What Is an Endorsement in Medical Device Regulation?

Endorsement refers to the approval of specific changes, additions, or modifications in a medical device license. This may include adding new products under an existing license, updating product details, or revising technical documentation. Endorsements are a critical part of regulatory compliance, particularly when dealing with import licenses (Form MD-15) or manufacturing licenses (Form MD-5/MD-9).

Why Endorsement Is Important for Medical Device Companies?

Whether you’re a manufacturer or importer, staying compliant with the Drugs and Cosmetics Act, 1940 and the Medical Device Rules, 2017 is not optional. Endorsements play a key role in:

• Adding new models or variants to an existing license
• Modifying manufacturing sites, raw material sources, or specifications
• Updating labeling or technical documentation
• Ensuring legal distribution and marketing of modified or new versions
• Maintaining license validity and audit-readiness

Without proper endorsement, companies risk penalties, delays, and rejection of their products in the Indian market.

Our Endorsement Service Process

Rico Solutions India Private Limited streamlines the entire endorsement process, covering every detail from documentation to submission. Our process includes:

1. Assessment & Consultation:
   • We first evaluate your existing license and proposed change.
   • Expert advice is provided on whether the change qualifies for endorsement or requires a fresh application.
2. Documentation Preparation:
   • Compilation of technical data, declaration letters, labeling, product specifications, and certificates.
   • Preparation of covering letters and justification notes as per CDSCO format.
3. Online Application Filing:
   • Submission of endorsement application via the Sugam Portal or other relevant CDSCO platforms.
   • Use of authorized digital signatures and company credentials for a compliant submission.
4. Liaison with CDSCO:
   • Active follow-up with the CDSCO and State Licensing Authorities.
   • Clarification and resolution of queries raised by regulatory bodies.
5. Approval & Post-Endorsement Assistance:
   • Final endorsement certificate provided once approved.
   • Guidance on using the updated license for future regulatory interactions, audits, and product launches.

Types of Endorsements We Handle

At Rico Solutions, we assist in various types of endorsements including:

• Product Addition – Add a new device to an existing Form MD-15 or MD-5 license
• Change in Manufacturing Site – For imported or locally manufactured devices
• Design / Specification Updates – Any technical improvement or change in device structure
• Packaging & Labeling Updates – Compliance with new labeling requirements
• Legal Manufacturer Details – Endorsement in case of change in legal ownership, address, or contact info
• Brand Name Updates – Branding or trademark changes
• Shelf-Life or Storage Condition Updates

Who Needs Endorsement Services?

Our endorsement services are ideal for:

• Medical Device Importers
• Local Manufacturers of Class A to Class D Devices
• Authorized Indian Agents of Foreign Manufacturers
• Startups launching new devices
• Multinational companies updating regulatory filings in India

Whether you are expanding your portfolio or improving an existing device, Rico Solutions India Private Limited is your reliable regulatory partner.

Why Choose Rico Solutions for Endorsements?

Regulatory Expertise – Our team understands every clause of the Medical Device Rules, 2017.
End-to-End Support – From product strategy to CDSCO approvals.
Fast Turnaround Time – Minimize delays with efficient document preparation and submission.
Transparent Pricing – No hidden fees. Detailed cost breakdowns provided.
Dedicated Liaison Officers – Smooth interaction with regulatory authorities.
PAN India & Global Clients – Trusted by startups, MSMEs, and Fortune 500 companies.

Documentation Required for Endorsement

We help prepare all mandatory documents, including:

• Cover Letter
• Existing License Copy (MD-5/MD-9/MD-15)
• Details of the proposed change or addition
• Updated Product Information
• Undertaking by the authorized signatory
• Proof of payment (Government fees)
• Certificate of analysis (for changes in formulation)
• Updated IFU/Labels/Technical Files

Timelines & Government Fees

• Timeline: CDSCO approval for endorsements may take 2 to 4 weeks depending on the complexity of the case.
• Government Fee: Depends on the license class and nature of the endorsement (payable via Bharatkosh portal or as prescribed).

Partner with Us for Hassle-Free Endorsement Filing

Avoid the pitfalls of regulatory delays and compliance lapses. With Rico Solutions India Private Limited, get professional guidance, accurate documentation, and timely updates on your endorsement applications. We ensure your device remains market-ready while complying with Indian regulatory standards.