How to Apply for an MD-16 License (Loan License for Manufacturing)?

An MD-16 License is a special permission granted by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rule, 2017. It allows a company to manufacture medical devices even if it does not own a manufacturing facility. Instead, the company can tie up with a licensed third-party manufacturer (MD 5 license holder) and get the devices produced under its own brand name. In easy words, the MD 16 loan license makes it possible for non-manufacturing businesses to legally produce medical devices in India while staying compliant with CDSCO regulations.

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What is an MD 16 Licence (Loan License for Manufacturing)?

The MD-16 License is a permission issued by the Central Drugs Standard Control Organization under the Medical Device Rules 2017. It allows companies to manufacture without owning a plant. This enables marketing companies to produce medical devices under their brand name while ensuring regulatory compliance.

Why is an MD 16 License Required For Medical Device Manufacturing?

An MD-16 License, also known as a Loan License for Medical Device Manufacturing, is required when a company wants to manufacture medical devices but does not own the manufacturing facility. Instead, they use the premises, machinery, and equipment of another licensed manufacturer to produce their medical devices. This license is crucial for ensuring regulatory compliance and maintaining the safety and quality of medical devices in India.

Regulatory Requirement Under MDR, 2017
Ensures Legal and Safe Production
Accountability Without a Factory
Traceability and Market Surveillance
Quality Control And Labeling Compliance

Who Can Apply For An MD 16 Loan License For Manufacturing in India?

Any individual, company, partnership firm, LLP, or organization that wants to manufacture and sell medical devices under their own brand name without owning a manufacturing facility can apply for an MD-16 License in India.

Startups or entrepreneurs launching a new medical device brand
Pharmaceutical or healthcare companies that want to expand into medical devices
Businesses with no factory of their own but want to manufacture using another company’s approved facility
Importers who also wish to get devices manufactured locally under their own label.

Which Medical Devices Need An MD 16 Loan License For Manufacturing?

An MD 16 Loan License is required for all types of medical devices that are intended to be manufactured through a third-party facility (not owned by you) as long as those devices are regulated under the Medical Device Rules, 2017 in India.

This includes devices across all risk categories, from low risk to high risk if you’re planning to get them made by a licensed manufacturer under your own brand name.

List of common medical devices that require MD 16

Here are a few examples of devices that would require an MD 16 license if you’re not the actual manufacturer:

Class A

Class B

Blood Pressure Monitors
Nebulizers
Pregnancy Test Kits
Digital ECG Machines
Reusable Surgical Instruments

Class C

Blood Dialysis Machines
Ventilators
Implantable Bone Fixation Plates
Orthopedics Implants

Class D

Pacemakers
Heart Valves
Drug-Eluting Stents
Blood Bags
HIV and Hepatitis Test Kits

Documents Required To Apply For the MD 16 License

To apply for an MD-16 license under the Medical Device Rules, 2017, the applicant must submit a set of regulatory, technical, and legal documents to the Central Licensing Authority (CDSCO) via the Online Sugam Portal. Check the list of needed documents to apply for MD 16 License:

Covering Letter
Duly Filled Application Form
Copy of the Manufacturing Site License
Agreement With Contract Manufacturer
Site Master File
Device Master File
Undertaking from the Applicant
Undertaking From the Contract Manufacturer
Details of Technical Staff
Product Labels and Artwork
Product Specification and Test Methods
ISO 13485 Certificate
Power of Attorney/Authorization Letter
Fee Payment Receipt

Procedure To Apply For An MD 16 License (Loan License for Manufacturing)

If you want to get a medical device manufactured by a third-party manufacturer under your own brand name, you need to apply for an MD 16 Loan license from the Central Drug Standard Control Organization (CDSCO).

Step 1: Tie Up With a Manufacturer (MD 5 Holder)

You should partner with a manufacturer that already has a valid MD5 License issued by the CDSCO
This facility will manufacture the medical devices on your behalf.

Step 2: Register on the CDSCO SUGAM Portal

Go to the official SUGAM portal
Create a user ID and Password for your business
Choose the purpose as Loan License for manufacturing of medical devices, MD 16

Step 3: Prepare and Upload Required Documents

Duly Filled Form MD 4 (Application Form)
Covering Letter

Step 4: Pay Government Fees

First, you have to visit the official website
Select the appropriate fee category for the MD 16 license
Pay the fee online
Save the payment receipt and upload it to the SUGAM Portal

Step 5: Submit the Online Application

After uploading all documents and payment proof, submit your application through the SUGAM Portal
Make sure there are no missing documents or errors, as this can delay approval

Step 6: Application Review By CDSCO

The Central Licensing Authority (CDSCO) will review your application
If required, they may ask for additional documents or clarification
If everything is in order, CDSCO will approve your MD 16 license in the form of MD 6

Step 7: Receive License and Start Manufacturing

Once approved, you’ll get the MD 16 license
Your partnered manufacturer (MD 5 Holder)

What is the Timeline To Get an MD 16 License For Manufacturing Medical Devices?

The timeline to get an MD-16 License in India usually takes around 60 to 90 working days (2 to 3 months) from the date of complete application submission.

S.No.	Stage	Time Estimate
1.	Documents Preparation	1-2 weeks
2.	Online Application + Fee Payment	2-3 Days
3.	CDSCO Review & Approval	6-12 Weeks (approx)

How To Renew An MD 16 Loan License For Medical Device Manufacturing?

Renewing an MD 16 License is a simple process if you follow the correct steps on time. The MD 16 license is valid for 5 years, and it should be renewed before it expires to continue manufacturing through a third party.

Check License Expiry Date
Log in to the CDSCO SUGAM Portal
Prepare the Required Documents
Pay the Renewal Fees
Submit the Renewal Application
CDSCO Review and Approval

Common Reasons for Delay or Rejection in MD 16 License Applications

If your MD 16 license application is delayed or rejected, it is usually because of a mistake or missing information in your documents or the process.

Incomplete or Wrong Documents
Improper Loan License Agreement
Invalid or Expired MD5 License of the manufacturer
Wrong Product Classification
Missing Technical Details in DMF/SMF
Unqualified Technical Staff
Non-Compliant Product Labels
Delayed Response to Queries
Wrong or Unpaid Government Fees
Mismatch Between Document and Portal Details

Why Choose ELT Corporate for MD 16 Loan License (Manufacturing Of Medical Devices)?

Getting an MD 16 Loan License can be confusing and time-consuming, but ELT Corporate is the most reliable regulatory consultancy, which makes it simple, smooth, and fast.

Expertise in Medical Device License
End-to-End Support
Error Free Document Preparation
Timely Update & Follow Ups
Fast & Hassle-Free Process
Affordable & Transparent Pricing
Trust by 500+ Client Across India

Need Help Applying for an MD-16 License?

Whether you’re a startup, importer, or healthcare brand wanting to manufacture under your own label, ELT Corporate is here to guide you. Whether you’re a startup, importer, or healthcare brand wanting to manufacture under your own label, ELT Corporate is here to guide you.

We Provide:

Expert guidance on regulatory compliance
Complete document preparation (DMF, SMF, Form MD-4)
Coordination with MD 5 licensed manufacturers
Full support from application to license grant

Reach out to our regulatory experts at ELT Corporate for a hassle-free licensing process.

Call us at 9899997002 or Email us at info@legalmetrologyindia.com

Is an MD 16 License Mandatory for a Contract Medical Device Manufacturing In India?

Yes, an MD 16 License is necessary if you want to manufacture a medical device in India through a third-party arrangement using another company’s licensed facility.

Can A Marketing Company Apply For an MD 16 Loan License Without Owning A Manufacturing Plant?

Yes, marketing companies can apply for an MD 16 Loan License without owning a manufacturing plant.