What is a Test Import/Manufacturing License?

A Test License—also known as a Test Import License (for imported products) or Test Manufacturing License (for locally manufactured devices)—is granted by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. This license allows companies to import or manufacture medical devices strictly for the purpose of testing, analysis, training, or research, and not for commercial sale.

Why You Need a Test License?

Before commercializing a medical device, whether it is a high-risk implant or a diagnostic kit, it must be evaluated for its performance, safety, and regulatory compliance. A Test License is mandatory if:

• You need to test clinical or analytical performance.
• You plan to conduct in-house or third-party testing.
• You require sample units for demonstration, training, or validation.
• You are preparing for clinical trials or regulatory submissions.

Types of Test Licenses

Rico Solutions helps clients secure the appropriate test license based on the nature and category of the device:

1. Form MD-16: Test License for Import
   • Required when importing devices for testing, training, or demonstration.
   • Issued by the CDSCO headquarters.
2. Form MD-12: Test License for Manufacturing
   • Required when manufacturing non-commercial test units locally.
   • Issued by the State Licensing Authority (SLA).

Documentation Assistance by Rico Solutions

Our experienced regulatory experts provide end-to-end support for compiling, reviewing, and submitting all essential documents. These include:

• Cover Letter
• Application in Form MD-16 or MD-12
• Device description and purpose of testing
• Site details of testing/manufacturing
• Undertaking of non-commercial use
• Manufacturing license (if applicable)
• Authorized Indian Agent (for foreign manufacturers)
• Invoice or Purchase Order (in case of imports)
• Fee receipt (as per CDSCO norms)

We ensure that your documentation is accurate, complete, and compliant with the latest CDSCO updates.

Our Process

At Rico Solutions India Private Limited, we follow a transparent, step-by-step process:

1. Initial Assessment
   • Evaluation of device category and test requirements.
   • Determining eligibility for Form MD-12 or MD-16.
2. Documentation & Application
   • Collection of required documents.
   • Application filing with CDSCO/SLA.
3. Liaison & Follow-up
   • Coordinating with the CDSCO/state authorities.
   • Responding to queries or deficiencies.
4. Grant of License
   • Typically issued within 30 working days, if all criteria are met.

Use Cases for Test Licenses

• Importing devices for in-vitro diagnostic (IVD) performance evaluation.
• Manufacturing trial units of a Class C or D implant before final approval.
• Testing software-driven medical devices before deployment.
• Conducting R&D or engineering validation in Indian labs.
• Training healthcare professionals using prototype or demo devices.

Legal Compliance & Validity

• The license is non-transferable and valid for 1 year or as specified.
• Devices imported or manufactured under this license must not be sold commercially.
• All unused test units must be destroyed or documented appropriately.
• Detailed test reports and usage logs may be required for audit.

Why Choose Rico Solutions?

• Decade-long experience in medical device regulatory affairs.
• Seamless liaison with CDSCO and SLA.
• Proven success in test license approval for both startups and global brands.
• Fast turnaround times with minimum compliance errors.
• Customized consulting for startups, importers, and manufacturers.

Connect with Us Today!

Whether you’re planning to import an IVD device from the US or manufacture a prototype Class B device locally, Rico Solutions is here to simplify the regulatory maze. Our team ensures that you get your Test Import or Manufacturing License quickly and hassle-free, so you can move forward with innovation, confidently and compliantly.