Indian Authorized Representative & CDSCO Authorized Agent
Enter one of the world's fastest growing medical device markets without a subsidiary in India. NexorTest acts as your independent, conflict-free Indian Authorized Representative for your MD 15 import licence, CDSCO liaison, and post market support under the Medical Device Rules 2017, and your market access stays in your control, not your distributor
Four Risk Based Device Classes Under India's MDR 2017
CDSCO classifies all medical devices and IVDs by risk based on intended use, invasiveness, and duration of contact. Your class determines the licensing authority, documentation, fees, and review timeline.
The lowest risk category devices such as surgical dressings, tongue depressors, and reusable surgical instruments. Lightest documentation burden and quickest review path.
- Fastest Review
- Basic Dossier
- Form MD-14/15
Low to moderate risk devices such as hypodermic needles, suction equipment, and thermometers. Moderate documentation with performance and safety evidence.
- Import Licence
- DMF & PMF
- ISO 13485
Moderate to high risk devices including bone fixation plates, ventilators, and infusion pumps. Requires a full technical dossier and robust risk-management evidence.
- Full Dossier
- ISO 14971
- Clinical Evidence
Highest risk devices such as heart valves, implantable defibrillators, and drug-eluting stents. Most rigorous technical and clinical scrutiny under MDR 2017.
- Highest Scrutiny
- Clinical Data
- Longest Timeline
Note: The registration process for a Class A (Non-Sterile & Non-Measuring) medical device in India takes place entirely online. Because this category is exempt from standard licensing regimes, it bypasses long wait times, field inspections. However, if your product is NSNM category one has to check in the approved database for eligibility check here
Your Import Licence Lives With Whoever You Appoint
Under the Medical Device Rules 2017, the MD-15 import licence is granted in the name of your Authorized Agent. Choosing the wrong agent can put your entire market access at risk.
Independent Agent
NexorTest as Your Neutral Representative We hold your MD-15 import licence in a neutral capacity with no commercial interest in selling your device. You can appoint, add, or change distributors freely, and your registration is never held hostage by a single commercial partner. If you ever leave, we hand over a complete, audit-ready file.
Distributor as Agent
Many manufacturers default to letting their distributor act as their Authorized Agent. The licence then sits in the distributor's name so when the relationship sours or you want a second distributor, you may be forced to re-register from scratch and lose months of market presence.
No Agent
CDSCO does not accept import-licence applications directly from foreign manufacturers without a legal entity in India. Appointing a licensed Indian Authorized Representative is a legal prerequisite for both notified and non-notified devices across every risk class.
End-to-End Indian Authorized Representation
From appointment and licence-holding through post-market vigilance, NexorTest manages every aspect of your CDSCO regulatory journey under one expert roof.
Authorized Agent Appointment & PoA
We become your formally appointed Indian Authorized Representative, holding the wholesale licence (Form 20B/21B) or MD- 42 certificate, an active CIN, a verified SUGAM account, and your Power of Attorney everything CDSCO requires before any application can be filed.
CDSCO Registration & MD-15 Licence
We classify your device, compile the Device Master File and Plant Master File, submit Form MD-14 through SUGAM, manage fees and queries, and hold the resulting MD-15 import licence in our name on your behalf for Class A, B, C and D devices.
Regulatory Liaison with CDSCO
We are your single point of contact with the regulator managing correspondence, technical clarifications, and deficiency responses, and relaying application status, timelines, and reportable changes back to your team in clear, actionable terms.
Post-Market Surveillance & Vigilance
Your obligations don't end at approval. We manage Materiovigilance and adverse event reporting to CDSCO, Periodic Safety Update Reports, recalls and field safety corrective actions, master file maintenance, and licence renewals.
IVD & SaMD Registration
In Vitro Diagnostic registration under the same Class A-D framework, including performance evaluation evidence and labelling. For Software as a Medical Device, we manage software lifecycle, validation, and cybersecurity documentation aligned with CDSCO's digital health expectations.
Labelling & Importer Compliance
We authorise our agent details on your device labelling per MDR 2017, ensure label and IFU compliance, and coordinate importer logistics so your product clears customs and reaches shelves without compliance gaps or the most common causes of rejection.
India's Independent CDSCO Specialist
We combine an on the ground Indian regulatory team with global reliance expertise to deliver faster, more predictable CDSCO approvals with no conflict of interest.
Independent Agent You Keep Control
We hold your MD-15 import licence as a neutral representative, so you can switch or add distributors anytime without your registration being held hostage by a single commercial partner.
On the Ground Indian Regulatory Team
Professionals who work with CDSCO reviewers, SUGAM submission codes, and the Medical Device Rules 2017 first hand not an offshore desk learning the system from a distance.
Clean Transfer Guarantee
If you ever switch representatives, we hand over a complete, audit-ready file no hostage documents, no re-registration surprises. The way a transfer should work.
One Partner for Global Market Access
Coordinate India CDSCO alongside US FDA, EU MDR/CE, UKCA, and 50+ other markets from a single integrated program reusing one technical dossier instead of rebuilding it for each.
Engineering Grade Dossier Rigour
Our testing and design teams identify technical file weaknesses before submission, helping reduce deficiency cycles during CDSCO review.
Six Steps to Your MD-15 Import Licence
A proven, transparent approach with one project lead throughout minimising deficiency queries and accelerating your path to the Indian medical device market.
Classification & Pathway Strategy
We confirm your CDSCO risk class (A, B, C or D) under MDR 2017, determine the correct import-licence pathway, and build a predicate strategy that leverages any existing FDA, CE, or other recognised approvals.
Appoint Authorized Representative
You grant Power of Attorney; NexorTest activates as your independent Indian Authorized Agent, with our wholesale licence/MD-42, active CIN, and verified SUGAM account ready to file.
Dossier Preparation
We compile the Device Master File, Plant Master File, ISO 13485 certificate, Free Sale Certificate, risk management file (ISO 14971), and MDR 2017-compliant labelling for the Form MD-14 application.
Pre-Submission Quality Check
We run a deficiency prevention review of the complete dossier to anticipate CDSCO queries before they are raised the single biggest driver of a faster, cleaner approval.
SUGAM Submission & Query Management
We submit Form MD-14 through the CDSCO SUGAM portal, pay government fees, and manage every technical query and deficiency response to keep the review clock moving toward approval.
MD-15 Licence & Post-Market
You receive your MD-15 import licence, held in our name on your behalf. We set up Materiovigilance reporting and manage variations and renewals throughout the licence lifecycle.
CDSCO Expertise Across Every Device Category
From implantables to digital health, our regulatory specialists cover the full breadth of medical technology entering the Indian market.
- 🫀 Cardiovascular & Implants
- 🧬 In Vitro Diagnostics
- 💻 SaMD & Digital Health
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics
- 🦷 Dental Devices
- 🏥 Electro-Medical Equipment
- 📱 Wearables & Remote Monitoring
- 🔬 Laboratory Equipment
- 🧠 Neurological Devices
- ❤ Wound Care
- 🛡 Sterilization Equipment
- 💡 AI/ML Medical Devices
CDSCO Indian Authorized Representative FAQs
What is an Indian Authorized Representative for medical devices?
An Indian Authorized Representative also called an Indian Authorized Agent or in-country representative is a locally licensed entity appointed by a foreign medical device or IVD manufacturer to act on its behalf before the Central Drugs Standard Control Organisation (CDSCO). Under the Medical Device Rules 2017, a foreign manufacturer without a legal entity in India cannot apply for an import licence directly. The Authorized Agent holds Power of Attorney, submits applications through the CDSCO SUGAM portal, holds the MD-15 import licence, serves as the official point of contact with the regulator, and carries legal responsibility for the device marketed in India.
Is an Indian Authorized Representative mandatory?
Yes. Any foreign manufacturer without a registered legal entity in India must appoint an Indian Authorized Representative to register and import medical devices or IVDs. CDSCO does not accept import licence applications directly from overseas manufacturers. A licensed authorized agent is required for both notified and non-notified devices across all four risk classes Class A, B, C and D and the MD-15 import licence is issued in the agent’s name.
What licences must an Indian Authorized Agent hold?
An Indian Authorized Agent must hold either a valid wholesale drug licence in Form 20B and 21B (renewed via Form 21C) under the Drugs and Cosmetics Rules, or a medical device sale/distribution Registration Certificate in Form MD-42 under the Medical Device Rules 2017. The agent must also be a registered Indian company with an active Corporate Identification Number (CIN), hold a valid Power of Attorney from the manufacturer, and operate a verified account on the CDSCO SUGAM portal to file the Form MD-14 import-licence application.
How are medical devices classified under CDSCO?
Under the Medical Device Rules 2017, CDSCO uses a four-tier, risk-based classification harmonised with the GHTF/IMDRF framework. Class A covers low-risk devices such as surgical dressings; Class B covers low-to-moderate risk devices such as hypodermic needles; Class C covers moderate-to-high risk devices such as bone fixation plates and ventilators; and Class D covers high-risk devices such as heart valves and implantable defibrillators. Classification is determined by intended use, invasiveness, duration of contact, and whether the device is active and it sets the licensing authority, documentation, fees, and timeline.
Import licence vs registration certificate what's the difference?
For imported medical devices, the foreign manufacturer applies through its Indian Authorized Agent for an import licence in Form MD-15, granted by the Central Licensing Authority after submitting Form MD-14 via SUGAM. The MD-15 licence permits import and sale of the device in India and is held in the agent’s name. This differs from the MD-42 Registration Certificate, which authorises an Indian entity to sell, stock, or distribute devices, and from manufacturing licences (MD-5/MD-9) used by domestic manufacturers. NexorTest manages the full Form MD-14 to MD-15 pathway as your Authorized Agent.
How long does CDSCO registration take in India?
Timelines depend on device class. For imported devices, a Class A or B import licence (Form MD-15) typically takes around 6 to 9 months, while Class C and D devices generally take 9 months or longer, depending on dossier completeness and CDSCO query cycles. Devices approved by recognised regulators (US FDA, EU CE, Health Canada, Japan, Australia TGA) may benefit from a predicate-based, abridged assessment that shortens review. Documentation quality is the single biggest driver of timeline; NexorTest’s pre-submission review minimises deficiency queries that pause the review clock.
What documents are required for a CDSCO import licence?
A CDSCO import-licence application (Form MD-14) typically requires: Power of Attorney appointing the Indian Authorized Agent; the agent’s wholesale licence (Form 20B/21B) or MD-42 certificate; a Device Master File and Plant Master File; ISO 13485 certificate; a Free Sale Certificate or marketing authorisation from the country of origin; the manufacturer’s quality and regulatory approvals (e.g., US FDA, CE); risk management evidence (ISO 14971); and labelling compliant with the Medical Device Rules 2017. NexorTest compiles and quality-checks the complete dossier before submission via SUGAM.
Why choose an independent representative over your distributor?
Because the MD-15 import licence is granted in the name of your Authorized Agent, appointing your distributor as your agent ties your market access to that commercial relationship. If you later change distributors, the licence sits in the former distributor’s name and you may be forced to re-register from scratch, losing months of market presence. An independent Authorized Representative such as NexorTest holds the licence neutrally, so you can appoint, add, or replace distributors freely, avoid conflicts of interest, and protect your registration if a commercial relationship ends.
Ready to Enter the Indian Medical Device Market?
Speak with our CDSCO regulatory specialists for a free assessment. We will review your device classification, explain the registration process, and outline the steps required for an MD-15 Import Licence.