If you’re planning to import medical equipment from China to India, you should follow the right legal steps and documentation as per Indian regulations. The CDSCO has made it mandatory for importers to get proper registration and licensing to make sure that only safe and certified medical devices reach indian hospitals, clinics, and markets. Check this article to learn how the Import medical equipment from China to India.
What is Required To Import Medical Equipment From China to India?
To import medical equipment from China into India, you should follow the rules and procedures set by the CDSCO under the Medical Device Rules, 2017. The Indian government wants to make sure that all imported medical devices are safe, properly tested, and meet indian quality standards.
- CDSCO Registration – Form MD-14, Form MD-15
- Authorized Indian Agent – Valid wholesale license
- Importer’s Wholesale License – Form 20B & 21B or MD-42
- Required Documents
- Product Labeling as per Indian Rules
- Use the CDSCO SUGAM Portal
Is CDSCO Registration Mandatory to Import Medical Equipment From China?
Yes, CDSCO registration is necessary if you want to import medical equipment from China into India, but only if the medical equipment you are importing is classified as a notified medical device, under the Medical Device Rules, 2017, issued by the CDSCO.
Do You Know When CDSCO Registration is Mandatory?
Basically CDSCO registration is required only for those medical dveice that are notified by the Indian government. These are devices that impact human health, and the government has included them in the official notification list under the medical device rules.
- The product is listed in the CDSCO Notified Medical Device List
- The product is used for diagnosis, treatment, monitoring, or prevention of a disease or condition
- The product falls under Class A, B, C, and D
What Licenses Are Needed to Import Medical Equipment From China to India?
To import medical equipment from China to India, you need to follow specific licensing and regulatory requirements, especially if the products are classified as medical devices.
- CDSCO Import License (Form MD 15)
- Wholesale Drug License
- Importer Exporter Code
- Goods and Services Tax (GST) Registration
- BIS Registration
- Legal Metrology Registration
How to Classify the Medical Equipment Before Importing From China?
Here you can check out the table to know how to classify medical equipment before importing from China:
| Step | Classification Factor | What It Means | How It Affects the Import Process |
|---|---|---|---|
| 1. | Is it a Medical Device | First, check if the requirements are listed as a notified medical device by CDSCO | Only notified devices need CDSCO registration. Non-notified may not need an import license |
| 2. | Intended Use of the Device | What is the purpose of the device? Diagnosis, treatment, monitoring, etc? | Determines the risk class (A, B, C, D) Higher the risk, the stricter the regulation |
| 3. | Risk Classification (A, B, C, D) | Based on the intended use, invasiveness, and duration of the contact with the body. | Impacts the types of documentation and approval required |
| 4. | Is it Invasive or Non-Invasive? | Does the device go inside the body (like catheters) or stay external (like BP monitors)? | Invasive devices usually fall under higher risk classes |
| 5. | Duration of Use | Is the device used for <60 min (short-term), <30 days, or permanently? | Longer duration – higher risk – stricter requirements |
| 6. | Contact with the Human Body | Is the contact surface tissue, blood, or internal organs | Deep contact increases classification to class C or D |
| 7. | Electric/Electronic Equipment? | Does the device use electricity or batteries? | May also require BIS certification in India |
| 8. | Software Driven | Is it a software-based diagnostic or medical equipment | Software-based devices may fall into class B or C, depending on use |
| 9. | Standalone or part of a System | Is it a component accessory, or a full system | Some accessories are regulated differently from main devices |
| 10. | Check the CDSCO guidance Documents | Use the CDSCO classification rules and guidance manual for final classification | Help avoid errors and delays during submission |
What is the Procedure to Import Medical Equipment from China to India?
Check the list to know the procedure to import medical equipment from China to India:
Classify the Medical Equipment
- Check if the device is a notified medical device under the CDSCO
- Identify its risk class (A, B, C, D) based on its use, safety, and contact with the human body
Appoint an Indian Authorized Agent
- A foreign manufacturer should appoint authorized agent in India who is licensed and registered with CDSCO
- The agent will represent the company for all regulatory communication
Get CDSCO Registration
- Registration Certificate (Form MD-14)
- Import License (Form MD-15)
- Submit documents like Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate (FSC), Power of Attorney, etc.
Get an Importer Wholesale License
- The indian importers also need a wholesale drug license (Form 20B/21B) from the state drug authority.
Follow Labeling Rules
- Ensure product packaging has proper labels, including:
- Importer name & address
- MRP
- Date of Manufacturer
- CDSCO Registration Number
- Manufacturer Details
Custom Clearance
- Once all approvals are in place:
- Import the equipment via Indian ports
- File the Bill of Entry
- Submit documents like CDSCO license, Invoices, Shipping bill, etc
- Pay applicable customs duty and taxes
After Sales Compliance
- Maintain records of batch number, sales, and complaints
- Ensure post-market surveillance and customer support
What are The Documents Required to Import Medical Equipment From China to India?
Here is the list of documents required to import medical equipment from China to India:
If the Device is a notified Medical Device then check this list:
- Cover Letter
- Power of Attorney
- Free Sale Certificate
- Device Master File
- Plant Master File
- CE Certificate or ISO 13485
- Clinical Evaluation Report
- Undertaking & Declarations
- CDSCO Portal Login Credentials
For Importer (Indian Entity)
- Wholesale Drug License (Form 20B/21B)
- Importer’s GST Certificate
- Company PAN Card
- IEC (Import Export Code)
- Authorized Signatory ID Proof
For Customs Clearance
- Bill of Entry
- Packing List
- Commercial Invoice
- Air Waybill or Bill of Lading
- CDSCO Registration Copy
- Label Sample
Common Mistakes To Avoid While Importing Medical Equipment From China
Here are the typical mistakes importers should avoid while importing medical equipment from China:
- Not checking if the device is CDSCO notified
- Incorrect device classification
- Missing or unverified free sale certificate
- Improper or missing labeling
- Power of attorney not apostilled
- No valid wholesale license with the importer
- Shipping before CDSCO registration is granted
- Missing before the CDSCO registration is granted
- Missing customs documentation
- Ignoring post-import compliance
How Long Does It Takes To Get Approval For Importing Medical Equipment From China?
The approval process to import medical equipment from China to India usually takes 4 to 5 months, based on the equipment.
Why Choose ELT Corporate for Medical Equipment Import Registration In India?
Importing medical equipment into India requires proper licenses, documents, and approvals from the CDSCO. Without expert help, the process can get confusing and cause delays. Here, ELT Corporate, the best regulatory consultancy in India, will help in every step:
- Expertise in CDSCO Compliance
- Complete End-to-End Support
- Faster Approvals Process
- Accurate Technical Documentation
- Approved Indian Authorized Agent Service
- Affordable and Transparent Pricing
- Dedicated Account Manager
Directly call us at 9899997002 or email us at info@medicaldeviceregistration.com.
What is the Full Form of CDSCO?
CDSCO stands for Central Drug Standard Control Organization, and it is the national regulatory authority.
What Ports Can Ve Used To Import Medical Equipment Into India?
Medical equipment can be imported through major ports like Mumbai, Chennai, Delhi, and Kolkata, which are equipped with CDSCO-appointed customs authorities.
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