Medwisdom Lifescience provides end-to-end regulatory support for medical device manufacturers seeking Class A, B, C & D device approvals — from CDSCO registration to global submissions across 15+ countries.
Medwisdom Lifescience is a specialized medical device regulatory consultancy in India with deep expertise in navigating the complex landscape of CDSCO approvals, manufacturing licenses, and international market submissions. We serve medical device manufacturers, importers, and innovators across India and globally.
Our consultants bring more than two decades of combined experience across pharmaceuticals, in-vitro diagnostics, surgical instruments, and Class A–D medical devices. We understand every milestone in your regulatory journey — and we're committed to getting you there faster and with full compliance.
Whether you are a startup entering the Indian market or an established manufacturer seeking global expansion, our team provides strategic regulatory guidance, precise documentation, and proactive regulatory authority follow-ups tailored to your product and timeline.
Learn More About UsFrom initial classification to post-market surveillance, our regulatory services cover every stage of your medical device's lifecycle — ensuring full CDSCO and global compliance.
End-to-end registration support for Class A, B, C & D medical devices with the Central Drugs Standard Control Organisation (CDSCO), including dossier compilation and authority liaison.
Assistance in obtaining manufacturing licenses for all device classes from State Licensing Authorities (SLAs) and CDSCO, ensuring GMP compliance throughout the process.
Streamlined support for import license applications for foreign medical devices entering the Indian market, along with test license procurement for regulatory evaluation purposes.
Specialized regulatory services for IVD devices including reagents, diagnostic kits, and laboratory instruments — with performance evaluation report (PER) preparation and submission.
Preparation of complete medical device technical files for CDSCO submissions, including design documentation, risk analysis, biocompatibility data, and clinical evidence summaries.
Regulatory-compliant CER preparation using published literature, clinical investigations, and post-market clinical follow-up data — aligned with CDSCO and MDR/EU MDR requirements.
Customized regulatory roadmaps designed to expedite device approvals. We identify the fastest compliant pathway and align your submission strategy accordingly — saving you time and cost.
Review and optimization of device labelling, Instructions for Use (IFU), and promotional material to ensure full regulatory compliance with CDSCO labelling norms.
Thorough gap assessments of your existing technical documentation and quality systems against applicable regulatory standards, with actionable remediation recommendations.
Expert support for FDA 510(k) premarket notifications, CE marking under EU MDR, and regulatory submissions across North America, Europe, GCC countries, and the Asia-Pacific region.
Ongoing regulatory maintenance including adverse event reporting, vigilance reporting, device recalls, periodic safety update reports (PSURs), and regulatory renewal management.
Systematic risk management planning and pharmacovigilance frameworks integrated into your device's regulatory lifecycle to ensure patient safety and sustained market compliance.
Under the Medical Devices Rules, 2017, all medical devices in India are classified into four risk-based categories. Our consultants provide regulatory support across all classes.
| Device Class | Risk Level | Examples | Regulatory Authority | Our Support |
|---|---|---|---|---|
| Class A | Low Risk | Tongue depressors, examination gloves, bandages | State Licensing Authority (SLA) | Manufacturing & import license filing |
| Class B | Low-Moderate | Hypodermic needles, suction equipment, blood glucose monitors | SLA / CDSCO | Dossier preparation, SLA & CDSCO liaison |
| Class C | Moderate-High | Lung ventilators, bone fixation plates, dialysis machines | CDSCO | Technical file, CER, clinical data compilation |
| Class D | High Risk | Heart valves, implantable defibrillators, neurostimulators | CDSCO (Central) | Full regulatory strategy, clinical evaluation & submission |
Our proven 6-step regulatory process minimizes delays and maximizes your first-submission approval success rate.
We review your device, its intended use, and determine the correct CDSCO classification and applicable regulatory pathway.
We design a customized submission plan, identifying the fastest compliant route and timelines for your specific device class.
Our team compiles the complete technical file — design data, risk management, clinical evaluations, and labelling.
We prepare and submit your application to the appropriate regulatory authority (CDSCO or SLA) with precision and completeness.
We proactively track application status and handle all regulatory queries, deficiency responses, and clarification requests.
Upon approval, we provide post-market surveillance support, renewals, and variation management to maintain compliance.
We combine regulatory depth, global reach, and client-first communication to deliver approvals faster without compromising compliance quality.
In-depth knowledge of CDSCO, FDA, EU MDR, GCC, TGA, and other regulatory frameworks across 15+ markets.
Complete lifecycle coverage — from product classification and registration through to post-market surveillance and renewals.
High-quality regulatory consulting at transparent, competitive pricing — with no hidden fees and maximum ROI on your investment.
We prioritize accurate, complete first submissions to minimize back-and-forth and accelerate approval timelines.
Regular project updates, dedicated account managers, and responsive communication at every regulatory milestone.
100% compliance success rate across 100+ completed projects spanning pharmaceuticals, medical devices, and diagnostics.
Medwisdom's expertise in navigating medical device regulations has been invaluable to our operations. Their systematic approach to CDSCO registration reduced our approval timeline significantly. Highly recommended for any medical device company in India.
Their CTD compliance services for medical devices are excellent. The team delivers tailored regulatory solutions with remarkable efficiency and attention to detail. Our import license was obtained faster than expected.
Medwisdom is a top-tier choice for medical device regulatory services in India. They successfully guided us through complex Class C device registration with expert handling of all CDSCO queries. Professional, reliable, and highly knowledgeable.
Get answers to the most common questions about CDSCO medical device registration, licensing, and regulatory compliance in India.
The CDSCO medical device registration process in India involves device classification (Class A–D), preparation of a technical dossier including design documentation, risk management files, and clinical data, followed by online application submission through the SUGAM portal. Approval timelines vary by device class — Class A/B typically take 3–6 months, while Class C/D may require 12–18 months. Medwisdom's consultants manage every step of this process on your behalf.
As per the Medical Devices Rules, 2017, all four classes (A, B, C, and D) require regulatory authorization. Class A and B devices require a manufacturing or import license from the State Licensing Authority (SLA), while Class C and D devices require mandatory CDSCO approval at the central level. Our team supports all device classes across the registration spectrum.
Registration timelines depend on the device class and completeness of the submitted dossier. Class A and B devices can typically be registered within 3–6 months, Class C within 9–12 months, and Class D devices may take 12–24 months. Medwisdom's proactive regulatory strategy and complete first-submission approach help minimize delays and optimize approval speed.
Yes. We specialize in assisting overseas manufacturers in obtaining import licenses and CDSCO registration for their medical devices in India. This includes appointing an Indian authorized agent, preparing the technical file, conducting gap analysis against Indian regulatory requirements, and managing the CDSCO submission and follow-up process end-to-end.
Key documents typically include: device description and intended use, design and manufacturing information, risk management report (per ISO 14971), clinical evaluation report, performance evaluation data (for IVDs), labelling and IFU, quality management system certificate (ISO 13485), biocompatibility data, and country of origin regulatory approval (for imports). Medwisdom prepares and compiles all required documentation for you.
Yes. In addition to CDSCO submissions, Medwisdom supports global market entries including FDA 510(k) premarket notifications (USA), CE marking under EU MDR 2017/745 (Europe), TGA registration (Australia), Health Canada submissions, GCC country approvals (Saudi Arabia, UAE, Qatar), and more. We serve clients across 15+ countries.
Our post-approval services include license renewals, post-market surveillance (PMS) planning, adverse event reporting, vigilance reporting, regulatory variations for design or labelling changes, periodic safety update reports (PSURs), and ongoing regulatory compliance monitoring. We ensure your device remains continuously compliant throughout its market lifecycle.