Who We Are

Rico Solutions India Private Limited is a leading regulatory consultancy and compliance support firm committed to helping manufacturers, importers, and startups in the medical device sector navigate the Indian regulatory landscape with ease. With a sharp focus on accuracy, timelines, and client success, we bring in-depth knowledge of regulatory policies and a client-centric approach to ensure that your medical devices reach the Indian market smoothly and compliantly.

Our specialized services include:

• Medical Device Import License
• Medical Device Manufacturing License
• Post Approval Change Applications
• Test License for Import and Manufacturing
• License Endorsement
• Class A Non-Sterile Non-Measuring (NSNM) Registration

Whether you are a domestic manufacturer or an international brand looking to enter the Indian market, Rico Solutions India Private Limited is your one-stop partner for all regulatory and licensing requirements.

1. Medical Device Import License

Importing medical devices into India requires an Import License under the Medical Device Rules, 2017. Whether your devices fall under Class A, B, C, or D, Rico Solutions helps you obtain the CDSCO Medical Device Import License in a systematic and hassle-free manner.

We provide:

• End-to-end dossier preparation (Form MD-14/MD-15)
• Device classification support
• Coordination with Indian Authorized Agent (if applicable)
• Regulatory gap analysis
• Query resolution with CDSCO
• Post-submission monitoring and license issuance

Our team ensures that all documents, including Free Sale Certificates (FSC), CE certification, ISO 13485, and labeling information, are in full compliance with the CDSCO norms.

2. Medical Device Manufacturing License

If you’re a manufacturer looking to produce medical devices in India, obtaining a Medical Device Manufacturing License is a legal requirement. Rico Solutions assists you in acquiring both Form MD-5 (for Class A and B devices) and Form MD-9 (for Class C and D devices).

Our services cover:

• Plant audit preparation
• Technical documentation support
• QMS (Quality Management System) implementation assistance
• Site Master File (SMF) preparation
• Device Master File (DMF) documentation
• Liaising with State Licensing Authorities (SLA) or CDSCO

With us, you can confidently establish your manufacturing unit and focus on product innovation, while we take care of compliance and approvals.

3. Post Approval Change Applications

Medical devices evolve with time through improvements in design, labeling, manufacturing process, or intended use. Such changes after license issuance require regulatory approval known as Post Approval Change (PAC).

Rico Solutions India Private Limited offers:

• Change categorization (Major or Minor)
• Dossier amendment support
• Risk assessment and impact analysis
• PAC submission and tracking with CDSCO
• Follow-ups for timely approval

We help ensure that your modified devices stay legally marketed in India without any regulatory hiccups, avoiding non-compliance risks and business disruptions.

4. Test License for Import and Manufacturing

If you are planning clinical evaluations or testing before commercial launch, obtaining a Test License is essential. Rico Solutions helps clients obtain:

• Test License for Import (Form MD-16/MD-17)
• Test License for Manufacturing (Form MD-12/MD-13)

These licenses are mandatory for performance evaluation, R&D, or clinical investigations.

Our support includes:

• Preparing test protocols
• Application filing
• Coordination with test labs or clinical trial sites
• CDSCO representation

We understand the urgency in R&D timelines and ensure prompt test license issuance so your project deadlines stay on track.

5. Endorsement Services

When a company adds new products under an existing license or modifies product details (brand name, model, shelf life, etc.), endorsement becomes necessary. Rico Solutions offers seamless endorsement services with a clear understanding of CDSCO formats and procedures.

Our process includes:

• Drafting endorsement letters
• New product classification
• Document collation
• Online application filing on CDSCO SUGAM portal
• Liaising with licensing authorities

Whether it’s an import or manufacturing license, we ensure that endorsements are updated in official records promptly, allowing you to expand your product portfolio without delay.

6. Class A NSNM Registration

For low-risk devices that are Non-Sterile and Non-Measuring (NSNM) under Class A category, registration is straightforward but mandatory.

Rico Solutions provides a turnkey solution for Class A NSNM Device Registration, which includes:

• Product classification validation
• Online registration through CDSCO portal
• Preparation of Form MD-1 and MD-2
• QMS support as per ISO 13485 or equivalent
• Liaising with State Licensing Authorities

Our expertise ensures that your low-risk devices can be legally manufactured or marketed in India with minimum regulatory burden and full compliance.

Why Choose Rico Solutions India Private Limited?

1. Regulatory Expertise:
   Our team comprises regulatory professionals, biomedical engineers, compliance analysts, and ex-CDSCO consultants with vast domain knowledge.
2. 100% Compliance Track Record:
   We have successfully handled more than 500+ medical device license applications with zero rejections due to documentation errors.
3. Fast Turnaround:
   We value your time. Our streamlined internal processes and excellent rapport with regulatory authorities ensure that you get your licenses faster.
4. Confidentiality and Integrity:
   Client confidentiality and ethical handling of sensitive product data are at the core of our operations.
5. Affordable Pricing:
   We offer high-value services at competitive pricing, suitable for startups, MSMEs, and large enterprises alike.

Our Clients

We have served:

• Indian startups developing affordable diagnostic kits
• Global medical device brands entering the Indian market
• OEM manufacturers for Class A/B devices
• Healthcare entrepreneurs launching niche surgical instruments
• Academic institutions and R&D labs needing test licenses

Rico Solutions is proud to be the silent regulatory partner behind many successful medical device launches in India.

Final Thoughts

Navigating India’s medical device regulatory framework is complex, but not when you have the right partner. Rico Solutions India Private Limited is your dependable ally in achieving fast, compliant, and stress-free licensing and registration. From import to manufacturing, post-approval modifications to product testing, we take the burden off your shoulders, allowing you to focus on what you do best—building quality healthcare solutions.

For consultation, service inquiries, or collaboration opportunities, get in touch with us today.

Rico Solutions India Private Limited
Your Regulatory Partner in Medical Device Licensing