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Supporting Medical Device Companies in Achieving Regulatory Approval and Market Access in India
Empowering Compliance for India’s MedTech Growth
MedReg Consultancy helps medical device manufacturers navigate Europe’s complex regulatory landscape with ease. From CE certification and ISO 13485:2016 compliance to technical documentation, clinical evaluations, and post-market surveillance, we simplify every stage to keep your products compliant, competitive, and ready for market growth.
Services We Offer in India
As a premier regulatory solutions provider, we help medical device manufacturers navigate the Indian market with these services.
Manufacturing License
Obtaining a manufacturing license in India is essential for medical device companies Seeking compliance and market access. At MedReg Consultancy, we streamline the entire process, from documentation and regulatory submissions to audits and approvals, helping to secure licenses quickly and confidently.
Import License
An import license is mandatory for bringing medical devices into the Indian market, ensuring compliance with CDSCO regulations. At MedReg Consultancy, we simplify the process by managing documentation, regulatory submissions, and approvals, enabling manufacturers to access India’s market efficiently and without delays.
Clinical Trails
Clinical trials are a crucial step in demonstrating the safety and effectiveness of medical devices before market approval. At MedReg Consultancy, we assist in end-to-end trial management, protocol design, regulatory approvals, site selection, monitoring, and reporting, ensuring compliance with Indian and global standards.
Free Sale Certificate
A Free Sale Certificate (FSC) is an essential document that confirms medical devices are legally sold and freely available in the Indian market, making it a prerequisite for exports. At MedReg Consultancy, we assist manufacturers in obtaining FSCs by managing the complete application and documentation process, ensuring smooth and timely approvals for global market access.
Product Endorsement
Product endorsement from regulatory authorities validates the safety, quality, and compliance of your medical device, building trust and credibility in the market. At MedReg Consultancy, we support you through the endorsement process with precise documentation, regulatory submissions, and expert guidance to help your product gain approval seamlessly.
Retention of License
Retention of a license is a mandatory requirement to keep your medical device manufacturing or import license valid in India. At MedReg Consultancy, we manage the Entire retention process, tracking deadlines, preparing documentation, and handling submissions, ensuring uninterrupted compliance and seamless market access for your business.
Market Standing Certificate
A Market Standing Certificate (MSC) demonstrates that your medical device has been legally sold and is in good standing in the Indian market, Enhancing credibility for exports and regulatory approvals. At MedReg Consultancy, we assist with the complete MSC process, from documentation to submission, ensuring smooth and timely certification.
Non-conviction Certificate
A Non-Conviction Certificate (NCC) confirms that a medical device manufacturer or importer has a clean compliance record with no regulatory violations And is often required for licenses and approvals. At MedReg Consultancy, we guide you through the entire NCC process, preparing documentation, coordinating with authorities, and ensuring timely issuance for seamless regulatory compliance.
Labeling Review
Accurate and compliant labelling is critical for medical devices to meet regulatory standards and ensure patient safety. At MedReg Consultancy, we review and validate your product labels, Including content, language, symbols, and regulatory requirements, helping you achieve full compliance and market readiness.
Product Development
Successful medical device product development requires regulatory compliance at every stage. At MedReg Consultancy, we support you from concept to launch, assisting with design, documentation, risk assessment, and regulatory approvals, to ensure your product meets all Indian and international standards efficiently and safely.
Authorized Agent
An Authorised Agent acts as a regulatory liaison between medical device manufacturers and Indian authorities, ensuring compliance and smooth approvals. At MedReg Consultancy, we serve as your trusted Authorised Agent, Managing submissions, correspondence, and regulatory requirements to streamline your market entry ensure ongoing compliance in India.
Wholesale License
A wholesale license is mandatory for distributing medical devices across India, ensuring compliance with CDSCO regulations and legal standards. At MedReg Consultancy, we guide you through the entire licensing process, from documentation and submissions to approvals, helping you start or expand your distribution network seamlessly and compliantly.
Sterilization Process Validation
Sterilisation process validation ensures that medical devices are safely and effectively sterilised, meeting all regulatory and quality standards. At MedReg Consultancy, we assist you with validation planning, execution, documentation, and regulatory compliance, ensuring your devices are safe, reliable, and market-ready.
QMS Documentation
A robust Quality Management System (QMS) is essential for regulatory compliance and consistent product quality. At MedReg Consultancy, we help medical device manufacturers develop, organise, and maintain QMS documentation, including SOPs, manuals, and records, ensuring full compliance with ISO 13485 and other regulatory standards.
AMC – Annual Maintenance contract services for documentation
Our Annual Maintenance Contract (AMC) services ensure your regulatory documentation remains up-to-date, compliant, and audit-ready throughout the year. At MedReg Consultancy, we manage regular updates, reviews, and regulatory changes, helping you maintain seamless compliance without interruptions.
Device master File Preparation
A Device Master File (DMF) is essential for documenting the design, manufacturing, and quality processes of a medical device. At MedReg Consultancy, we assist in preparing comprehensive DMFs, that cover all technical and regulatory requirements, ensuring smooth approvals and regulatory compliance in India and abroad.
Voluntary Registration
Voluntary registration allows medical device manufacturers to proactively align with regulatory standards, demonstrating product safety and quality. At MedReg Consultancy, we assist you throughout the registration process , preparing documentation, submitting applications, and ensuring compliance, helping you gain credibility and market confidence in India.
Neutral Code
A Neutral Code is a unique identifier assigned to medical devices for regulatory tracking and compliance purposes. At MedReg Consultancy, we assist manufacturers in obtaining and managing Neutral Codes, ensuring accurate product identification and smooth regulatory approvals in India.
Internal Audit
Internal audits are essential for assessing compliance, identifying gaps, and ensuring your quality management system meets regulatory standards. At MedReg Consultancy, we conduct thorough internal audits for medical device manufacturers, providing actionable insights and guidance to strengthen processes and maintain full compliance.
Certification Success, Without the Stress
Why Choose Medreg
Expert consultants, thorough regulatory insight, and a seamless path to compliance, that’s our promise for your medical devices.
Focused on Your Goals
Your challenges guide our approach. By actively listening, we design focused strategies that deliver measurable, result-driven outcomes.
Simplifying Complexity
We decode Complex regulatory requirements and define a clear, actionable pathway, to ensure your projects move forward efficiently and compliantly.
Comprehensive Understanding
We dive deep into your requirements, identifying all critical factors to ensure our solutions address every aspect of your regulatory needs.
Documentation You Can Trust
As experts, we provide clear, accurate, and accessible documentation, keeping you informed at every stage of your project.
Number speaks everything
Our numbers tell a story of growth, trust, and proven success. Every result reflects our expertise, commitment, and measurable impact.
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Compliance Made Simple–Start with a Free Consultation
Get the Answers You Need to Move Forward
Navigating medical device regulations doesn’t have to be overwhelming. At MedReg Consultancy, we’ve compiled answers to the most common client questions to guide you quickly through our services and how we can support your compliance journey. From emerging startups to established global players, our FAQs are your first stop. Need personalized help? We’re just a message away!
We provide end-to-end regulatory solutions for medical device manufacturers in India, including licensing, certifications, documentation, audits, and compliance support enabling access to both domestic and international market access.
Our services cover CDSCO licenses (MD-5, MD-6, MD-9, MD-10, MD-15), ISO 13485:2016, ICMED, Free Sale Certificates, Manufacturing and Import Licenses, Product Endorsements, Market Standing Certificates, Non-Conviction Certificates, and more.
Yes! We work with both emerging startups and established global manufacturers, providing tailored regulatory guidance and strategies to ensure smooth compliance and faster approvals.
We manage the complete process, from documentation and submissions to audits and approvals, helping you obtain licenses efficiently and remain compliant with Indian regulations.
Yes! We handle end-to-end clinical trial management, including protocol design, regulatory approvals, site selection, monitoring, and reporting, from documentation and submissions to audits and approvals with Indian and global standards.