Regulatory Representation · India
Indian Authorized Agent for Medical Devices, IVDs and Cosmetics
Overseas manufacturers cannot apply to CDSCO on their own. Shen Clinical Services acts as your Indian Authorized Agent (IAA): we hold your power of attorney, file the import licence application, answer CDSCO queries and carry the post-approval duties under the Medical Devices Rules, 2017, so your products reach the Indian market and stay compliant.
MDR 2017Rules 3(f), 34 to 39 govern authorised agents
MD-14 to MD-15Import licence application and licence
Power of AttorneyApostilled or embassy-authenticated
Post-Market DutiesChanges, recalls and retention
On this page
When You Need an Agent
Who Needs an Indian Authorized Agent?
Any overseas manufacturer that wants to sell regulated products in India needs an Indian applicant to hold its registration. The forms differ by product type:
| Product | Application | Licence / certificate | Authority |
|---|---|---|---|
| Medical devices (Class A to D) | Form MD-14 | Form MD-15 (import licence) | CDSCO |
| In vitro diagnostics (Class A to D) | Form MD-14 | Form MD-15 (import licence) | CDSCO |
| Devices for testing, evaluation or clinical investigation | Form MD-16 | Form MD-17 (import test licence) | CDSCO |
| Cosmetics | Form COS-1 | Form COS-2 (import registration certificate) | CDSCO |
| Drugs | Form 40 | Form 41 (registration certificate) | CDSCO |
Under Rule 3(f) of the Medical Devices Rules, 2017, an authorised agent is the Indian entity appointed by the overseas manufacturer through a power of attorney.
Eligibility
Eligibility Requirements for an Authorized Agent
A Qualifying Licence
Rule 34 requires the agent to hold a manufacturing licence, a wholesale licence, or a registration certificate in Form MD-42 for sale and distribution.
Power of Attorney
A power of attorney from the overseas manufacturer, apostilled in Hague Convention countries or authenticated by the Indian embassy elsewhere.
Indian Business Presence
A registered Indian entity with an Importer Exporter Code and an account on CDSCO’s online licensing portal.
Regulatory Capability
People who can prepare device and plant master files, answer technical queries and manage post-approval obligations for years, not just the first filing.
Government Fees
Import Licence Fees for Medical Devices in India
CDSCO fees for an MD-15 import licence under the Second Schedule of the Medical Devices Rules, 2017, paid in US dollars:
| Device class | Per overseas site | Per distinct device |
|---|---|---|
| Class A (medical device) | USD 1,000 | USD 50 |
| Class B (medical device) | USD 2,000 | USD 1,000 |
| Class C and D (medical device) | USD 3,000 | USD 1,500 |
| Class A and B (IVD) | USD 1,000 | USD 10 |
| Class C and D (IVD) | USD 3,000 | USD 500 |
Grouping devices correctly can lower the number of “distinct devices” you pay for. We check grouping before filing.
Responsibilities
Agent Responsibilities After Approval
The licence holder’s work starts after the MD-15 is granted. These are the main duties and deadlines under the Medical Devices Rules, 2017:
| Obligation | Rule / timeline |
|---|---|
| CDSCO decision on an MD-14 application | Up to 9 months from application (Rule 36) |
| Licence validity | Valid in perpetuity while the retention fee is paid every 5 years (Rule 37) |
| Late retention fee | 2% per month for up to 90 days; after that the licence is deemed cancelled (Rule 37) |
| Overseas regulatory action such as a recall or market withdrawal | Inform CDSCO within 15 days and stop sale in India (Rule 38) |
| Major change to device, site or labelling | Prior CDSCO approval, decided within 60 days (Rule 38) |
| Minor change | Notify CDSCO within 30 days (Rule 38) |
| Change in constitution of the manufacturer or agent | Notify within 30 days; fresh application within 180 days (Rules 38 and 39) |
| Labelling of imported devices | Import licence number and importer name and address on the label (Rule 44) |
| Residual shelf life at import | At least 60% for devices with a shelf life over one year (Rule 47) |
| Recall | Withdraw stock from the market, including hospitals, when CDSCO directs (Rule 38) |
Documents
Documents for an MD-14 Import Licence Application
A complete dossier is the quickest way to an import licence for medical devices in India. Your agent files:
- Covering letter and Form MD-14
- Power of attorney from the overseas manufacturer
- Agent’s wholesale or manufacturing licence, or Form MD-42
- Free sale certificate from the country of origin
- ISO 13485 certificate for the manufacturing site
- Plant Master File and Device Master File
- Labels and instructions for use
- Test reports and, where needed, clinical evidence
- Undertaking of compliance with the rules
Our Process
How We Act as Your Agent in India
STEP 01
Classification and Strategy
We confirm each device’s risk class, group products to control fees, and map which licences you need for devices, IVDs or cosmetics.
STEP 02
Power of Attorney and Dossier
We draft the power of attorney, guide apostille or embassy authentication, and build the Device and Plant Master Files.
STEP 03
MD-14 Filing and Queries
We file on CDSCO’s online portal, pay fees, and answer CDSCO queries quickly and in full.
STEP 04
MD-15 and Ongoing Duties
Once licensed, we manage changes, endorsements, retention fees, recalls and vigilance reporting for the life of the licence.
What We Cover
Our Authorized Agent Services
Agent appointment and licence holding
Import licence (MD-14 / MD-15)
IVD import licence
Cosmetic registration (COS-1 / COS-2)
Device classification and grouping
Device and Plant Master Files
Power of attorney drafting
Import test licence (MD-16 / MD-17)
Endorsement of new devices and sites
Post-approval changes
Retention fee and licence upkeep
Recall and vigilance support
FAQs
Indian Authorized Agent: Frequently Asked Questions
What is an Indian Authorized Agent?
An Indian Authorized Agent (IAA) is an Indian entity that an overseas manufacturer appoints through a power of attorney to deal with CDSCO on its behalf. The rules spell it “Indian authorised agent”. Under Rule 3(f) of the Medical Devices Rules, 2017, the authorised agent applies for and holds the import licence, and carries the post-approval duties for the products it imports.
Does a foreign manufacturer need an Indian Authorized Agent to sell medical devices in India?
Yes. Under Rule 34 of the Medical Devices Rules, 2017, the import licence application in Form MD-14 must be made by an authorised agent in India that holds a manufacturing licence, a wholesale licence or a registration certificate in Form MD-42. An overseas manufacturer cannot apply directly without one.
Can my distributor act as my Indian Authorized Agent?
A licensed distributor can be appointed, but the MD-15 import licence is then issued in the distributor’s name. If you later change distributor, the new agent must obtain its own licence. Many manufacturers appoint an independent agent so they can work with several distributors and keep control of their registrations.
How much does an import licence for medical devices in India cost?
Government fees for an MD-15 import licence are charged per overseas manufacturing site and per distinct device: USD 1,000 and USD 50 for Class A, USD 2,000 and USD 1,000 for Class B, and USD 3,000 and USD 1,500 for Class C and D. IVDs are charged USD 10 (Class A and B) or USD 500 (Class C and D) per device.
How long does it take to get an MD-15 import licence?
Rule 36 of the Medical Devices Rules allows CDSCO up to nine months from the date of application to grant or reject an import licence. The actual time depends on device class, dossier quality and how quickly queries are answered.
How do I change my Indian Authorized Agent?
An import licence is held by the agent named on it and cannot simply be handed over. The new agent files a fresh MD-14 with a new power of attorney and obtains its own MD-15. We plan the switch so the existing licence stays active until the new one is granted, avoiding a gap in supply.
Resource Spotlight
Know your product route? See our medical device registration, IVD registration in India and cosmetic registration in India services, or read our guide to IVD classification in India.
Enter the Indian Market With a Trusted Agent
New to India? Get a quote for agent appointment and your first import licence.
Changing agent? We plan the switch so your supply to India is not interrupted.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: Medical Devices Rules, 2017 (CDSCO); CDSCO medical device fee schedule; Cosmetics Rules, 2020; Drugs Rules, 1945. General regulatory information, not legal advice.