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Wed, Jun 03 2026
Raju Karn
Medical device manufacturing in India is growing rapidly. Many companies want to launch medical devices under their own brand but do not have their own manufacturing facility. Building a manufacturing unit requires significant investment, infrastructure, equipment, technical staff and regulatory approvals. To solve this problem, CDSCO allows businesses to manufacture medical devices through an approved third-party manufacturer by obtaining a Medical Device Loan License.
A Loan License allows one company to use the manufacturing facilities of another licensed manufacturer while selling the product under its own name. This system helps startups, importers, healthcare companies, and brand owners enter the market without establishing a factory from scratch. The entire process is regulated under the Medical Devices Rules, 2017 and involves several application forms including Form MD-4, Form MD-5, Form MD-6, Form MD-8, Form MD-9, and Form MD-10.
This guide explains the complete CDSCO Medical Device Loan License process in simple language so that any business owner can understand how it works.
A Medical Device Loan License is a permission granted by the licensing authority allowing an applicant to manufacture medical devices using the manufacturing facilities of another company that already holds a valid manufacturing license.
In simple words:
• Company A owns a manufacturing facility.
• Company B wants to sell medical devices under its own brand.
• Instead of building a factory, Company B uses Company A's licensed facility.
• Company B applies for a Loan License from CDSCO.
This arrangement is commonly used by:
▸Medical device startups
▸Healthcare brands
▸Distributors launching private-label products
▸Businesses entering the medical device sector
▸Companies expanding their product portfolio
Setting up a medical device manufacturing facility can take months or even years.
A Loan License offers several advantages:
Businesses do not need to purchase land, machinery, or manufacturing equipment.
Products can reach the market much faster because manufacturing infrastructure already exists.
Many operational responsibilities remain with the licensed manufacturing facility.
The applicant can market and sell products under its own brand name.
Companies can test market demand before investing in their own factory.
Different application forms are used depending on the risk classification of the medical device.
Application for Loan License for manufacturing Class A and Class B medical devices.
Loan License issued for Class A and Class B medical devices.
Application for manufacturing license of Class A and Class B devices used by facility owners.
Application for Loan License for manufacturing Class C and Class D medical devices.
Loan License issued for Class C and Class D medical devices.
Manufacturing license granted for Class C and Class D medical devices to facility owners.
The application form and approval authority depend directly on the device classification:
The applicant should:
➤ Be a legally registered business entity
➤ Have an agreement with a licensed manufacturer
➤ Ensure the manufacturing site has valid CDSCO approval
➤ Appoint competent technical personnel where required
➤Maintain quality management documentation
Eligible entities include:
✓ Private Limited Companies
✓ LLPs
✓ Partnership Firms
✓ Proprietorship Businesses
✓ Medical Device Startups
Although requirements may vary depending on device class, commonly required documents include:
→ Company incorporation documents
→ PAN card
→ GST registration
→ Authorized signatory details
→ Manufacturing agreement
→ Existing manufacturing license of facility owner
→ Device details and specifications
→ Quality management records
→ Site master file
→ Device master file
→ Undertakings and declarations
Accurate documentation plays a major role in avoiding delays.
First, you need to find a manufacturing company (factory) that already has a valid CDSCO manufacturing license.
This company is called the Host Manufacturer.
You will not build your own factory. Instead, you will use their approved facility, machines, and setup to manufacture your medical device.
Important point: Without a licensed manufacturer, you cannot apply for a Loan License.
Next, you must sign a legal agreement with the Host Manufacturer.
This agreement clearly explains:
This document is very important because CDSCO checks it carefully.
Now you must check what type of medical device you are manufacturing.
Medical devices are divided into 4 risk categories:
This step is important because it decides:
You must collect and prepare all required documents.
This includes:
If documents are incomplete, the application may be delayed or rejected.
Now you submit your application online through the CDSCO SUGAM Portal.
You must use the correct form based on device class:
After submission, you will receive an application number to track progress.
After submission, CDSCO or the State Authority will:
If anything is missing, they may ask for corrections.
In some cases, officials may visit the manufacturing facility.
They will check:
This step is more strict for Class C & D devices.
If everything is approved, the authority issues your Loan License:
After this:
Many applications face delays because of avoidable mistakes.
Common issues include:
⚠️ Incorrect device classification
⚠️ Incomplete agreements
⚠️ Missing technical documents
⚠️ Inconsistent product information
⚠️ Errors in uploaded forms
⚠️ Outdated manufacturing licenses
⚠️ Poor quality management documentation
Careful preparation can significantly reduce approval time.
Getting approval is only the beginning.
The license holder must continue to:
⇨ Maintain product quality
⇨ Follow Medical Devices Rules, 2017
⇨ Maintain complaint records
⇨ Report adverse events when required
⇨ Cooperate during inspections
⇨ Keep documentation updated
⇨ Follow labeling requirements
⇨ Ensure traceability of products
Non-compliance can result in suspension or cancellation of the license.
Obtaining a CDSCO Medical Device Loan License can be challenging, especially for businesses applying for the first time.
PSR Compliance provides:
✔️ Loan License eligibility assessment
✔️ Device classification support
✔️ Documentation preparation
✔️ Manufacturing agreement review
✔️ Portal filing assistance
✔️ Regulatory compliance guidance
✔️ Query response support
✔️ End-to-end application management
Our team helps businesses complete the process smoothly while reducing delays and compliance risks.
The CDSCO Medical Device Loan License system provides a practical route for businesses that want to manufacture medical devices without establishing their own factory. Through Forms MD-4 to MD-10, companies can legally use an approved manufacturing facility while marketing products under their own brand.
Understanding the correct form, device classification, documentation requirements, and compliance obligations is essential for a successful application. With proper planning and regulatory support, businesses can enter the medical device market faster and more efficiently while remaining fully compliant with Indian regulations.
Get expert assistance for Form MD-4, MD-5, MD-8, and MD-9 applications. We help with documentation, application filing, compliance review, and approval support.
📞 Call: +91 87961 04190📧 Email: support@psrcompliance.com
A Medical Device Loan License is a permission issued under the Medical Devices Rules, 2017. It allows a company to manufacture medical devices using the factory, machines, and infrastructure of another already licensed manufacturer. The applicant does not need to own a factory.
Any legally registered business such as a private limited company, LLP, partnership firm, or proprietorship can apply. However, the applicant must have a valid agreement with a licensed manufacturing facility (Host Manufacturer).
The application form depends on the device risk class:
Key documents include:
Yes. ISO 13485 certification is required for the manufacturing facility. It ensures that the Quality Management System meets international standards for medical device safety and quality.
The typical timeline is:
The timeline may vary depending on document quality and compliance readiness.
Applications must be submitted online through:
All documents, forms, and payments are handled digitally.
Yes. The Loan License holder owns the brand and product. The Host manufacturer only provides the facility and infrastructure. The final product is marketed under the applicant’s brand name.
If the Host manufacturer’s license is suspended or cancelled, production must stop immediately. The Loan License holder must either:
Yes. That is the main purpose of a Loan License. You do not need your own factory, but you must have a valid agreement with a licensed manufacturer.
Inspection is not always mandatory for Class A & B devices, but it is commonly required for Class C & D devices. Authorities verify GMP, QMS, safety systems, and production setup during inspection.
Book your free consultation with our specialists today.