In Vitro Diagnostic (IVD) Product Regulatory Services

In Vitro Diagnostic (IVD) devices are crucial for disease detection, monitoring, and treatment planning. In India, these products are regulated under the Medical Device Rules, 2017, governed by the Central Drugs Standard Control Organization (CDSCO). Whether you are planning to import, manufacture, or make regulatory changes to your IVD products, Rico Solutions is your trusted partner for accurate documentation, efficient coordination, and faster approvals.

In Vitro Diagnostic Import License

Importing IVD devices into India requires a valid Import License under Form MD-15, as per the provisions of the Medical Device Rules. At Rico Solutions, we streamline the entire application process by ensuring proper documentation, dossier preparation, device classification, and liaison with the CDSCO.

Our Import License Services Include:

• Device classification (risk-based: Class A to D)
• eSUGAM portal registration and submission
• Legal and regulatory documentation
• Compilation of the Common Submission Dossier Template (CSDT)
• Coordination with overseas manufacturers for Technical Files
• Representation during regulatory queries or audits

Why Choose Us:
With our in-depth understanding of CDSCO compliance and our relationships with regulatory authorities, we help reduce timelines, avoid documentation errors, and fast-track license approvals.

In Vitro Diagnostic Manufacturing License

If you’re planning to manufacture IVD devices in India, obtaining a Manufacturing License under Form MD-5 or MD-9 is mandatory, depending on the risk classification. Rico Solutions provides complete consultancy for facility setup, documentation, site compliance, and quality assurance processes required for license approval.

Our Manufacturing License Support Includes:

• Plant layout guidance as per Schedule IV
• Application filing via CDSCO SUGAM portal
• Preparation of Device Master Files and Site Master Files
• Establishment of Quality Management Systems (ISO 13485 compliance)
• Liaising with State and Central Licensing Authorities (SLA/CLA)
• On-site audit preparation and training

From Class A (low-risk) to Class D (high-risk) IVD devices, our experts tailor solutions to match your product specifications and compliance needs.

Post Approval Change for IVD Devices

Once the license is granted, manufacturers and importers may need to modify details like product name, manufacturing site, packaging, labeling, etc. These changes are subject to CDSCO approval through a Post Approval Change process.

Types of Post-Approval Changes:

• Change in manufacturer address or facility
• Changes in formulation or design
• Packaging updates
• Label and leaflet modifications
• Additional intended use
• Product specification updates

How We Assist:

• Evaluation of the type of change and applicable regulatory pathway
• Preparation and submission of application under Form MD-6 or MD-16
• Clarification and follow-up with the concerned authorities

With Rico Solutions, you can rest assured that your post-market changes are handled with precision and compliance, ensuring uninterrupted business operations.

Test Import/Manufacturing License for IVD

For research, clinical validation, or testing purposes, businesses can apply for a Test License under Form MD-12 or MD-13. This license allows the import or manufacture of IVD products in limited quantities for non-commercial use.

We Provide Assistance With:

• Identifying the appropriate license category
• Preparing justification letters and technical data
• Liaising with CDSCO for minimal delays
• Handling logistics and documentation for customs clearance

Whether you’re conducting pre-clinical evaluation or third-party analysis, Rico Solutions ensures hassle-free Test License approvals.

Endorsement Services for IVD Products

Endorsements are required when you seek approval for additional models, variants, or product configurations under an already approved license. Our team helps ensure that each endorsement application is thoroughly documented and technically compliant.

Our Endorsement Services Include:

• Technical file preparation for new models or variants
• Justification letters and declarations
• Submission of application via the SUGAM portal
• Clarifications and compliance tracking

Rico Solutions accelerates the process while ensuring that all extensions are legally compliant with India’s regulatory norms.

Class A NSNM Registration for IVD Devices

Non-sterile, non-measuring (NSNM) Class A devices are considered low-risk and follow a simplified registration process. However, compliance with CDSCO norms is still mandatory for selling such products in India.

Our Class A NSNM Registration Services Include:

• Preparation of Device Master File (DMF) and Plant Master File (PMF)
• Declaration of Conformity (DoC)
• Device categorization and product listing
• Registration with State Licensing Authorities (SLA)

We take care of the end-to-end process, helping you maintain compliance without getting lost in bureaucratic complexities.

Why Choose Rico Solutions India Private Limited?

At Rico Solutions, our mission is to empower medical and diagnostic device companies by simplifying the regulatory journey. Here’s what sets us apart:

 Expert Regulatory Team – Deep knowledge of CDSCO norms and IVD classifications
 End-to-End Support – From product ideation to post-approval changes
 Custom-Tailored Solutions – Services aligned with your product and market goals
 Transparency & Timeliness – Regular updates, accurate filings, and timely approvals
 PAN India Reach – Strong network with central and state regulatory authorities

Whether you’re a start-up launching a new IVD kit, a multinational importing advanced diagnostics, or an established player expanding your product line, Rico Solutions delivers compliance, clarity, and confidence.

Get in Touch with Rico Solutions

Transform your regulatory process into a growth enabler. Partner with Rico Solutions India Private Limited for trusted guidance on all IVD-related licenses and registrations.