If you’re planning to import medical supplies from the USA to India, it’s important to understand the legal steps, license, and documents required before your goods reach Indian ports. India has strict rules for healthcare and medical imports to ensure safety, quality, and transparency, and transparency in the market. Even if you’re importing medical devices, surgical items, or diagnostic kits, there are government regulations you should follow, like CDSCO registration, LMPC certification, and customs clearance procedure. All the steps are important to avoid delays, penalties, or rejection of your shipment. Through this article, we will help you with everything you need to know.
Types Of Medical Supplies You Can Import From the USA to India
India allows the import of a wide range of medical supplies from the USA, especially due to the growing demand for advanced healthcare products and technologies. These medical supplies range from basic consumables to high-end diagnostic and therapeutic equipment.
- Medical Device
- Consumable Medical Supplies
- Hospital Furniture and Fixtures
- Laboratory Equipment and Diagnostic Kits
- Dental and Orthopedic Suppliers
- Medical Software and Electronic Health Systems
- Sterilization and Disinfection Products
- Implants and Surgical Implants
Regulatory Bodies Governing Medical Supplies Import In India
Importing medical supplies into India is governed by several regulatory authorities to ensure that the products are safe, effective, and meet national quality standards. Each authority plays a different role based on the type of product being imported, even if it’s a medical device, pharmaceutical, or healthcare equipment.
- Central Drug Standard Control Organization
- Legal Metrology Department
- Bureau of Indian Standards
- Atomic Energy Regulatory Board
- Directorate General of Foreign Trade
- Customs Department
Licenses Required To Import Medical Supplies From the USA to India
If you’re planning to import medical supplies from the USA to India. It’s important to understand what licenses and registration you need before your goods arrive. The Indian government has set clear guidelines to make sure all medical items entering the country are safe, properly labeled, and legally approved.
- Import Export Code
- CDSCO Import License
- LMPC Certificate (Legal Metrology Certificate)
- BIS Certification
- AERB NOC (For Radiation-Based Equipment
- Product Specific Licenses
Step-by-Step Process To Import Medical Supplies From the USA To India
Here we have listed all the easy steps to import medical supplies from the USA to India:
- Identify the medical supplies you want to import – Check if the medical supplies fall under the list of notified medical devices by the CDSCO. Classify them correctly (Class A, B, C, and D) as per Indian medical device rules.
- Obtain an Import Export Code – IEC is mandatory for anyone wishing to import goods into India. Apply online via the DGFT portal.
- Apply for a CDSCO Import License – Required if you are importing notified medical devices. Submit form MD 14, MD 15, MD 16, MD 17, depending on device class. Apply on the SUGAM portal.
- Register for the LMPC Certificate – As per the Legal Metrology Packaged Commodities Rules, 2011, importers should have an LMPC certificate for packaged medical goods. Apply to your state’s legal metrology department.
- Check for Additional Licenses – For radiation-based devices, get AERB NOC. For products under a mandatory quality standard, get BIS certification.
- Book shipment and prepare shipping documents – Use a reliable freight forwarder. Ensure documents are ready.
- Customs clearance at an Indian port – Submit all documents to Indian customs. Pay applicable customs duties and GST.
Documents Required To Import Medical Supplies From the USA To India
Here we have mentioned the list of required documents to import medical supplies from the USA to India:
- Import Export Code
- Commercial Invoice
- Packaging List
- Bill of Lading/Airway Bill
- Purchase Order or Agreement
- Certificate of Origin
- Insurance Certificate
- Freight Invoice
- Customs Declaration Form/Bill of Entry
- GST Registration Certificate
- PAN Card
- CDSCO Import License
- Free Sale Certificate
- Device Master File
- Test Report or Clinical Data
- Label and Packaging Artwork
- LMPC Certificate
CDSCO Registration For Importing Medical Supplies from the USA To India
CDSCO Registration is a legal approval required if you are planning to import medical supplies from the USA to India. It is issued by the Central Drug Standard Control Organization, which is the main regulatory authority for medical devices and drugs in India.
Customs Clearance Procedure For Medical Supplies Import To India
If you want to import medical supplies into India, understanding the customs clearance process is very important. This step ensures that your goods are legally permitted to enter the country and comply with all relevant health and safety regulations.
- Arrival of Goods at Port
- File Bill of Entry
- Submit all the Required Documents
- Customs Duty Payment
- Customs Inspection
- Clearance and Delivery
Cost Involved In Importing Medical Supplies From the USA To India
When importing medical supplies from the USA to India, several types of costs are involved, apart from just the product price.
- Product Cost
- Freight Charges
- Customs Duties and GST
- CDSCO Registration Cost
- LMPC Certificate Charges
- Customs Clearance Fees
- Inspection or Lab Testing
- Storage or Handling Charges
Challenges Faced While Importing Medical Supplies From the USA to India
Importing medical supplies from the USA to India may seem straightforward, but there are several real challenges that importers often face.
- Regulatory Approvals
- Incorrect Product Classification
- Incomplete Documentation
- Labeling Compliance
- High Customs Duties
- Inspection Delays
- Lack of Local Knowledge
Why Choose ELT Corporate For Medical Supplies Import Consultancy?
Importing medical supplies into India involves strict regulation, approvals, and timely documentation. ELT corporate, one of the best regulatory consultancies in India, makes this process smooth, fast, and compliant.
- Expert support for CDSCO & LMPC registrations
- Accurate documentation & Form Filing
- End-to-end guidance from product classification to custom clearance
- Fast turnaround time with proactive follow-up
- 2500+ successful regulatory licenses delivered
- PAN India Service Coverage
- Affordable & transparent pricing
You can directly call at 9899997002 or email at info@legalmetrologyindia.com.
Is CDSCO Registration Mandatory To Import All Types of Medical Supplies From the USA to India?
This may vary as only notified medical devices require CDSCO registration; other products may not, however, it should still meet labeling and packaging rules.
How Long Does It Take To Import Medical Supplies Into India?
Basically import process usually takes 7 to 15 working days, depending on documentation, approvals, and customs clearance.
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