What is a Test Import/Manufacturing License?

A Test License is mandatory when a company wants to:

• Import IVD devices for the purpose of testing, evaluation, validation, or clinical investigations.
• Manufacture IVD devices solely for test and evaluation before commercial production begins.

This license does not permit sale or commercial distribution and is only for R&D, testing, or regulatory clearance activities.

Why You Need a Test License for IVD Devices

With increased regulatory scrutiny on diagnostic devices, a Test License (Form MD-16 for import / MD-17 for manufacturing) ensures that devices undergo appropriate performance checks and clinical validations before entering the Indian market. It is an essential regulatory step before:

• Clinical trials
• Performance evaluation studies
• Validation against Indian diagnostic parameters
• Preparing data for full import/manufacturing license application

Who Needs This License?

You require a Test Import/Manufacturing License if you are:

• An IVD product manufacturer (domestic or overseas)
• A contract research organization (CRO)
• A clinical trial sponsor
• A medical lab introducing a new diagnostic solution
• A distributor validating imported IVD kits or devices

Documents Required

Rico Solutions assists with end-to-end documentation including:

• Application in Form MD-16 or MD-17 (depending on import or manufacture)
• Cover letter explaining purpose and scope of testing
• Device master file / product details
• IFU (Instructions for Use) and packaging details
• Undertaking that devices will not be sold
• Details of testing centers or laboratories
• CDSCO portal registration and applicant details

How Rico Solutions Supports You

As regulatory experts in the Indian medical device space, Rico Solutions India Private Limited provides:

• Regulatory assessment for product eligibility
• Drafting and filing of MD-16/MD-17 license application
• Guidance on selecting CDSCO-approved laboratories
• Follow-up with CDSCO for timely approvals
• Pre- and post-licensing compliance assistance

Key Benefits of Working with Us

• Fast processing and CDSCO coordination
• Error-free documentation and expert guidance
• Dedicated project manager for your license
• Support across In Vitro Diagnostics (IVD), reagents, kits, and analyzers
• Seamless transition from test license to full Import or Manufacturing License

Turnaround Time

Generally, CDSCO issues the test license within 45-60 days, subject to the completeness of documentation and product classification. With Rico Solutions, we ensure your application is:

• Fully compliant
• Technically accurate
• Supported with expert insights to avoid delays or rejections

Why Choose Rico Solutions India Private Limited?

With years of experience navigating the Indian medical device regulatory system, Rico Solutions India Private Limited is your trusted partner in obtaining all forms of licenses, especially for complex and high-scrutiny categories like In Vitro Diagnostics.

We not only help you get your test license but also provide:

• Post-approval change support
• Endorsement services
• Full import/manufacturing license filing
• Class A NSNM and IVD registrations

Industries & Clients We Serve

Our IVD Test License support is trusted by:

• Global IVD manufacturers entering Indian markets
• Labs launching indigenous diagnostic technologies
• Healthcare startups with proprietary IVD solutions
• Medical research organizations and clinical labs

Stay Compliant, Stay Ahead

With stricter compliance under Medical Device Rules, 2017, non-adherence can lead to delays, rejections, or legal liabilities. Avoid this risk by partnering with Rico Solutions India Private Limited — your end-to-end regulatory compliance expert for all IVD device licensing needs.