Loan License for Medical Devices

A loan license for medical devices works as a legal permission that allows a business without its own manufacturing plant to produce medical devices at a licensed facility. This type of license supports new companies and small manufacturers by giving access to a certified production unit where devices are made under expert supervision.

In India, the Central Drugs Standard Control Organisation (CDSCO) takes care of all rules for medical devices under the Medical Devices Rules, 2017. Every medical device must stay safe, work well, and follow all quality rules. A loan license helps a company make devices in another approved factory. Even if the work is done outside, the device still must follow the same strict rules set by the government.

The loan license holder and the factory work together under a legal agreement. The approved factory gives machines, space, and trained workers for the making of the device. The loan license holder handles the design, papers, and all permissions for the device. Every step in making the device is checked and recorded, so the safety and quality are under control at all times.

The loan license helps companies launch safe medical devices in the market with low investment. It supports innovation and grows the domestic medical device industry by allowing many stakeholders to participate without building expensive factories.

A loan license helps medical device companies grow faster. It makes the work easier and saves money and time. Here are the main benefits:

• Low Investment Requirement: A company can start making medical devices without building its own factory. This helps the company spend less money and enter the market faster.
• Faster Production Setup: Manufacturing starts quickly since approved facilities and equipment are already available.
• Support for Innovation: Startups and research-based companies can focus on new product design and testing while a licensed facility manages production.
• Better Quality Compliance: Production happens in a certified unit following CDSCO standards, improving safety and performance.
• Manufacturing Flexibility: A business can scale production up or down based on demand without any major infrastructure changes.
• Boost to Make in India: The license supports domestic manufacturing, increases local product availability, and reduces import dependence.

Who Needs a Loan License for Medical Devices?

Here are the groups that need a CDSCO loan license:

• Businesses are designing medical devices, but lack a manufacturing unit
• Importers wanting to start local production in India
• Startups entering the medical device market with low investment
• Companies outsourcing complete or partial manufacturing
• Research institutions producing innovative medical devices for commercialization

Forms required for a loan license for medical devices are:

These forms help regulate manufacturing permissions for different risk-based medical devices in India.

Why Manufacturers Opt for a Loan License?

Many medical device businesses prefer a loan license because it offers a simple and cost-effective entry into the industry. Here are the main reasons:

• Cost-Effective Manufacturing: No need to invest money in building and maintaining a production facility.
• Access to Certified Technology: Production uses advanced machinery and approved infrastructure already maintained by the manufacturer.
• Faster Market Launch: Manufacturing starts quickly after approval, reducing delays and business risks.
• Business Growth and Expansion: Focus stays on product innovation, design, marketing, and distribution while production is handled by experts.

The authorities responsible for granting a loan license for medical devices are different and depend on the classes.

• Class A & B Devices – SLA (State Licensing Authority)

The SLA gives approval to make low and medium-risk medical devices. The application is filed online through Form MD-4. The officers check all papers and make sure the rules are followed. When everything is right, the license is given in Form MD-6. The SLA makes sure the factory always keeps good safety and quality while making the devices.

• Class C & D Devices – CLA (Central Licensing Authority)

The CLA permits high-risk medical devices. The application is sent using Form MD-8. The officers check all papers and visit the factory within 60 days to see if the work is done properly. When the rules are fully followed, the license is given in Form MD-10. The CLA keeps strict watch on these devices because they are used for serious medical care.

These are the basic conditions:

• A contract must exist between the license holder and the manufacturing facility
• The facility must have a valid manufacturing license for the same device class
• Skilled technical staff must supervise production and testing
• A proper Quality Management System must be followed (ISO 13485 recommended)
• All testing, calibration, and safety procedures must meet CDSCO guidelines
• The license holder must take responsibility for compliance and approvals

Here are the important documents needed:

• Form MD-4 or Form MD-8 (as per device class)
• Valid manufacturing license of the factory
• Agreement between the license holder and the manufacturing site
• Site Master File / Plant Master File
• Device Master File with technical details, design, and risk report
• QMS certificates and SOPs
• Sterilization validation, if the device is sterile
• Company registration certificates, GST proof, and address proof

The application process for a loan license is different for different classes. Class A&B have different and Class C&D have different. Underneath, they are defined properly.

Loan License Application Process for Class A & B Medical Devices

Class A and B devices fall under low and medium-risk categories. The State Licensing Authority (SLA) manages the manufacturing loan license for these devices. The application must follow the Medical Devices Rules, 2017. Here are the key steps:

• Online Registration on the SUGAM Portal: The first step is to register the business on the CDSCO SUGAM portal. The company details, team details, and needed papers are uploaded online. The portal then gives a username and password to continue the process. This helps the officers check and follow every step of the license process easily.
• Submission of Form MD-4: Form MD-4 must be filed with all required technical details of the medical device. The agreement between the license holder and the manufacturing site must be submitted. Documents such as QMS details, device design, risk analysis, and workforce qualification reports are attached for review by SLA.
• Document Examination and Site Verification: The SLA reviews every document uploaded on the portal. If required, regulatory officials visit the manufacturing facility to verify compliance with MDR 2017. This includes inspection of hygiene, calibration records, testing labs, storage systems, and equipment maintenance.
• Approval in Form MD-6: When the authority is satisfied with compliance, the loan license is granted in Form MD-6. This permission allows the making, selling, and supply of Class A or B devices from the approved factory. The license stays active when the fees are paid on time and the factory keeps following all quality rules.

Loan License Application Process for Class C & D Medical Devices

Class C and D devices fall under the high-risk category. The Central Licensing Authority (CLA) handles loan license approval. The process is stricter because these devices support critical medical treatments. These are the main steps:

• Login and Application Filing through SUGAM: The application begins with an active login on SUGAM. A legal contract must confirm the borrowed manufacturing facility arrangement. Full details of product testing, performance studies, and risk classification are entered before moving to the next step.
• Submission of Form MD-8: Form MD-8 is uploaded with the complete Device Master File, sterilization controls, biological safety reports, and national/international compliance certificates. QMS, as per MDR 2017, and processes similar to ISO 13485 remain essential for review.
• Audit and Inspection by Regulatory Officers: High-risk devices need deeper scrutiny. CLA officers conduct a full inspection within 60 days. They check critical manufacturing systems, including cleanroom design, sterilization validation, material traceability, packaging integrity, and electronic records. Only flawless compliance is accepted for approval.
• Grant of License in Form MD-10: After all the safety checks are done, the company gets a loan license in Form MD-10. This license gives permission to make, share, and sell Class C and D medical devices legally in India. Regular checks continue to make sure the products stay safe for patients and work properly in the market.

A loan license stays active all the time unless the authority stops or cancels it. The company must pay a fee every five years depending on the type of device. All safety, quality, and rule requirements must always be followed. If there is any change in the factory, owner, or machine setup, the authority must be informed. Routine audits and inspections ensure that device quality remains safe for users. The continuous compliance approach makes sure that safe and effective medical devices reach hospitals, clinics, and patients without interruption.

Corpseed is one of the top consulting firms, offering comprehensive assistance in the medical device and pharmaceutical compliance, guiding businesses through the necessary processes. We support companies in getting a loan license in a smooth and simple way. Our team helps at every step so that the license is approved without trouble. Here is how we help:

• Expert Guidance: We explain every rule in easy words and help in choosing the correct device class.
• Document Support: We prepare and check all required papers so they are correct and complete.
• Quality Compliance Support: We make sure the factory and products follow all safety and quality rules.
• Communication with Authority: We handle all queries from CDSCO and solve issues quickly.
• End-to-End Assistance: We stay involved from the first step of the application to the final license approval.