What is an In Vitro Diagnostic Manufacturing License?

An In Vitro Diagnostic (IVD) Manufacturing License is a statutory requirement for any company intending to manufacture IVD products in India. These licenses are issued by the Central Licensing Authority (CLA) or the State Licensing Authority (SLA) based on the risk classification of the devices (Class A, B, C, or D).

The license certifies that the manufacturer meets the required standards for infrastructure, personnel, quality management systems, and product safety as defined under the MDR, 2017.

Why Choose Rico Solutions for IVD Manufacturing License Assistance?

Rico Solutions India Private Limited brings you:

• Comprehensive Regulatory Support
  From documentation to regulatory filings, we handle the end-to-end process.
• Class-Based Licensing Expertise
  Whether your IVD device falls under Class A (low risk) or Class D (high risk), we tailor our strategy to your product category.
• Personalized Consultation
  We evaluate your infrastructure, documentation, and internal quality systems to advise you on compliance readiness.
• Audit Preparation and Training
  Our experts help you prepare for CDSCO or SLA inspections through training, mock audits, and quality gap analysis.
• Time-Saving and Cost-Effective Process
  We ensure faster application turnaround, reducing back-and-forth with authorities and helping you launch faster.

Regulatory Framework in India

In India, IVD devices are regulated under the Medical Device Rules, 2017, which came into force under the Drugs and Cosmetics Act, 1940. All manufacturers must comply with:

• Schedule M-III: Good Manufacturing Practices (GMP)
• ISO 13485 certification
• Specific guidelines for quality control, storage, and labeling
• Site inspection and approval from SLA or CLA depending on the class of IVD

Classes of IVD Devices & Licensing Authorities

• Class A & B (Low to Moderate Risk)
  License granted by State Licensing Authority (SLA)
• Class C & D (Moderate to High Risk)
  License granted by Central Licensing Authority (CDSCO)

We help manufacturers determine the correct class and corresponding authority for their specific product types.

Step-by-Step Licensing Process We Handle

1. Product Classification and Scope Finalization
   We assist in identifying and categorizing your IVD devices based on risk level and functionality.
2. Infrastructure Readiness Check
   Our team audits your manufacturing site for compliance with facility requirements under GMP and ISO 13485.
3. Documentation Compilation
   • Device Master File (DMF)
   • Plant Master File (PMF)
   • Quality manuals and SOPs
   • Labels, IFU (Instructions for Use), product design documentation
4. Application Filing on CDSCO SUGAM Portal
   We handle the complete online submission process through India’s regulatory platform.
5. Fee Payment and Form Submission
   Based on the device class, we submit Form MD-3 (Class A/B) or Form MD-7 (Class C/D).
6. Inspection Coordination
   We coordinate with licensing authorities and facilitate site inspections or audits.
7. Post-Audit Compliance
   Any observations raised by the licensing authorities are addressed promptly with corrective actions.
8. License Grant and Renewal
   Upon successful review, you will receive your IVD Manufacturing License (MD-5 for Class A/B or MD-9 for Class C/D). We also support license renewals and amendments.

Types of IVD Products Covered

We assist in licensing for various IVD product categories including:

• Clinical chemistry analyzers
• Immunoassay systems
• Hematology instruments
• Rapid test kits (HIV, malaria, dengue, etc.)
• COVID-19 diagnostics
• Urine analysis kits
• Blood glucose monitoring systems
• Pregnancy test kits

Whether you are a new manufacturer or expanding into new product lines, Rico Solutions provides tailored solutions for all categories.

Key Documents Required

To apply for an IVD Manufacturing License, the following are typically required:

• Site layout and plant blueprint
• Valid ISO 13485 certificate
• List of equipment and instruments
• SOPs and quality policy
• Details of manufacturing staff (qualifications & experience)
• Environmental monitoring data
• Product labels, brochures, and technical files

We ensure that all these documents are compiled and reviewed before submission to avoid delays.

Additional Services from Rico Solutions

• Post Approval Change Management
  Whether it’s a change in address, technical personnel, or manufacturing process, we help update your license smoothly.
• Test License for R&D or Validation
  Need to test IVD products before full-scale manufacturing? We help you apply for test manufacturing licenses.
• Import of Raw Materials for IVD
  Assistance in applying for Import Licenses for raw materials or analyzers used in the production of IVD kits.
• License Endorsements
  If you’re adding new products to your existing license, we handle the endorsement process seamlessly.
• Class A NSNM Registration
  We also help register non-sterile, non-measuring IVDs under Class A where licensing is not mandatory but voluntary registration is encouraged.

Who Should Approach Us?

Our services are ideal for:

• Startups entering the IVD manufacturing market
• Existing pharma companies diversifying into diagnostics
• Contract manufacturers (OEM/ODM)
• Hospitals and labs setting up diagnostic manufacturing units
• Importers transitioning to local manufacturing under “Make in India”

Why Regulatory Compliance is Crucial

Failure to obtain a valid manufacturing license can lead to:

• Legal penalties and prosecution under the Drugs & Cosmetics Act
• Product recalls and brand reputation damage
• Export barriers due to lack of regulatory certification
• Loss of business and customer trust

Avoid these pitfalls by partnering with Rico Solutions — your trusted regulatory ally.

About Rico Solutions India Private Limited

Rico Solutions India Private Limited is a leading regulatory consultancy and compliance service provider specializing in medical devices and diagnostics. Our experienced team of professionals, former regulators, and subject matter experts offer:

• 360° support from registration to licensing and audits
• In-depth knowledge of Indian and global regulatory frameworks
• Transparent, ethical, and time-bound processes
• Pan-India service coverage

We take pride in being one of the most trusted names in the medical device and IVD regulatory sector.

Final Thoughts

The IVD market in India is rapidly evolving and full of opportunity. Whether you’re manufacturing rapid test kits or complex analyzers, your first step is to become compliant with the law. Let Rico Solutions India Private Limited be your strategic partner in obtaining your In Vitro Diagnostic Manufacturing License — efficiently, ethically, and effectively.

Your success in the diagnostics industry starts with the right license. And your license starts with Rico.