Medical Device Classification
We identify the correct device class (A, B, C, or D) based on intended use and potential risk, ensuring precise regulatory compliance with MDR 2017 and CDSCO guidelines from the outset.
End-to-end regulatory support for CDSCO medical device registration — from device classification and technical documentation to SUGAM portal submission and market authorization for Class A, B, C & D devices.
We provide complete end-to-end support for CDSCO medical device registration — from initial classification and technical documentation to securing your registration certificate for market access.
We identify the correct device class (A, B, C, or D) based on intended use and potential risk, ensuring precise regulatory compliance with MDR 2017 and CDSCO guidelines from the outset.
Preparation of comprehensive technical dossiers covering manufacturing processes, quality documentation, process controls, and device safety — fully aligned with CDSCO requirements for all device classes.
Preparation of robust clinical and non-clinical evaluation reports for all device classes, including IVD devices, demonstrating safety and performance to meet CDSCO's scientific review standards.
ISO 13485 compliance is a mandatory prerequisite for registration in India. Our experts provide hands-on guidance to prepare your quality management system for regulatory audit, reducing gaps and delays.
We manage complete dossier submission to the Central Drugs Standard Control Organisation (CDSCO), including SUGAM portal filing, document coordination, and proactive follow-up for timely approvals.
We guide you through the final stages of obtaining your CDSCO registration certificate, enabling lawful market access without unnecessary delays and ensuring your product reaches patients on schedule.
As a recognized regulatory partner, we simplify every aspect of CDSCO compliance — from device registration and master file preparation to licensing and portal submissions.
End-to-end management of registration for all device categories — diagnostic devices, surgical instruments, implants, and IVD devices — ensuring timely and compliant market authorization from CDSCO.
Preparation of Device Master Files and Plant Master Files in the format required by CDSCO, accurately documenting all manufacturing and product information for efficient regulatory review and approval.
Expert assistance with SUGAM portal registration, accurate data entry, document uploads, and full compliance with portal-specific requirements for smooth, error-free CDSCO application processing.
Full support for manufacturing license applications — including documentation preparation, facility compliance guidance, and coordination with state drug authorities and CDSCO for timely license grant.
Comprehensive import license support for overseas manufacturers seeking to enter the Indian market — managing all documentation requirements in full compliance with CDSCO regulations and MDR 2017.
Assistance obtaining test licenses for R&D or investigational devices, enabling manufacturers to conduct performance evaluation and testing in India in full compliance with CDSCO requirements before full registration.
A trusted regulatory partner that combines official authorization, technical depth, and a results-driven approach to bring your device to market efficiently and compliantly.
We are an officially recognized authorized agent for medical device registration in India, legally empowered to represent both domestic and foreign manufacturers before CDSCO — ensuring fully accountable and compliant regulatory representation at every step.
Our team holds in-depth knowledge of Indian regulatory frameworks (MDR 2017, CDSCO guidelines) alongside international standards including ISO 13485, IEC 62304, CE marking, and US FDA — enabling seamless domestic and global market access strategies.
Our systematic, milestone-driven registration approach ensures your dossier is complete and compliant from the start — minimising queries, avoiding costly delays, and accelerating your time to market so life-improving devices reach patients sooner.
Client Testimonials
⭐⭐⭐⭐⭐ "Medwisdom's regulatory team guided us through CDSCO registration seamlessly. Their expertise in MDR 2017 compliance saved us months of back-and-forth with the authorities."
— Regulatory Manager, Medical Device Manufacturer | [Add verified client testimonials here]
Find clear, expert answers to the most common questions about CDSCO registration requirements, timelines, and documentation.
Medical device registration is a legal requirement under India's Medical Devices Rules (MDR) 2017 and is essential for the following reasons:
Medwisdom Lifescience guides manufacturers through every step to ensure full compliance and timely market access.
Required documents vary by device class but generally include:
Our team prepares and compiles all required documents to ensure a complete, compliant CDSCO submission.
Registration timelines depend on device class and submission quality:
Timelines are significantly influenced by the completeness and quality of the submitted dossier. Our thorough preparation approach minimises CDSCO queries and avoids preventable delays.
Yes. Foreign manufacturers can register their medical devices in India through CDSCO. Key requirements include:
As an authorized agent in India, Medwisdom Lifescience provides complete support to foreign manufacturers for all required CDSCO licenses and registrations.
Get personalized guidance on your CDSCO registration strategy, required documentation, and expected timeline — at no cost.
Request Free Consultation 📞 +91-9264127040 ✉ Info@medwisdom.in