Import License for Medical Devices (MD-15)
Import License for Medical Devices (MD-15)
The Indian market for medical tools is booming; global companies want to meet the rising need for better tech, diagnostics, healthcare. However, importing these devices requires meeting rules set by the 2017 Medical Device Regulations – licenses are a must.
Getting a go-ahead to bring medical equipment into India often hinges on one key permission – the Import License. The CDSCO handles these, letting firms offer approved devices nationwide. Here’s a straightforward look at obtaining an MD-15 license: what triggers the need for it, application details, necessary paperwork, associated expenses, alongside how expert assistance can help navigate each step.
Required Specific License
To import medical devices – those falling into Classes A, B, C, or D – you’ll need an Import License (Form MD-15), following the rules IMDR 2017 and D&C act 1945. Getting one involves first applying via Form MD-14,on SUGAM Portal alongside any necessary paperwork.
Important Terminologies
- MD14 – It is an application form to get a license to import medical devices of class A, B, C or D except Class A (Non Sterile – Non Measuring).
- MD15 – It is a license form that CDSCO grants to let people bring medical devices into India based on the classification A, B, C or D. MD 15 is a registration issued by the CDSCO for the importer to import medical devices into the country. It is mandatory for all devices that are related to the medical industry.
- Authorized Agent – Indian importer or person who acts on behalf of the company representing in India. Authorized agent must have wholesale license namely MD42 or 20B-21B.
- Legal Manufacturer – A Forgien representative or trader / Exporter who actually made contract with an Indian Authorized agent but not actually manufactures the medical device.
- Actual Manufacturer – The Forgien manufacturer who actually manufactures the medical device
# Single company or person can become both a Legal manufacturer and an Actual manufacturer if they perform both the activities.
Process for Import Licence For Medical Device
1. Determine Device Classification
Figure out if your item falls into risk category A – pretty safe – B, C, or D – most dangerous. That choice dictates how closely we examine it alongside what paperwork is needed.
Class | Risk Level | Examples |
A | Low | Bandages, Thermometers |
B | Low-Medium | Dental tools, X-ray machines |
C | Medium-High | Infusion pumps, Anesthesia machines |
D | High | Pacemakers, Heart valves |
2. Appoint Indian Authorized Agent
Overseas companies need a local Indian partner to handle communication with the country’s drug regulators.
3. Submit Application via SUGAM Portal
To get permission to import, someone – either the importer themselves or their representative – accesses the CDSCO SUGAM website then completes Form MD-14.
4. Upload Required Documents
Get those site specifics, gadget info, ISO approvals, free sale docs, also testing results onto the platform – make sure they’re in the correct file type.
5. Payment of Government Fees
Cover any required state charges through the official website following current guidelines.
6. Scrutiny and Query Resolution
Inspectors might ask detailed questions, so reply quickly to keep things moving.
7. Inspection (if required)
Sometimes, specifically with devices categorized as C or D, the CDSCO might check things out in person – or review paperwork – prior to giving its okay.
8. Issuance of Import License (Form MD-15)
Once testing goes well, the CDSCO issues a Form MD-15 license, allowing particular medical devices to be brought into – then sold within – India.
List Of Documents Required For MD Import Registration
-
Notarized Free Sale Certificate Issued by the competent authority from the country of origin or approved countries (e.g., USA, EU, etc.).
-
Latest Inspection / Audit Report Inspection or audit report of the manufacturing site conducted within the last three (3) years.
-
Notarized ISO 13485 Certificate Valid ISO 13485 Quality Management System certificate of the manufacturing site.
-
Notarized CE Certificates Includes the following:
1. Quality Assurance Certificate
2. Design Certificate
3. Declaration of Conformity -
Plant Master File (Appendix I) Comprehensive details of the manufacturing facility, infrastructure, and quality systems.
-
Device Master File (Appendix II) Detailed information about the medical device, including design, materials, intended use, and risk analysis.
-
Product Label Must clearly mention:
1. Importer’s name and address
2. Lot / Batch Number
3. Quantity
4. Date of Manufacture and Expiry -
Notarized Manufacturing Site Registration Certificate Proof of registration of the overseas manufacturing site with the regulatory authority.
-
Selling & Distribution License License issued by the concerned local authority permitting sale and distribution in India.
-
Proof of Government Fee Payment Copy of the payment receipt or challan for Importer Registration under CDSCO.
-
FDA Import License Copy of valid FDA Import License (validity: five years).
-
Power of Attorney (Notarized and Apostilled) Issued by the manufacturer, authorizing the Indian agent/importer to act on their behalf in India.
-
Covering Letter Addressed to the Licensing Authority, stating the purpose of submission and the list of enclosed documents.
-
Authorization Letter from Manufacturer Formal letter from the manufacturer confirming appointment of the Indian importer/authorized representative.
-
For Renewal Applications 1. Copy of the previous Import License
2. Renewal fee payment proof (challan/receipt)
Validity & Renewal
Your MD-15 import license doesn’t expire – however, to keep it active, you need to pay a renewal fee once every five years, following the guidelines from the 2017 Medical Device Rules. Fail to pay on time, consequently the license becomes invalid; you’ll then have to apply again.
Government Fees Involved
Government Fee (Non IVD Products) :-
|
S.No.
|
Applicant
|
Class of Device
|
Govt fees for plant (Non IVD)
|
(Non IVD) per product
|
|---|---|---|---|---|
|
1.
|
Importer
|
A
|
$1,000
|
$50
|
|
2.
|
Importer
|
B
|
$2000
|
$1000
|
|
Importer
|
C
|
$3000
|
$1500
|
|
|
4
|
Importer
|
D
|
$3000
|
$1500
|
Government Fee (IVD Products)
|
S.No.
|
Applicant
|
Class of Device
|
Govt fees for plant (Non IVD)
|
(Non IVD) per product
|
|---|---|---|---|---|
|
1.
|
Importer
|
A
|
$1,000
|
$10
|
|
2.
|
Importer
|
B
|
$2000
|
$10
|
|
3
|
Importer
|
C
|
$3000
|
$500
|
|
4
|
Importer
|
D
|
$3000
|
Calculation of Govt Fee - (Plant Fee x No. of Manufacturing site) + (Product Fee x No of Products)
MD15 Retention:
It refers to the process of keeping a medical device license or registration valid by regularly renewing it. This ensures that the manufacturer or importer complies with regulations and can legally continue their activities.
– We have to pay total fees same as for fresh MD15 License
MD15 Endorsement:
It refers to an official modification or addition to an existing license or registration certificate for a medical device. It typically happens when there are changes in details, such as adding a new product to the existing license or updating specific information.
– We have to pay only device fees not plant fees.
MD15 Post Approval Changes:
For Any changes in form MD 15 are done as post approval changes.(address change in India,change in details of approved device /model).
We need to apply this on SUGAM portal.
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Client Testimonials
▪ Yes. Each distinct device/model requires a separate application, documentation, and fee.
A change in agent requires a fresh MD15 license application; the existing license cannot be transferred.
▪ For certain device classes (especially C & D), CDSCO may require an overseas site inspection, incurring additional fees and extending timelines.
Importers must maintain records, report adverse events, update regulatory documents, and pay retention fees every 5 years to keep the license valid.
Imports must be routed through notified ports, but stocking can occur at any registered warehouse in India.