Medical Device Manufacturing License

Manufacturing a medical device in India requires strict compliance with the Medical Device Rules (MDR), 2017, as regulated by the Central Drugs Standard Control Organization (CDSCO). Rico Solutions India Private Limited helps you obtain your Medical Device Manufacturing License (Form MD-5 and MD-6) for all device classes (A, B, C, D).

Our team facilitates:

• Classification and grouping of medical devices
• Site compliance as per Schedule IV
• Preparation of technical documents and device master files
• Audit coordination and application filing via the CDSCO SUGAM portal
• Liaison with State Licensing Authorities (SLA) for Class A and B
• Support in acquiring QMS certifications like ISO 13485

Whether you’re a start-up or an established manufacturer, we streamline the entire process for faster approvals and long-term compliance.

Medical Device Import License

India’s growing medical technology market offers vast potential for global players. To import medical devices, companies must comply with MDR 2017 and obtain Import Licenses (Form MD-14 and MD-15) from CDSCO.

Rico Solutions India Private Limited ensures hassle-free licensing by:

• Verifying product classification and risk-based grouping
• Preparing Device Master Files (DMF) and Plant Master Files (PMF)
• Collating Free Sale Certificates (FSC), ISO certifications, and regulatory approvals from countries like the USA (FDA), EU (CE), Australia (TGA), etc.
• Guiding through the SUGAM portal application
• Coordinating with CDSCO for clarifications or document deficiencies

We help both Indian agents and foreign manufacturers fulfill all mandatory regulatory requirements to bring advanced healthcare solutions into the Indian market efficiently.

Post Approval Change (PAC)

Regulatory obligations don’t end at approval. Manufacturers and importers must report any Post Approval Changes (PAC) to CDSCO to maintain the validity of their licenses. These changes may include updates in manufacturing sites, device composition, labeling, packaging, shelf life, indications, or even changes in authorized Indian agents.

Rico Solutions India Private Limited offers expert assistance in:

• Assessing the type of change (major/minor)
• Preparing impact assessments and justification reports
• Filing PAC applications in prescribed forms (e.g., MD-16 for importers, MD-7 for manufacturers)
• Follow-up and coordination with regulatory bodies

Our approach ensures timely compliance and avoids potential disruptions in licensing continuity or market access.

Test License for Import/Manufacturing

Medical device innovation often requires clinical testing, validation, and demonstration, which in turn necessitates a Test License for Import or Manufacturing (Form MD-16/MD-17). These licenses allow entities to import or manufacture medical devices not yet registered in India for purposes like clinical investigations, performance evaluations, demonstrations, or training.

Rico Solutions India Private Limited facilitates:

• Identification of device category and type of testing required
• Drafting and submission of required documents including protocols, site details, and end-use declarations
• Liaison with CDSCO for test license approvals
• Ensuring compliance with applicable ISO standards and safety norms

We simplify the process so that innovators can conduct necessary trials and validations without regulatory delays.

Endorsement Services

In India, the addition of new devices to an existing license requires proper endorsement by CDSCO or SLA. Failing to update your license with newly introduced SKUs, variants, or product families may result in regulatory non-compliance.

Rico Solutions India Private Limited helps with:

• Updating and modifying Form MD-5/MD-6 or MD-15/MD-16 to include additional products
• Submitting revised Device Master Files and supporting documents
• Coordination with authorities for approval and license re-issuance
• Verifying that all endorsements align with ISO 13485, IEC 60601, and MDR standards

Stay ahead of compliance risks with Rico’s expert endorsement solutions that keep your licenses updated and your portfolio growing.

Class A NSNM Registration

Low-risk Class A Non-Sterile, Non-Measuring (NSNM) devices now require registration under MDR 2017, making compliance a priority even for seemingly simple devices. Examples include thermometers (non-digital), tongue depressors, cotton rolls, and more.

Rico Solutions India Private Limited supports Class A NSNM manufacturers and importers by:

• Ensuring correct product classification as NSNM
• Registering devices via the CDSCO’s online portal
• Assisting with labeling, UDI requirements, and documentation
• Advising on exemption categories and compliance timelines

Our Class A NSNM service ensures you stay compliant without hassle, enabling smooth business operations without regulatory bottlenecks.

Why Choose Rico Solutions India Private Limited?

Expert Regulatory Knowledge
Our specialists stay updated on CDSCO, BIS, ISO, and international standards to guide you through complex medical device regulations.

End-to-End Licensing Support
From initial consultation to license issuance, we handle every step of the regulatory process for both Indian and foreign manufacturers.

Time-Efficient Solutions
We value your time. Our streamlined workflows ensure quicker submissions, fewer queries, and timely approvals.

Transparent Process & Documentation
No hidden steps or confusing procedures – we ensure you understand what’s being done and why at every stage.

Post-License Compliance
Our job doesn’t end at license approval. We provide annual return filing, license renewals, PAC updates, and post-market surveillance support.

Our Clients

We proudly serve:

• Startups entering the MedTech space
• Global medical device brands expanding into India
• Hospitals and diagnostics labs
• Distributors and authorized Indian agents
• OEMs and white-label manufacturers

Whether you are developing an innovative wearable, importing surgical equipment, or manufacturing disposable diagnostic devices – Rico Solutions India Private Limited ensures you meet all CDSCO and MDR 2017 norms.

Let’s Make Compliance Easy

At Rico Solutions India Private Limited, we believe that regulatory compliance should empower innovation – not slow it down. With a team of skilled regulatory experts and a deep understanding of India’s medical device landscape, we help you unlock opportunities while staying 100% compliant.

Contact Us Today
For a consultation or to get started with your medical device license, reach out to Rico Solutions India Private Limited