CDSCO Registration for Medical Devices
Get expert help with CDSCO Registration for Medical Devices, CDSCO import license, and CDSCO registration certificate — fast, accurate, and with a high first-time approval rate. From medical devices to diagnostics, cosmetics to food — we handle every regulation, so you can focus on your business.
India's One-Point Solution for Regulatory Compliance
TraccGlobal is a Gurugram-based regulatory consultancy that has been helping manufacturers, importers, startups, and global companies navigate India’s complex health-product regulations for over a decade. We are deep specialists — not a generic firm.
Whether you need a CDSCO consultant for medical device registration, a CDSCO import license for diagnostic kits, cosmetic CDSCO certification, FSSAI licensing, or a complete turnkey factory setup — TraccGlobal handles it all under one roof with one dedicated team.
We are your one-point solution. 200+ businesses across India and globally trust us because we deliver results — not excuses. 98% first-attempt approval rate. 48-hour query resolution. Zero-error dossiers. Every time.
Medical Devices
CDSCO registration, import & manufacturing license under MDR 2017 — Class A, B, C, D.
IVD Diagnostics
Notified & non-notified kit registration, import & test licenses, performance evaluations.
Cosmetics
CDSCO cosmetic import registration under Schedule S with full INCI compliance support.
Food & FSSAI
FSSAI licensing, Schedule IV, FSS Food Product Standards & labeling compliance.
Global Certifications
ISO 13485, CE marking, USFDA 510(k), WHO PQ, and device registration across 20+ countries including USA, UK, Thailand, Vietnam.
Pharmaceutical Consultancy
Complete pharma consultancy for project setup, compliance, licenses, GMP certifications, and DPR preparation.
Vision, Mission & Core Values
Everything we do at TraccGlobal is driven by a single purpose — to make regulatory compliance simpler, faster, and stress-free for every business in India and beyond.
Our Vision
To be India’s most trusted partner and industry leader in regulatory consultancy for the healthcare and medical device sector — driving innovation, ensuring compliance, and contributing to the advancement of healthcare worldwide. We envision a world where no quality product fails to reach patients because of avoidable regulatory barriers.
Our Mission
To be India’s most trusted partner and industry leader in regulatory consultancy for the healthcare and medical device sector — driving innovation, ensuring compliance, and contributing to the advancement of healthcare worldwide. We envision a world where no quality product fails to reach patients because of avoidable regulatory barriers.
Speed
48-hour query resolution. Faster approvals than the industry average — every single time.
Precision
Zero-error documentation. 98% first-attempt CDSCO approval rate. No rejections, no rework.
Partnership
A named expert assigned to you personally. We grow when you grow. Long-term relationship, not just a transaction.
Global Reach
India-first regulatory expertise, serving clients from 20+ countries across Asia, Europe, and North America.
TraccGlobal interactive regulatory journey — explore four process stages and five services
Your regulatory journey, mapped
From first conversation to post-market compliance. Tap any stage to explore what we do for you.
Your regulatory journey, mapped
From first conversation to post-market compliance. Tap any stage to explore what we do for you.
We begin by understanding your product, your market ambitions, and the regulatory landscape you’re entering. No assumptions — every engagement starts with deep listening and targeted discovery to map the exact path forward.
We audit the current technology environment — comparable approved products, existing classifications, and precedent submissions. This ensures your dossier speaks the language regulators expect and anticipates their questions before they’re asked.
Using discovery and landscape insights, we architect a custom regulatory strategy. This is the blueprint — detailing the documentation package, testing requirements, timeline, and budget needed to get your product approved in India.
Strategy becomes execution. We assign a dedicated project manager, kick off documentation, and establish clear milestones. You get full visibility at every step — without needing to manage the process yourself.
Analyse the business needs
Review the technology landscape
Conceptualize the new requirements
Initiate project management
Everything You Need — Under One Roof
From CDSCO certification and medical device registration to factory setup and global market entry — TraccGlobal is India’s most comprehensive regulatory consultancy. 9 specialised services. One expert team.
CDSCO Regulatory Services
India's most experienced CDSCO consultant. We handle medical device registration (Class A–D), CDSCO import license, CDSCO registration certificate, IVD kit registration, cosmetic CDSCO certification, overseas manufacturer registration, SUGAM portal submissions, Form MD-14/MD-15 preparation, and all query resolution. 500+ approvals delivered.
Quality Management System (QMS)
A robust QMS is mandatory for CDSCO approval and global certifications. We build, implement, and certify QMS aligned with ISO 13485 and MDR requirements — including gap assessment & remediation, QMS setup, Quality Manual, SOPs, FMEA & risk management, complaint management, data integrity, and manufacturing compliance oversight.
Turnkey Project Services
End-to-end turnkey support for new manufacturing facilities — plant layout finalisation, HVAC/AHU designing & qualification, process setup, utility optimisation, ISO certification, greenfield factory consultancy, regulatory coordination, competent manpower placement, and Detailed Project Report (DPR) Preparation. From concept to operational facility.
Subject Matter Expert (SME)
Engage TraccGlobal's Subject Matter Experts for product design & development, evaluation & testing, regulatory training, process optimisation & lean manufacturing, product risk assessment (ISO 14971), technology transfer & batch scale-up, and troubleshooting complex compliance problems. Deep expertise, tailored solutions.
Product Services
Beyond consulting, TraccGlobal provides customised reagents and raw materials for medical device and diagnostic applications — tailored to specific research needs, defined chemical properties, purity specifications, and exact customer quality standards. Manufactured or sourced to your requirements.
Global Regulatory Certifications
Expand beyond India with CE marking (EU MDR), USFDA 510(k) & FDA registration, WHO Prequalification, and device registration across Thailand, Vietnam, UK, USA, and 20+ countries. We also handle WHO PQ compliance, global dossier & DMF preparation, and local authority submissions worldwide.
Food Regulatory Compliance (FSSAI)
FSSAI is India's apex food regulator — compliance is mandatory under FSSA 2006 & FSSR 2011. TraccGlobal provides FSSAI licensing & registration, Schedule IV implementation, product compliance per FSS Food Products Standards & Food Additives Regulation, and labeling compliance under Packaging & Labeling Regulations.
Design, Software & Development
Structured design and development services — feasibility studies, design documentation, risk analysis (ISO 14971), verification & validation (V&V) support, Design History File (DHF) preparation, and regulatory-aligned software development for Software as a Medical Device (SaMD) under IEC 62304.
Regulatory Training Programs
Customised regulatory training programs and workshops for your team — covering Indian MDR 2017, CDSCO submission processes, ISO 13485 QMS implementation, risk management (ISO 14971), and FSSAI compliance. Conducted at your facility across India or online for distributed teams.
Our Real Clients Result
An ISO 9001 for Quality Management, ISO 27001 for Information Security Management, and ISO 45001 for Occupational Health & Safety Management certified company.
Free Regulatory Audit
We assess your product, identify the exact CDSCO license type, and give you a complete roadmap — at no cost.
Regulatory Strategy
A custom plan for your product, timeline, and budget. No generic templates — every client is unique.
Dossier & Documentation
Full technical file, quality documentation, gap analysis — 100% aligned with latest CDSCO guidelines.
Submit & Follow Up
We file on CDSCO online (SUGAM) and proactively resolve every query within 48 hours.
Approval & Beyond
CDSCO certificate delivered. We continue supporting post-market compliance, renewals, and expansion.
What Our Clients Says
Real feedback from our happy clients about our quality and service.
Everything You Want to Know About CDSCO Registration
CDSCO full form is Central Drugs Standard Control Organisation. It is India's national regulatory authority under the Ministry of Health & Family Welfare, regulating drugs, medical devices, cosmetics, diagnostics, and clinical trials — ensuring all products meet mandatory safety and quality standards before reaching Indian patients.
Any manufacturer, importer, or distributor of medical devices, drugs, diagnostics, or cosmetics in India must legally obtain a CDSCO license or CDSCO registration certificate before selling. This applies to both Indian businesses and foreign manufacturers entering via an Authorised Indian Agent (AIA). Operating without approval is a criminal violation under the Drugs & Cosmetics Act 1940.
Timelines vary by product class. Class A medical devices: 3–6 months. Class B: 6–12 months. Class C & D: 12–18+ months. Cosmetics: 60–90 days. With TraccGlobal as your CDSCO consultant, our proactive 48-hour query management regularly cuts these timelines by 2–4 months compared to self-managed applications.
A CDSCO import license is required by importers bringing regulated products into India from overseas — it authorises legal importation and distribution. A CDSCO registration certificate is issued to manufacturers confirming product compliance with Indian standards. Both are mandatory before market entry. TraccGlobal handles both types seamlessly.
CDSCO online refers to the SUGAM e-Governance portal at cdscoonline.gov.in — India's official digital platform for all CDSCO license applications, registration submissions, and query responses. TraccGlobal manages the entire SUGAM portal process on your behalf — account setup, document uploads, form filing, and real-time query tracking. You never need to touch the portal yourself.
Yes. Foreign manufacturers can obtain CDSCO registration without a physical India office, but must appoint an Authorised Indian Agent (AIA) who is legally responsible for compliance in India. TraccGlobal can act as your AIA or help appoint one — making India market entry straightforward for companies from the USA, UK, Europe, Japan, and beyond.
Ready to Get Started?
TRACC Global Research and Consulting Pvt Ltd,
1271, Ground Floor, Sector-45, Gurugram,
Haryana-122001.
Mail Us
info@
traccglobal.com
Call Us
+918868886774
