CDSCO Medical Device Import Licence (Form MD-14 / MD-15)
To import a medical device or IVD for sale in India, the authorised agent applies to CDSCO in Form MD-14 and the Central Licensing Authority grants the import licence in Form MD-15 under the Medical Devices Rules, 2017. Corpseed prepares and files it.
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What is the CDSCO medical device import licence (MD-14 / MD-15)?
To import a medical device or an in vitro diagnostic (IVD) medical device for sale or distribution in India, you need an import licence under Chapter V of the Medical Devices Rules, 2017 (MDR). The application is made in Form MD-14 to the Central Licensing Authority at CDSCO through the online portal, and the licence is granted in Form MD-15 (MDR rules 34 and 36).
The applicant is the authorised agent: a person, firm or organisation appointed by the overseas manufacturer through a power of attorney to import the device into India (rule 3(f)). The authorised agent must hold a licence to manufacture for sale or distribution, a wholesale licence for sale or distribution, or a registration certificate in Form MD-42 (rule 34(1)).
After examining the documents, and the inspection report if an inspection was carried out, the Central Licensing Authority grants the licence in Form MD-15 or rejects the application with written reasons, within nine months from the date of application (rule 36(1)). If rejected, you may appeal to the Central Government within 45 days (rule 36(2)).
When MD-15 is not the right route
- Class A non-sterile and non-measuring devices: exempt from the import licence; the importer registers the device on the Online System for Medical Devices instead (rules 19J and 19K, inserted by G.S.R. 777(E) dated 14 October 2022). See our NSNM registration page.
- Import for test, evaluation, clinical investigation, demonstration or training: a separate test licence, applied for in Form MD-16 and granted in Form MD-17.
- Adding devices or sites to an existing MD-15: an endorsement application in Form MD-14. See our MD-14 endorsement page.
Classes of medical devices (A, B, C, D)
Under MDR rule 4, medical devices and IVDs are each classified by risk, using the parameters in Part I (devices) and Part II (IVDs) of the First Schedule:
| Class | Risk |
|---|---|
| Class A | Low risk |
| Class B | Low moderate risk |
| Class C | Moderate high risk |
| Class D | High risk |
The Central Licensing Authority classifies devices based on their intended use and publishes class-wise lists on the CDSCO website (rule 4(3) and (4)). CDSCO continues to publish risk classification lists for device groups.
Clinical investigation
- If a free sale certificate has been issued by the regulator of Australia, Canada, Japan, a European Union country, the United Kingdom or the United States of America, the licence is granted without clinical investigation (rule 36(3)).
- For other countries, Class C and Class D devices may be licensed after safety and effectiveness are established through clinical investigation in India (rule 36(4)).
- For other countries, Class A (other than non-sterile and non-measuring) and Class B devices may be licensed on published safety and performance data or clinical investigation in the country of origin, with a free sale certificate from the country of origin (rule 36(5)).
- An investigational device or new IVD first needs permission in Form MD-27 or MD-29 (rule 36(6)).
Documents for Form MD-14
The documents come from the Fourth Schedule of the MDR and CDSCO's checklist for a fresh MD-14 application:
- Covering letter, Form MD-14 and fee challan
- Power of attorney from the overseas manufacturer and the authorised agent's undertaking, in the Part I format, authenticated in India by a Magistrate of the First Class, or by the Indian Embassy in the country of origin, or through apostille
- Copy of the authorised agent's wholesale licence, manufacturing licence or Form MD-42 registration certificate, and its constitution details
- Notarised free sale certificate or marketing authorisation from the regulator of the country of origin, and from the USA, UK, EU, Canada, Japan or Australia if available
- Notarised copy of the overseas manufacturing site or plant registration in the country of origin
- Latest inspection or audit report by a notified body, national regulator or competent authority from the last 3 years, if any
- Notarised Quality Management System certificate for the actual manufacturing site (for example ISO 13485), and the Full Quality Assurance, CE type examination, CE design or production quality assurance certificate as applicable, with the manufacturer's declaration of conformity
- Plant (site) Master File as per Appendix I of the Fourth Schedule
- Device Master File as per Appendix II (Appendix III for IVDs): device description, grouping justification, specifications and variants, labels and instructions for use, design and manufacturing information, Essential Principles checklist, risk analysis, verification and validation, biocompatibility, sterilisation and software validation where applicable, stability data for the claimed shelf life, clinical evidence if any, post-market surveillance data, and batch release certificates or certificates of analysis for at least three consecutive batches
- Undertaking that the manufacturing site complies with the Fifth Schedule
- For IVDs: the manufacturer's performance evaluation report
- For an investigational medical device: the permission in Form MD-27
If any document changes after you apply and before the licence is granted, you must inform the Central Licensing Authority in writing (rule 34(2)).
How to apply for the import licence online
- Confirm the device's class and whether it is a Class A non-sterile and non-measuring device (registration route) or a device already approved for another importer (subsequent importer route).
- Get the power of attorney from the overseas manufacturer and make sure the authorised agent holds a wholesale licence, manufacturing licence or Form MD-42 registration.
- Register on CDSCO's online portal for medical devices, cdscomdonline.gov.in. CDSCO's website refers to it as the SUGAM online portal.
- File Form MD-14 with the documents and the fee under the Second Schedule.
- CDSCO examines the application. It may inspect the overseas manufacturing site (rule 35), and if it has reason to believe quality is compromised it may have the device tested at a laboratory it specifies, at the authorised agent's cost (rule 34(3)).
- The Central Licensing Authority grants Form MD-15 or rejects the application with reasons within nine months of the application (rule 36(1)).
Subsequent importer: since 11 September 2025, the online portal has a separate provision for importing devices and IVDs already approved by the Central Licensing Authority, filed as per CDSCO's checklist for that purpose (CDSCO circular dated 15 September 2025).
Government fee for the import licence (Second Schedule, MDR 2017)
The fee is paid for each overseas manufacturing site and for each distinct device, as set out in the Second Schedule:
| Device | Fee per overseas manufacturing site | Fee per distinct device |
|---|---|---|
| Class A (other than non-sterile and non-measuring), other than IVD | US$ 1,000 | US$ 50 |
| Class B, other than IVD | US$ 2,000 | US$ 1,000 |
| Class C or Class D, other than IVD | US$ 3,000 | US$ 1,500 |
| Class A (other than non-sterile and non-measuring) or Class B IVD | US$ 1,000 | US$ 10 |
| Class C or Class D IVD | US$ 3,000 | US$ 500 |
- Inspection of an overseas manufacturing site, if CDSCO decides to inspect: US$ 6,000 (rule 35(2)).
- Test licence to import for test, evaluation, demonstration or training (MD-16 / MD-17): US$ 100 per distinct device.
- An application for an additional manufacturing site or an additional device at the same site carries the fee in the Second Schedule (rule 34(4)).
Timeline: the rules require a decision within nine months from the date of application (rule 36(1)). The actual time depends on CDSCO's scrutiny, queries and any inspection.
Validity, retention fee and post-licence conditions
An MD-15 licence remains valid in perpetuity unless it is cancelled or surrendered, provided the authorised agent pays the licence retention fee for each overseas manufacturing site and each licensed device after every five years from the date of issue (rule 37).
- The Central Licensing Authority may accept the retention fee after the due date, within 90 days, with a late fee of 2% per month.
- If the retention fee is not paid within that period, the licence is deemed cancelled.
| Retention fee item (every five years) | Fee |
|---|---|
| Each overseas site making Class A (other than non-sterile and non-measuring) devices, other than IVD | US$ 1,000 |
| Each overseas site making Class B devices, other than IVD | US$ 2,000 |
| Each overseas site making Class C or Class D devices, other than IVD | US$ 3,000 |
| Each distinct Class A (other than non-sterile and non-measuring) device, other than IVD | US$ 50 |
| Each distinct Class B device, other than IVD | US$ 1,000 |
| Each distinct Class C or Class D device, other than IVD | US$ 1,500 |
| Each overseas site making Class A (other than non-sterile and non-measuring) or Class B IVDs | US$ 1,000 |
| Each overseas site making Class C or Class D IVDs (see note) | US$ 3,000 |
| Each distinct Class A (other than non-sterile and non-measuring) or Class B IVD | US$ 10 |
| Each distinct Class C or Class D IVD | US$ 500 |
Note: the Second Schedule's wording for the US$ 3,000 IVD site entry reads 'Class C or Class D medical device other than in vitro diagnostic'. A draft amendment of December 2025 proposes to correct it to IVDs. Confirm the fee shown on the portal.
Conditions after the licence (rules 38, 39 and 44)
- Inform the licensing authority within 15 days of any administrative action abroad on account of adverse reaction, such as market withdrawal or cancellation of authorisation, and stop dispatch and marketing of that device.
- Get prior approval before any major change listed in the Sixth Schedule; if CDSCO does not decide within 60 days, the change is deemed approved. Inform minor changes within 30 days.
- Inform CDSCO within 30 days of any change in the constitution of the overseas manufacturer or the authorised agent. If the licensee's constitution changes, apply afresh within 180 days; the existing licence stays valid until the new one is issued or the application is rejected.
- Send each consignment with an invoice or statement of the name and quantity of the device, and supply it with its package insert or user manual.
- Label imported devices, by stickering if not already printed, with the import licence number, the importer's name and address, the address of the actual manufacturing premises and the date of manufacture (rule 44(n)).
Why Corpseed for the MD-14 / MD-15 import licence?
Corpseed checks the device class and the right route (MD-15, NSNM registration or test licence), prepares the power of attorney, Device Master File and Plant Master File with the manufacturer, and files Form MD-14, replies to queries, endorsements and retention on the CDSCO portal. CDSCO's Central Licensing Authority decides and grants the licence.
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Frequently Asked Questions
Quick answers to common questions about this service.
Who can apply in Form MD-14?
The authorised agent of the overseas manufacturer, appointed by power of attorney, who holds a licence to manufacture for sale or distribution, a wholesale licence, or a registration certificate in Form MD-42 (MDR rules 3(f) and 34(1)).
What is the difference between MD-14 and MD-15?
Form MD-14 is the application for an import licence. Form MD-15 is the import licence the Central Licensing Authority grants (MDR rules 34 and 36).
Does every imported medical device need an MD-15 licence?
No. Class A non-sterile and non-measuring devices are registered on the Online System for Medical Devices instead (rules 19J-19K). Devices imported only for test, evaluation, clinical investigation, demonstration or training need a test licence (MD-16 / MD-17).
What is the government fee for an import licence?
It is in US dollars, per overseas site and per distinct device, depending on class. For example, a Class C or D device (other than IVD) costs US$ 3,000 per site and US$ 1,500 per device (MDR Second Schedule). The full table is in the Fees tab.
How long is an MD-15 import licence valid?
It is valid in perpetuity unless cancelled or surrendered, if the retention fee is paid after every five years for each site and each device. Late payment within 90 days attracts 2% per month; after that the licence is deemed cancelled (rule 37).
How long does CDSCO take to decide?
Rule 36(1) requires the Central Licensing Authority to grant or reject the application within nine months from the date of application.
Is a clinical investigation needed for import?
Not if a free sale certificate has been issued by the regulator of Australia, Canada, Japan, an EU country, the UK or the USA (rule 36(3)). Otherwise, Class C and D devices may need a clinical investigation in India (rule 36(4)).
Where is the application filed?
Online on CDSCO's portal for medical devices, cdscomdonline.gov.in.
Can I add more devices to my existing import licence?
Yes, through an endorsement application in Form MD-14 with the fee and documents for each additional device or site (rule 34(4); CDSCO checklist). See our MD-14 endorsement page.
Another company already imports the same device. Can we import it too?
Since 11 September 2025, CDSCO's online portal has a separate subsequent importer provision for devices and IVDs already approved by the Central Licensing Authority (CDSCO circular, 15 September 2025).
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