Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is understanding the associated registration and import license fees. These fees vary based on the classification of your device and the nature of your operations. This guide provides a detailed overview to help you navigate the financial aspects of the regulatory process.
CDSCO Registration Fees for Medical Devices
The registration process involves several key fees:
Manufacturing Premises Registration: A fee of USD 1,500 (or its equivalent in Indian Rupees) is required for registering the manufacturing premises where the medical devices intended for import into and use in India are produced.
CDSCO
Single Device Registration: A fee of USD 1,000 (or its equivalent in Indian Rupees) is applicable for registering a single medical device intended for import into and use in India.
CDSCO
Additional Device Registration: An additional fee of USD 1,000 (or its equivalent in Indian Rupees) is charged for each additional medical device under the same application.
CDSCO
Inspection Fee: If required, an inspection fee of USD 5,000 (or its equivalent in Indian Rupees) may apply for the inspection or visit of the manufacturing premises.
CDSCO
These fees are to be paid through a TR-6 Challan at designated branches of Bank of Baroda, or via Electronic Clearance System (ECS) for payments made from abroad. The payment should be credited under the Head of Account:
CDSCO
License Fees for Medical Devices
For importing medical devices into India, the following fees are applicable:
Import License Application (Form 40): A fee of USD 1,500 (or its equivalent in Indian Rupees) is required for the application for an import license.
Single Device Registration: A fee of USD 1,000 (or its equivalent in Indian Rupees) is applicable for registering a single medical device for import.
CDSCO
Additional Device Registration: An additional fee of USD 1,000 (or its equivalent in Indian Rupees) is charged for each additional medical device under the same application.
CDSCO
Inspection Fee: If required, an inspection fee of USD 5,000 (or its equivalent in Indian Rupees) may apply for the inspection or visit of the manufacturing premises.
CDSCO
Import licenses are typically valid for three years, aligning with the validity of the registration certificate. Renewal applications should be submitted in advance to ensure continuous compliance.
Note: Fees are subject to change based on regulatory updates from CDSCO and currency exchange rates. It’s advisable to check the latest fee structure before submission.
Key Points to Remember CDSCO Registration & Import Licensing
Separate Applications: Each medical device requires a separate application and corresponding fee.
Payment Methods: Fees can be paid via bank challan or ECS, depending on the location of the applicant.
Validity Periods: Registration certificates and import licenses have specific validity periods and must be renewed accordingly.
Additional Costs: There may also be extra costs for document preparation (translations, notarization) or, in some cases, clinical trials, especially for higher-risk devices.
How OMC Medical Can Assist You
At OMC Medical, we understand the complexities involved in the CDSCO registration and import license processes. Our experienced team helps manufacturers by guiding them through the entire procedure, making sure everything is in order.
Here’s how we can assist you:
Clarifying Fee Structures: We’ll help you understand the exact registration and import license fees for your device, so you can plan your budget without surprises.
Document Preparation: We assist in preparing all necessary documents, including the Device Master File, ISO 13485 certification, and others required for the application.
SUGAM Portal Support: Our team will take care of submitting your application online, ensuring all forms are filled out correctly and on time.
Post-Market Compliance: Once your product is registered, we’ll support you with post-market surveillance and ensure your product stays in compliance with ongoing regulatory requirements.
Conclusion
Understanding the CDSCO registration and import license fees is a crucial part of entering the Indian market. By planning for these costs and working with an experienced team like OMC Medical, you can ensure a smoother path to market entry. Whether you’re registering a low-risk or high-risk device, we’re here to guide you through the entire process.
