Exporting medical devices, in vitro diagnostics, cosmetics, and other medical products to India often brings with it a sense of fear for both sides (manufacturer and distributor). On one hand, overseas manufacturers hear from their Indian distributors that everything is simple and on the other hand, once the goods arrive at an Indian port, the local partner starts sending high-pressure emails and phone calls, urgently requesting additional documentation.
This gap is no one’s fault. It is primarily due to a lack of awareness and experience in navigating the complexities of the CDSCO customs clearance process. This is exactly where Morulaa HealthTech steps in as a specialized CDSCO license consultant for medical devices. We stay constantly updated on Indian import requirements and focus on strong documentation before the goods leave the country of origin, thereby avoiding delays, penalties, and unnecessary costs.
Why Leading Manufacturers and Distributors Prefer Morulaa
In the last few years, both overseas manufacturers and their Indian distributors have increasingly preferred to route their medical devices through Morulaa, using us as the authorised agent holding the CDSCO medical device import license (MD Form 15).
Why?
Because in the long run, this approach:
- Reduces shipping cost
- Minimizes demurrage charges
- Ensures the correct custom duty on medical equipment in India
- Cuts down clearance delays
Common Pitfalls to Avoid When Exporting Medical Devices to India
Here are the key areas every medical device exporter should be aware of:
1. Matching Invoice Name and Address
The manufacturer’s name and address, consignee’s name, and consignee’s address on the invoice must exactly match the details on the medical device import license India (MD Form 15) and legal manufacturer records used during the device registration in India.
2. Consistent Product Name and Model Number
The product name and model number must be identical across the invoice, packing list, product label, and CDSCO medical device import license. When filing the MD Form 15 application, the authorised Indian agent must verify a sample invoice and product label to ensure the data matches the form submitted to the Sugam Portal.
3. Shelf Life Accuracy
The shelf life recorded during CDSCO registration certificate submission must match what’s stated on the shipment documents. Any changes to the shelf life must be notified in advance to the CDSCO and approved before shipment. Otherwise, the goods risk being held in bonded warehouses until approval is granted.
4. Residual Shelf Life
The residual shelf life (remaining shelf life at the time of import) must comply with Indian regulatory requirements. Upon landing, the ADC form must be filled out with the manufacturing date, expiry date, and landing date to calculate and confirm the residual shelf life.
5. ADC Clearance
Apart from standard customs and duty processes, medical products also require ADC (Assistant Drug Controller) clearance. An ADC officer physically verifies the shipment documents and compares them to the actual boxes, sometimes including manual inspection of product labeling.
6. Demurrage Charges
If clearance is delayed, demurrage charges apply which depend on the packaging and space requirement. This makes it critical to ensure all documents are 100% accurate and ready before the shipment arrives.
7. Importer Label Compliance
Medical devices imported into India must display an importer label containing:
- Importer Details
- Import License Number (as per the CDSCO medical device import license)
- Month/ Year of Import
- Maximum Retail Price (MRP)
8. Maximum Retail Price (MRP)
An MRP must be added to the importer label per Legal Metrology Requirements. It’s also important to note that MRPs can only increase by 10% per year and any changes must be reported to the NPPA.
9. Evolving Regulatory Requirements
India is introducing new rules related to plastic waste and electronic waste recycling. These requirements now affect medical device labels, so exporters must stay informed and compliant.
How to Import Medical Devices in India with Morulaa HealthTech
At Morulaa HealthTech, we ensure:
- High compliance standards
- Quick turnaround times
- Full 4PL services to medical device and IVD manufacturers
We provide expert guidance on how to import medical devices in India, from documentation to navigating the CDSCO customs clearance process, ensuring your goods move smoothly from the home country of origin to the Indian customer—avoiding mistakes and keeping your supply chain efficient.