Korea is one of the world’s fastest-growing medical device hubs. But before any Korean company can sell devices in India, it must get the CDSCO MD-15 License for Korean medical device manufacturers. This license is mandatory for importing any Class A, B, C, or D medical device into India. Without the CDSCO MD-15 License for Korean medical device manufacturers, customs will not clear the shipment, and the importer cannot legally distribute devices in India. This guide explains the process in simple words so Korean manufacturers and their Indian partners can easily follow every step of CDSCO India’s rules.
What Is the CDSCO MD-15 License for Korean Medical Device Manufacturers?
The CDSCO MD-15 License for Korean medical device manufacturers is the official import license issued to an Indian importer or authorised agent for bringing Korean medical devices into India. This license is required under the Medical Device Rules (MDR), 2017 and must be obtained before any shipment arrives in India. MD-15 is mandatory for importing all Class A, B, C, and D medical devices into India, including sterile, non-sterile, measuring, and non-measuring devices. All imported devices must follow the MD-14 → MD-15 route under MDR 2017. To obtain the MD-15 license, the Indian Authorised Agent creates the Korean manufacturer’s profile on the CDSCO portal and submits the MD-15 application.
Who Needs the CDSCO MD-15 License for Korean Medical Device Manufacturers?
The license is required for:
- Korean manufacturers exporting devices to India
- Indian importers who want to bring Korean devices into India
- Authorised Agents working on behalf of Korean companies
- Distributors importing directly from Korea
Whether the device is simple (e.g., basic diagnostic accessories) or advanced (e.g., ultrasound systems)
Device Classification: The First Step Before Applying for CDSCO MD-15 License
Korean companies must classify their devices according to the CDSCO India rules:
- Class A – Low risk
- Class B – Low–moderate risk
- Class C – Moderate–high risk
- Class D – High risk
CDSCO classification may differ from the Korean MFDS classification. The correct class must be identified before preparing documents for the CDSCO MD-15 License for Korean medical device manufacturers.
Documents Required for CDSCO MD-15 License for Korean Medical Device Manufacturers
A Korean company must prepare the following documents for the CDSCO MD-15 License for Korean medical device manufacturers:
- Free Sale Certificate (FSC) issued by MFDS
- Manufacturing License
- Quality system certificate (ISO 13485)
- Device Master File (DMF)
- Plant Master File (PMF)
- Test reports as per ISO / IEC standards, performance evaluation data
- Performance evaluation data
- Clinical data (for Class C & D)
- Labels & artwork
- Undertaking of authenticity
- Authorised Agent agreement with the Indian importer
These documents form the core of the application processed through the CDSCO online Sugam portal.
Step-by-Step Process: How Korean Manufacturers Can Get CDSCO MD-15 License
Here is the complete process in simple steps:
Step 1: Appoint an Authorised Indian Agent
Korean companies must appoint a licensed Indian company to apply for the CDSCO MD-15 License for Korean medical device manufacturers.
Step 2: Prepare Technical Documentation
The Korean manufacturer must prepare DMF, PMF, ISO certificates, test data, and other documents.
Step 3: Register the Manufacturer Under CDSCO
The Authorised Agent creates a manufacturer profile on the CDSCO portal.
Step 4: Submit Form MD-14
The Indian importer submits Form MD-14 to request the CDSCO MD-15 License for Korean medical device manufacturers.
Step 5: Pay the CDSCO Government Fee
Fees depend on device category and the number of models.
Step 6: CDSCO Evaluation Stage
CDSCO reviews technical documents, stability data, device safety reports, and test certificates.
Step 7: Grant of MD-15 License
After a successful evaluation, CDSCO issues the CDSCO MD-15 License for Korean medical device manufacturers.
This license allows legal import and sales of Korean devices across India.
Timeline for CDSCO MD-15 License for Korean Medical Device Manufacturers
The usual timeline is:
- Preparation & documentation – 2 to 4 weeks
- CDSCO review – 3 to 6 months
- Approval & license grant – Depends on class and queries
Total time: 3 to 6 months, depending on complexity and device class.
Cost of CDSCO MD-15 License for Korean Medical Device Manufacturers
The cost includes:
- CDSCO government fee
- Technical documentation fee
- Consultancy fee
- Testing (if required)
- Legalisation or notarization of Korean documents
The total cost varies based on the number of models and device class.
Labelling Rules Korean Manufacturers Must Follow
Before applying for the CDSCO MD-15 License for Korean medical device manufacturers, all labels must follow Indian rules:
- Importer details (name & address)
- Manufacturing details
- Medical device class
- Storage conditions
- Batch number and serial number
- Manufacturing date & expiry date
Improper labelling causes delays or license rejection.
Why Korean Companies Prefer the CDSCO MD-15 License Route
Korean brands choose India because of:
- Fastest-growing medical device market
- High demand for advanced Korean technology
- Strong acceptance of Korean diagnostic and imaging devices
- Business-friendly import structure
The CDSCO MD-15 License for Korean medical device manufacturers makes entry into India smooth, legal, and compliant.
Do Korean manufacturers need CDSCO approval before exporting to India?
Yes, they must obtain the CDSCO MD-15 License for Korean medical device manufacturers through their Authorised Agent in India.
Can a Korean company apply for MD-15 directly?
No, only an Indian Authorised Agent can apply.
Is clinical data required?
For Class C and D devices, yes. For Classes A and B, only basic safety data is required.
How long is the MD-15 license valid?
It remains valid as long as the retention fee is paid every 5 years.
Do Korean cosmetic devices also need MD-15?
Only medical devices, not cosmetics. Cosmetics follow Form COS-1 or COS-2.
Can one Authorised Agent import multiple Korean manufacturers?
Yes, if they have the appropriate licenses.
What happens if documents are not in English?
They must be translated and notarised before submission.
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