MEDICAL DEVICES Regulatory Services
Getting your medical device approved in India is complex — wrong classification, one missing document, or a slow query response can delay your product by 6–12 months. TraccGlobal delivers expert medical devices regulatory services that remove every obstacle between you and market entry. 98% first-attempt CDSCO approval rate. 48-hour query resolution.
200+ Global Brands Served
98% First-Attempt Approval
48+ Query Resolution
10 yr+ Years Experience
Quick Answer
Medical devices regulatory services in India involve obtaining CDSCO approval under the Medical Devices Rules 2017 (MDR 2017) before any medical device can be legally sold, imported, or manufactured in India. Devices are classified into four risk-based categories — Class A (low risk) to Class D (high risk) — each requiring a specific license from either the Central Drugs Standard Control Organisation (CDSCO) or State Licensing Authorities (SLA). Foreign manufacturers, including US companies, must appoint an Authorized Indian Agent (AIA) and submit applications through the SUGAM online portal. Key approvals include the Import License (Form MD-14/MD-15), Manufacturing License (Form MD-3 through MD-10), and the 2022-mandatory MD-42 Retailer Registration Certificate. TraccGlobal provides end-to-end MDR 2017 compliance support — from device classification and dossier preparation to SUGAM filing and post-market surveillance — with a 98% first-attempt approval rate and 48-hour query turnaround.
What Are Medical Devices Regulatory Services?
If you make or import a medical device — whether it is a simple bandage or a cardiac stent — you cannot legally sell it in India without approval from the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules 2017. This is not optional. Selling without a license is a criminal violation under the Drugs & Cosmetics Act 1940.
Medical devices regulatory services are professional consulting services that guide manufacturers, importers, and distributors through this entire approval process — from figuring out your device’s risk class to getting your CDSCO registration certificate in hand, without delays or rejections.
India’s medical device market is projected to reach $50 billion by 2030. For US companies looking to enter this market, navigating MDR 2017 compliance correctly from day one is the difference between a smooth launch and a costly 12-month delay.
TraccGlobal is a Gurugram-based regulatory consultancy with over a decade of specialized experience in medical devices regulatory services. We have helped 200+ global brands — from startups to Fortune 500 companies — successfully enter the Indian market.
- US, EU & global manufacturers exporting to India
- Indian manufacturers seeking CDSCO production licenses
- Importers bringing Class A–D devices into India
- Distributors & wholesalers needing MD-42 registration
- Startups developing new / novel medical devices
- IVD (In Vitro Diagnostic) kit manufacturers
- Software as Medical Device (SaMD) companies
- Companies facing CDSCO query responses or rejections
- Firms requiring ISO 13485 QMS for CDSCO alignment
- Clinical research teams needing investigational device permits
Understanding the Basics
What Are Medical Devices Regulatory Services?
Under India’s Medical Devices Rules 2017, all devices are classified into four risk-based categories. Understanding your correct class is the first and most critical step in the medical devices regulatory services process — misclassification causes delays, wrong fees, and rejection.
2026 Update: CDSCO reclassified 553 medical devices across cardiovascular and neurological segments in 2025. AI-driven diagnostics and Software as a Medical Device (SaMD) now have a clearer, structured risk-based classification pathway. If your device was registered before 2024, verify your classification still applies under the latest MDR 2017 amendments.
Our Medical Devices Regulatory Services
TraccGlobal offers a complete range of medical devices regulatory services under one roof — from your first device classification question to your post-market compliance obligations. Everything your product needs to succeed in India.
CDSCO Import License (MD-14 / MD-15)
The most critical approval for any foreign manufacturer bringing devices into India. We prepare the full technical dossier, manage SUGAM portal submissions, and respond to CDSCO queries within 48 hours. All device classes (A–D), including IVD and non-IVD. Our zero-error documentation policy means no rework, no second chances needed.
Diagnostics · IVD · Blood Tests · PCR Kits
CDSCO Manufacturing License (MD-3 to MD-10)
Indian manufacturers need a production license before making any regulated device. We handle applications for Class A & B (SLA) and Class C & D (CDSCO), including Loan License applications. We also assist with SUGAM portal account setup, plant inspection preparation, and QMS alignment for smooth approvals.
Novel Devices · First-in-India · No Predicate
Authorized Indian Agent (AIA) Service
Foreign manufacturers — including US companies — cannot submit CDSCO applications directly. An Authorized Indian Agent holding a valid Form 20B/21B wholesale license is legally required. TraccGlobal can act as your AIA or help you appoint one, managing all regulatory communications and legal responsibilities on your behalf.
Clinical Trials · Investigational Devices · MDR 2017
IVD (In Vitro Diagnostic) Registration
IVD kits — from blood glucose tests to PCR diagnostic kits — follow a separate but equally strict regulatory pathway. We handle IVD import licenses, test licenses for evaluation (MD-16/MD-17), clinical performance evaluation applications (MD-24/MD-25), and new IVD device permissions (MD-28/MD-29).
Diagnostics · IVD · Blood Tests · PCR Kits
New Medical Device Approval (Without Predicate)
If your device has no approved predicate in India, you need special permission under MD-26/MD-27 before launch. This involves clinical investigation planning, safety and efficacy data submission, and Subject Expert Committee (SEC) meetings. TraccGlobal has guided multiple novel device approvals through this complex pathway.
Novel Devices · First-in-India · No Predicate
Clinical Investigation & Investigational Device
For devices still under development or those being evaluated for new indications, CDSCO permission under MD-22/MD-23 is required before any clinical investigation begins. We guide you through the entire process — protocol design review, ethics committee coordination, application filing, and post-study compliance reporting.
Clinical Trials · Investigational Devices · MDR 2017
MD-42 Retailer & Wholesaler Registration
Since September 2022, all retailers, wholesalers, and stockists of medical devices must obtain a Registration Certificate in Form MD-42 from the State Licensing Authority. Operating without MD-42 is a compliance violation. TraccGlobal handles the full application on Form MD-41, submission, and certificate follow-up.
Mandatory from Sept 2022 · Retailers · Stockists
SaMD — Software as a Medical Device
CDSCO issued Draft Guidance on Medical Device Software in October 2025, bringing AI diagnostics, health monitoring apps, and ML imaging tools under clear MDR 2017 classification. We help SaMD developers classify their software correctly, build the required QMS, and prepare technical documentation for CDSCO approval.
SaMD · AI Diagnostics · Digital Health · 2025 Update
Global Regulatory Certifications
Expand beyond India. TraccGlobal delivers CE Marking (EU MDR 2017), FDA 510(k) consulting, UK CA certification, SFDA (Saudi Arabia), WHO Prequalification, and device registration across 20+ countries. One team, one relationship — global reach from the same expert consultancy that handles your Indian medical devices regulatory services.
CE · FDA 510(k) · UK CA · SFDA · WHO-PQ
Free Regulatory Audit
We assess your device, determine classification (Class A–D), and map the exact CDSCO license pathway.
Regulatory Strategy
A custom plan for your product, budget, and timeline with realistic CDSCO approval estimates.
Dossier Preparation
Complete technical documentation including DMF, PMF, QMS records, FSC, and all supporting files.
SUGAM Filing & Query Management
We file on CDSCO SUGAM portal and respond to queries within 48 hours.
Approval & Post-Market
Certificate delivery with ongoing support for renewals, updates, and compliance.
CDSCO Government Fee Structure
Below are the official CDSCO government fees for medical device import and manufacturing licenses under MDR 2017. These are statutory fees payable to the government — separate from TraccGlobal’s professional consulting fees.
| LICENSE TYPE | DEVICE CLASS | APPLICATION FORM | GRANT FORM | PLANT FEE | PER PRODUCT FEE | AUTHORITY |
|---|---|---|---|---|---|---|
| Import License | Class A (Non-IVD) | MD-14 | MD-15 | $1,000 | $50 | CDSCO |
| Import License | Class B (Non-IVD) | MD-14 | MD-15 | $2,000 | $1,000 | CDSCO |
| Import License | Class C Class D (Non-IVD) | MD-14 | MD-15 | $3,000 | $1,500 | CDSCO |
| Import License | Class A Class B (IVD) | MD-14 | MD-15 | $1,000 | $10 | CDSCO |
| Import License | Class C Class D (IVD) | MD-14 | MD-15 | $3,000 | $500 | CDSCO |
| Manufacturing License | Class A Class B | MD-3 | MD-5 | ₹5,000 | ₹500 | SLA (State) |
| Manufacturing License | Class C Class D | MD-7 | MD-9 | ₹50,000 | ₹1,000 | CDSCO |
| Test License (Import) | All Classes A–D | MD-16 | MD-17 | $100 | — | CDSCO |
| Clinical Investigation | All Classes | MD-22 | MD-23 | ₹1,00,000 | — | CDSCO |
| MD-42 Registration (Retail/Wholesale) | All Classes | MD-41 | MD-42 | Varies by State | — | SLA (State) |
India Medical Device Regulatory Updates 2025–2026
The Indian medical device regulatory landscape has changed significantly. Here is what every manufacturer and importer needs to know right now to maintain MDR 2017 compliance.
Key Regulatory Changes (2025-2026)
SaMD Draft Guidance — October 2025
CDSCO released a structured Draft Guidance on Medical Device Software (MDS). AI diagnostics, disease monitoring apps, and clinical decision support tools now have a clear risk-based classification pathway under MDR 2017. SaMD companies must review classification immediately.
553 Devices Reclassified — Early 2025
CDSCO undertook a risk-based reclassification of 553 medical devices in cardiovascular and neurological segments. If your device falls in these categories, verify your current classification and license type — you may need to reapply under a different class.
Parliamentary Panel: Decentralisation Proposal
India's Parliamentary Panel on Health recommended decentralising CDSCO approvals to state drug authorities for all device classes, including imports. If implemented, this could significantly accelerate Class C & D approval timelines — and change where applications are filed.
MD-42 — Mandatory Since September 2022
All retailers, wholesalers, and stockists of medical devices — including IVD products — must hold a valid MD-42 Registration Certificate from the State Licensing Authority. Non-compliance carries serious legal consequences. If you sell devices and don't have MD-42, act now.
SUGAM Portal — Full Digital-First Mandate
All CDSCO applications, responses, and license submissions must go through the SUGAM e-portal. No offline paper submissions are accepted for new applications. SUGAM also now supports real-time query tracking and approval status updates for all medical devices regulatory services submissions.
Approval Backlog — 250+ Pending Beyond 90 Days
As of 2025–2026, over 250 import applications remained pending beyond 90 days at CDSCO — even for devices already approved by FDA, CE, or TGA. Proactive 48-hour query management, like TraccGlobal provides, is now essential to avoid your application becoming a statistic.
Case Study: US Orthopedic Implant Company Enters Indian Market
Class C Orthopedic Implant — CDSCO Import License in 11 Months
The Challenge
A mid-sized US orthopedic implant manufacturer with CE and FDA clearance had tried twice on their own to obtain CDSCO medical device registration for their Class C knee implant system in India — and failed both times due to incomplete plant master files and incorrect Power of Attorney documentation. After 18 months of failed attempts and significant internal legal costs, they engaged TraccGlobal for medical devices regulatory services.
What TraccGlobal Did
Our team conducted a full regulatory gap audit in the first week, rebuilt their Device Master File and Plant Master File from scratch to match CDSCO's exact format, arranged a compliant Power of Attorney notarized and apostilled from the US, set up AIA representation, and submitted a zero-error dossier through the SUGAM portal. When CDSCO raised 3 queries during review, we responded to all within 48 hours. The CDSCO import license (MD-15) was granted in 11 months — 6 months faster than the typical Class C timeline in India.
We had tried twice on our own to get our CDSCO import license and failed both times. TraccGlobal stepped in, fixed our documentation in weeks, and got our approval 3 months faster than expected. Their query resolution speed is genuinely unmatched in India
Rajesh Sharma
Operations Manager, US Orthopedic Manufacturer
Why Global Companies Choose TraccGlobal for Medical Devices Regulatory Services
There are hundreds of regulatory consultants in India. Here is what makes TraccGlobal measurably different — in numbers, not words.
98%
First-Attempt CDSCO Approval Rate
Our zero-error dossier preparation approach means your application is right the first time. No rework. No re-filings. No extra government fees. The industry average first-attempt approval rate is under 60%.
48hr
Query Resolution — Guaranteed
CDSCO approvals stall most often because applicants are slow to respond to regulatory queries. We respond to every single CDSCO query within 48 hours — faster than any other medical devices regulatory services provider in India.
10+
Years of Deep MDR 2017 Expertise
We are not a generalist firm. Our entire practice is built around medical devices, IVD, and pharmaceutical regulatory affairs. We know CDSCO guidelines, SUGAM portal behaviors, and examiner expectations at a depth that only comes from years of daily practice.
200+
Global Brands Served Across 20+ Countries
US, European, Japanese, and Korean manufacturers trust TraccGlobal for India market entry. We understand the documentation formats that global regulatory bodies issue and know exactly how to translate them for CDSCO submissions.
1pt
One-Point Solution — No Handoffs
TraccGlobal handles everything from CDSCO registration to ISO 13485 QMS, CE Marking to FDA 510(k), and even factory setup and turnkey project consultancy — under one roof. You work with one team, one point of contact, from start to finish.
AI
Ready for SaMD, AI & Digital Health Regulation
As CDSCO's 2025 SaMD Draft Guidance brings AI diagnostic tools and health apps into regulatory scope, TraccGlobal is already helping digital health companies classify, document, and approve their software-driven medical devices under the latest MDR 2017 framework.
F.A.Q
Frequently Asked Questions About Medical Devices Regulatory Services
Real questions asked on Google — answered clearly so you can make informed decisions about your CDSCO compliance journey.
What are medical devices regulatory services in India?
Medical devices regulatory services in India are expert consulting services that help manufacturers, importers, and distributors get their products approved by CDSCO (Central Drugs Standard Control Organisation) under the Medical Devices Rules 2017 (MDR 2017). This covers the full process — device classification (Class A to D), dossier preparation, SUGAM portal submission, import license (MD-14/MD-15), manufacturing license, IVD registration, clinical investigation permissions, and post-market compliance. Without proper medical devices regulatory services, many companies face application rejections, 12–18 month delays, and costly rework.
How long does CDSCO medical device registration take in India?
CDSCO medical device registration timelines vary by risk class. Class A devices take approximately 3–6 months. Class B devices typically take 6–12 months. Class C and D devices require 12–18+ months due to more extensive technical review. IVD kits follow a similar timeline to their equivalent device class. With TraccGlobal’s proactive 48-hour query management and zero-error dossier preparation, our clients regularly achieve approvals 2–4 months faster than the industry average.
What is the difference between Class A, B, C, and D medical devices?
Under India’s MDR 2017, medical devices are classified into four risk categories: Class A (low risk) covers basic devices like bandages and walking aids that are self-regulated unless sterile. Class B (low-moderate risk) includes syringes, IV cannulas, and glucometers regulated by State Licensing Authorities (SLA). Class C (moderate-high risk) covers longer-term implantables like orthopedic implants and dialysis machines, regulated by CDSCO. Class D (high risk) includes life-sustaining devices like cardiac stents and pacemakers with the strictest regulatory scrutiny. For import licenses, all classes (A through D) require CDSCO approval — only manufacturing licenses for Class A and B go to SLA.
Can a US or foreign company register a medical device in India without an India office?
Yes. Foreign manufacturers — including US, European, and Asian companies — can fully obtain CDSCO medical device registration without having a physical office in India. However, they must appoint an Authorized Indian Agent (AIA) who holds a valid wholesale license in Form 20B and 21B. This AIA is legally responsible for all regulatory communications with CDSCO and must be physically based in India. TraccGlobal can serve as your Authorized Indian Agent (AIA) or help you identify and appoint a suitable entity — making India market entry completely straightforward for global companies.
What documents are required for CDSCO medical device import license (Form MD-14)?
Documents required for a CDSCO import license application (Form MD-14) include: completed MD-14 application form, Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate from the country of origin, ISO 13485 Quality Management System certificate, prior regulatory approvals (FDA, CE marking, TGA etc.), Power of Attorney notarized and apostilled in favor of the Indian agent, Undertaking of Truthfulness, government fee payment receipt, detailed product technical specifications and labeling, and undertaking by the manufacturing company. The exact requirements vary by device class and whether the device is IVD or non-IVD. TraccGlobal prepares all documentation to zero-error standards, aligned with CDSCO’s current guidelines.
What is the SUGAM portal and how does it work for medical device registration?
SUGAM (cdscoonline.gov.in) is CDSCO’s official e-governance platform for all medical device regulatory services submissions. All import licenses, manufacturing licenses, clinical investigation permissions, and query responses under MDR 2017 must be filed through SUGAM — no offline applications are accepted for new submissions. SUGAM allows real-time tracking of application status, query monitoring, and approval notifications. The portal requires registration of both the manufacturer and the Indian agent, along with digital document uploads in specified formats. TraccGlobal manages the entire SUGAM process on your behalf, from initial account setup through to approval certificate download.
What is the cost of CDSCO medical device registration in India?
CDSCO government fees for medical device import licenses are: Class A — $1,000 (plant registration) + $50 per product; Class B — $2,000 (plant) + $1,000 per product; Class C and D — $3,000 (plant) + $1,500 per product. For IVD devices, Class A/B IVD import license costs $1,000 (plant) + $10 per product; Class C/D IVD is $3,000 (plant) + $500 per product. Manufacturing license fees for Indian manufacturers are lower — Class A/B is ₹5,000 (plant) + ₹500 per product; Class C/D is ₹50,000 (plant) + ₹1,000 per product. These are statutory government fees. Professional consulting fees from TraccGlobal are quoted separately based on device complexity, class, and number of products.
What changed in India medical device regulations in 2025–2026?
Several important changes occurred in 2025–2026. First, CDSCO reclassified 553 medical devices in cardiovascular and neurological segments under a new risk-based review — manufacturers in these categories must verify their current classification remains valid. Second, CDSCO issued its Draft Guidance on Medical Device Software (SaMD) in October 2025, bringing AI diagnostic tools and health monitoring applications under MDR 2017 classification for the first time. Third, India’s Parliamentary Panel on Health and Family Welfare recommended decentralizing CDSCO approvals to state drug authorities — a proposal that could significantly change the approval landscape if implemented. Fourth, the mandatory MD-42 Retailer/Wholesaler Registration Certificate (in force since September 2022) continues to be strictly enforced. TraccGlobal keeps all clients updated on regulatory changes and proactively advises on any required compliance adjustments.
Ready to Get Your Medical Device Approved in India?
Stop losing time to incomplete applications and slow query responses. TraccGlobal’s medical devices regulatory services team delivers zero-error CDSCO approvals — faster, cleaner, and with zero rework. Start with a free regulatory audit today.