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A loan license for In-Vitro Diagnostic (IVD) devices is a legal document that allows a business to manufacture IVD devices at a third-party manufacturing site that has a proper license. The loan license for IVD manufacturing is released under the Medical Device Rules, 2017, by the State Licensing Authority (SLA) or Central Drugs Standard Control Organization (CDSCO) depending on the device classification.
For small-scale units and entrepreneurs who are interested in entering the IVD manufacturing business, production in their own factory may not always be feasible with regard to the huge investment and regulatory expenses involved. It is here that the option of obtaining a loan license to manufacture IVD devices is an economic and feasible alternative.
Any individuals or companies that want to launch or sell their line of IVD products but do not have their own manufacturing infrastructure need to apply for IVD loan license.
A loan license can provide several advantages for a business from both a strategic and fiscal perspective.
To be eligible for a loan license in IVD manufacturing, the applicant should fulfill the following eligibility criteria:
To apply for IVD loan license, you need to submit several documents to the State Licensing Authority or CDSCO.
The following is a concise description of the procedure for obtaining an IVD loan license.
Get in touch with our experts to discuss your IVD loan license requirements and business plan.
Find a third-party manufacturer who is licensed to make IVD devices. Ensure their facility complies with all regulations.
Enter into a written agreement with the chosen manufacturer defining the role, responsibility, manufacturing terms, and quality tests.
Draw up a detailed list of IVD products you wish to produce under the loan license. Provide product names, types, categories, and specifications.
Fill out the appropriate application form (MD-4 for Class A & B or MD-8 for Class C & D). Include all supporting documents and submit to SLA or CDSCO.
Pay the inspection fee and application fee along with your application as directed.
A drug inspector will visit the manufacturing facility to verify if it satisfies every regulatory requirement, such as hygiene, quality control, and security.
Provided the inspection has gone well and all the paperwork is in order, the Authority will issue the loan license (MD-6 or MD-10).
After receiving your license, you can start producing your IVD devices under your brand name at the third-party facility.
The loan license for IVD manufacturing is typically valid for a period of 5 years, subject to renewal. To maintain the license, businesses must:
We manage every step, document, and follow-up with the authority so you can focus on your IVD business.
We verify your eligibility and ensure all required documents are complete and valid.
Complete loan license application drafting and verification to ensure error-free submission.
Help in finding and verifying licensed third-party manufacturers for your IVD products.
Assistance in drafting manufacturing agreements that comply with regulatory requirements.
Complete application filing through the SUGAM portal or offline submission.
We respond to all queries from the authority on your behalf.
Guidance on preparing the manufacturing facility for inspector visits.
Regular follow-up with SLA/CDSCO to ensure timely processing of your application.
Assistance with post-license compliance, renewals, and regulatory updates.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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