Endorsement Services for Medical Devices & IVDs
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Endorsement Services for Medical Devices & IVDs – Rico Solutions India Private Limited
Rico Solutions India Private Limited stands as a reliable name in regulatory consulting for medical devices and in-vitro diagnostics (IVDs) in India. One of our specialized offerings includes comprehensive assistance in Endorsement services as per the regulatory framework defined by the Medical Device Rules, 2017 governed by the Central Drugs Standard Control Organization (CDSCO).
In the regulatory context, Endorsement refers to the process of adding or updating specific product details to an already approved license or certificate, ensuring that any new model, variant, or brand under an existing manufacturer or importer is legally covered under the Indian medical device regulations.
What is an Endorsement in Medical Device Licensing?
An Endorsement is typically required in the following scenarios:
- Adding a new product or model under an existing manufacturing or import license
- Including a new brand name or variant
- Expanding the product listing without obtaining a new license from scratch
- Regulatory compliance with post-approval product additions or changes
It is a cost-effective and faster alternative to applying for a new license and ensures seamless operations for manufacturers and importers alike.
Why Endorsement is Important
- Regulatory Compliance: You must ensure every product or variant being sold in India is included under a valid license.
- Avoid Legal Issues: Selling a product not endorsed on the original license can result in penalties or product recall.
- Simplifies Product Launches: For companies introducing new models or making slight modifications, endorsement is a streamlined way to stay compliant.
- Builds Credibility: Clients and partners prefer working with organizations that follow due regulatory diligence.
Types of Licenses Eligible for Endorsement
Rico Solutions assists in the endorsement of the following licenses:
- Medical Device Import License (Form MD-15)
- Medical Device Manufacturing License (Form MD-5 or MD-9)
- In Vitro Diagnostic (IVD) Device Import or Manufacturing Licenses
- Loan licenses (when applicable)
Documents Required for Endorsement
To proceed with an endorsement, the following documents are typically required:
- Cover Letter requesting endorsement
- Copy of the existing license (Form MD-5, MD-9, MD-15, etc.)
- Details of the product to be endorsed
- Product labels, artwork, and brand information
- Undertaking from the license holder
- Free Sale Certificate, wherever applicable (especially for imported devices)
- Technical dossier or product information as per CDSCO requirements
- Fees as per the applicable regulatory schedule
Our team helps you collect, validate, and organize these documents to minimize delays and rejection.
How Rico Solutions Helps You
With years of expertise in the Indian medical device regulatory ecosystem, we at Rico Solutions India Private Limited offer:
- End-to-end assistance in endorsement filing and submission
- Thorough document verification and dossier preparation
- Direct liaison with the CDSCO and state licensing authorities
- Handling queries, clarifications, or show-cause notices (if any)
- Follow-up until successful grant of the updated license
Our services are tailored to startups, MSMEs, multinational brands, and third-party manufacturers looking to navigate India’s complex regulatory landscape without risk.
Timeline for Endorsement
- Average time: 4-6 months (depending on the class of the device and documentation readiness)
- Expedited support is available for urgent or bulk endorsements
When Do You Need an Endorsement?
- Planning to launch a new product under the same brand
- Updating your existing product with new variants
- Expanding your portfolio in India without applying for a fresh license
- Adding more products under a loan license
Why Choose Rico Solutions India Private Limited?
100% Regulatory Compliance
Experienced team of regulatory experts and consultants
Timely submissions with real-time updates
Transparent pricing and process
PAN-India client base with global partnerships
Personalized support for each class of medical device and IVD
Contact Us Today
If you’re planning to expand your product line or include a new model under your existing license, reach out to Rico Solutions India Private Limited. We simplify your journey with CDSCO and ensure your endorsement process is handled smoothly and efficiently.