India is one of the world’s fastest-growing markets for affordable and innovative medical devices. Chinese companies dominate the global supply chain due to their strong manufacturing capabilities, cost efficiency, and advanced R&D. However, before any Chinese manufacturer can export medical devices to India, they must obtain CDSCO import registration through the MD-15 license.
The CDSCO MD-15 License for Chinese medical device importers ensures that all imported devices are safe, effective, and meet Indian quality requirements. Without this license, Indian customs will not release imported devices.
What Is the CDSCO MD-15 License for Chinese Medical Device Importers?
The CDSCO MD-15 License for Chinese medical device importers is an official import license issued under the Medical Device Rules (MDR) 2017. It is mandatory to import any Class A, B, C, or D medical device manufactured in China.
This license is always issued to an Indian Authorised Agent or importer, but the Chinese manufacturer must provide all technical documents required for CDSCO registration.
Who Needs the CDSCO MD-15 License for Chinese Medical Device Importers?
This license is required by:
- Indian importers sourcing medical devices from China
- Indian distributors bringing Chinese devices to the market
- Authorised Agents appointed by Chinese manufacturers
- Chinese manufacturers exporting devices to India
Any device—small or complex—requires the CDSCO MD-15 License for Chinese medical device importers for legal entry into India.
Device Classification for Chinese Medical Devices
Before applying for the CDSCO MD-15 License for Chinese medical device importers, the device must be classified:
- Class A – Low risk (e.g., digital thermometers, goggles)
- Class B – Low–moderate risk (e.g., needles, suction catheters)
- Class C – Moderate–high risk (e.g., infusion pumps, ventilators)
- Class D – High risk (e.g., pacemakers, heart valves)
Correct classification is extremely important because the CDSCO registration process, timeline, and document requirements depend on the device class.
Documents Required for CDSCO MD-15 License for Chinese Medical Device Importers
Chinese manufacturers must provide complete documentation to the Indian importer or Authorized Agent. Documents include:
- Free Sale Certificate / Certificate of Legal Sale / Export Certificate issued by the Chinese regulatory authority
- Manufacturing license
- ISO 13485 certificate
- Device Master File (DMF)
- Plant Master File (PMF)
- Clinical data (for Class C & D)
- Test reports
- Biocompatibility reports
- Sterilization validation (if applicable)
- Labels and artwork
- Authorized Agent agreement
- Declaration of conformity
- Stability and performance data
These documents are essential for applying for the CDSCO MD-15 License for Chinese medical device importers on the CDSCO Sugam portal.
Step-by-Step CDSCO Registration Process for Chinese Medical Device Importers
Step 1: Appoint an Authorized Agent in India
Only an Indian company can apply for the CDSCO MD-15 License for Chinese medical device importers.
Step 2: Create Manufacturer and Importer Profiles
The importer registers the Chinese manufacturer on the CDSCO portal.
Step 3: Prepare Technical File
The Chinese manufacturer provides DMF, PMF, test reports, and FSC.
Step 4: Submit Form MD-14
The importer files Form MD-14 for the import license request.
Step 5: Pay Government Fees
Fees depend on device class and number of models.
Step 6: CDSCO Evaluation
CDSCO reviews safety documents, performance data, and certificates.
Step 7: Grant of MD-15 License
Once approved, CDSCO issues the CDSCO MD-15 License for Chinese medical device importers, allowing legal import and sales in India.
Timeline for CDSCO MD-15 License for Chinese Medical Device Importers
The average timeline:
- Document preparation: 2–4 weeks
- CDSCO review: 3–6 months
- Approval: Depends on device class and queries
Most applications are cleared within 3–6 months.
Cost of CDSCO MD-15 License for Chinese Medical Device Importers
Cost depends on:
- CDSCO government fee
- Testing (if required)
- Document notarization
- Consultancy charges
- Number of manufacturers
- Number of models
Higher-class devices (Class C & D) usually have higher costs.
Labeling Requirements for Chinese Medical Device Importers
To obtain the CDSCO MD-15 License for Chinese medical device importers, labeling must follow all Indian rules:
- Name and address of importer
- Name and details of Chinese manufacturer
- Device class
- Batch/lot number
- Serial number
- Storage conditions
- Manufacturing and expiry dates
- Instructions for use
Incorrect labeling can lead to delays or license rejection.
Why Chinese Medical Device Companies Choose the Indian Market?
- High demand for affordable devices
- Large healthcare expansion
- Government push for modern diagnostics
- Opportunity for long-term growth
- Acceptance of Chinese technology in India
The CDSCO MD-15 License for Chinese medical device importers helps ensure smooth legal access to this growing market.
Do Chinese manufacturers need CDSCO approval?
Yes, they must obtain the CDSCO MD-15 License for Chinese medical device importers through an Indian Authorized Agent.
Can a Chinese company apply directly?
No, the application must be submitted by an Indian importer.
How long is the MD-15 license valid?
It is valid indefinitely as long as the retention fee is paid every 5 years.
Are Chinese test reports accepted?
Yes, but only if issued by recognized laboratories and translated into English if needed.
Is clinical data mandatory?
Required for Class C and D devices; optional for Class A and B.
Can one importer bring multiple Chinese manufacturers into India?
Yes, if they hold separate approvals.
Does CDSCO conduct plant inspections in China?
CDSCO may conduct an inspection for high-risk devices.
Comments are closed