and ISO 13485 compliance.
Facing medical device compliance bottlenecks or Notified Body review findings?
NKB Regovanta conducts thorough regulatory gap assessments, dossier remediation, and health authority liaison to secure market approvals with confidence.