How to Import Medical Devices from China to India 2026 Guide | BEFACH International
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How to Import Medical Devices from China to India: CDSCO Guide 2025
February 21, 2026
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How to Import Medical Devices from China to India: CDSCO Guide 2025
How to Import Medical Devices from China to India: Complete Compliance Guide 2026
How to Import Medical Devices from China to India: Complete Compliance Guide 2026
Price: USD 50-5000 per unit | HS Code: 9018-9022 | BCD: 0-7.5%, IGST: 12-18%, SWS: 10%
India's healthcare import sector operates under strict regulatory oversight. If your business is exploring how to import medical devices from China to India, understanding the CDSCO registration process, DGFT licensing requirements, and customs duty structure is essential for successful clearance. Whether you're importing diagnostic equipment, surgical instruments, or electronic patient monitoring systems from Chinese manufacturers, compliance with Indian medical device regulations determines your market entry success.
How to Import Medical Devices from China to India: Regulatory Updates
The Central Drugs Standard Control Organization (CDSCO) and Directorate General of Foreign Trade (DGFT) have streamlined the import authorization process for medical devices under the Medical Devices Rules, 2017. Recent amendments focus on enhancing quality control while facilitating legitimate trade from Chinese suppliers.
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Updated CDSCO registration requirements for Class A, B, C, and D devices
Revised labeling and language specifications for imported medical equipment
Strengthened post-market surveillance obligations for Chinese manufacturers
Key Update: The import policy now mandates unique device identification (UDI) compliance for high-risk medical devices, aligning India's regulatory framework with international standards while maintaining strict oversight on Chinese-origin healthcare products.
Why Import Compliance Matters for Your Business
Medical devices imported from China fall under restricted or regulated categories depending on their risk classification. The Indian government controls these imports through specific licensing requirements, meaning you cannot clear shipments without proper CDSCO registration and DGFT import authorization.
If your operations involve:
Hospital equipment supply chains
Diagnostic laboratory setups
Retail pharmacy distribution
E-commerce healthcare sales
You must follow the complete process for how to import medical devices from China to India, or risk shipment detention at port, CDSCO blacklisting, and significant financial penalties.
Import Duty Structure for Chinese Medical Devices (2026)
Component
Rate
Applies To
Basic Customs Duty (BCD)
0-7.5%
Assessable value of medical devices
Integrated GST (IGST)
12% or 18%
(Assessable Value + BCD + SWS)
Social Welfare Surcharge (SWS)
10% on BCD
Calculated on BCD amount
Total Effective Duty
13.2-28.25%
On CIF value
Pro Tip: When calculating how to import medical devices from China to India cost-effectively, always use the CIF (Cost, Insurance, Freight) value as your duty base. The IGST applies to the sum of assessable value, BCD, and SWS—not just the base value. Certain life-saving devices may qualify for concessional BCD rates with proper Ministry of Health certification.
Compliance Requirements You Must Meet
1. CDSCO Registration Certificate
Obtain import registration from CDSCO under the Medical Devices Rules, 2017. Each device category (from surgical gloves to MRI machines) requires specific registration documentation and manufacturing site verification for Chinese facilities.
2. Import License (MD-15)
Secure Form MD-15 (Import License) from the CDSCO state licensing authority. This authorization is device-specific and valid only for the registered Indian importer, not transferable to other entities.
3. BIS Certification (if applicable)
Electronic medical devices imported from China require Bureau of Indian Standards (BIS) certification under the Compulsory Registration Scheme (CRS). This includes patient monitors, infusion pumps, and diagnostic ultrasound equipment.
4. Country of Origin Marking
Ensure all packages display "Made in China" markings as per Customs notification. Failure to provide proper country of origin documentation results in immediate customs holds and potential anti-dumping duty assessments.
5. Customs Documentation
File your Bill of Entry with:
CDSCO Import License (MD-15) copy
Manufacturing license from Chinese authorities
Free Sale Certificate from China
Device master file and plant master file
ISO 13485 certificate from the manufacturer
Cost Breakdown Example
For a hypothetical import of diagnostic equipment valued at ₹10,00,000 CIF:
Cost Component
Calculation
Amount (INR)
CIF Value
Base value
₹10,00,000
Basic Customs Duty (7.5%)
7.5% of ₹10,00,000
₹75,000
Social Welfare Surcharge (10% on BCD)
10% of ₹75,000
₹7,500
IGST Base
₹10,00,000 + ₹75,000 + ₹7,500
₹10,82,500
IGST (18%)
18% of ₹10,82,500
₹1,94,850
Total Landed Cost
₹10,00,000 + all duties
₹12,77,350
Watch Out: Delays in CDSCO documentation can result in demurrage charges at port, which for sensitive medical equipment requiring climate-controlled storage can escalate quickly. Always pre-file your import license before the shipment departs Shanghai or Shenzhen.
Where to Access Official Documentation
CDSCO Medical Device Portal: https://cdsco.gov.in/
DGFT Import Policy: https://dgft.gov.in/
BIS Certification Portal: https://www.bis.gov.in/
FAQ: How to Import Medical Devices from China to India
Q1: What is the first step in how to import medical devices from China to India?
A: The first step is obtaining CDSCO registration for the specific device category. You must submit manufacturing site details, device specifications, and quality management system certificates to the CDSCO online portal before applying for the import license.
Q2: Do all medical devices from China require BIS certification?
A: No, BIS certification applies primarily to electronic medical devices and in-vitro diagnostic equipment under the Compulsory Registration Scheme. Non-electronic devices like surgical instruments and disposable syringes typically do not require BIS registration but need CDSCO import licenses.
Q3: How long does the complete import authorization process take?
A: The timeline for how to import medical devices from China to India typically ranges from 6 to 9 months. CDSCO registration takes 4-6 months, followed by Import License (MD-15) processing for 30-60 days. Plan your inventory accordingly to avoid stock shortages.
Q4: Are there additional restrictions or duties on Chinese medical devices specifically?
A: While there are no country-specific additional duties solely for Chinese medical devices, certain product categories face anti-dumping duties. Always verify current AD duty notifications on the CBIC website for specific devices like digital thermometers or pulse oximeters from China.
Q5: Can I import medical devices from China for personal use?
A: No, personal import of medical devices is prohibited. Only authorized distributors, hospitals, and medical institutions with valid CDSCO import licenses and wholesale drug licenses can legally import medical devices into India.
Next Steps for Importers
Verify device classification—determine if your product falls under Class A, B, C, or D to understand specific licensing timelines
Appoint an Authorized Agent in China to facilitate manufacturing site inspections required by CDSCO
Prepare technical documentation including clinical evaluation reports and biological safety assessments
Register on the CDSCO online portal to track your application status in real-time
Need help navigating how to import medical devices from China to India efficiently? Our DGFT licensing services and customs clearance support can streamline your CDSCO registration process and ensure full regulatory compliance for Chinese medical imports.
