Medical Device Import License Consultant in Delhi NCR: CDSCO MD 15 License
Looking for a Medical Device Import License Consultant in Delhi NCR? MedDev Experts can help you obtain your MD 15 License on time and within budget.
Are you looking to obtain a CDSCO MD 15 License to Import medical devices in India? Get your CDSCO MD-15 License efficiently with MedDev Experts! Our expert team is here to guide you through the process with ease. We have a proven record of accomplishment of 100+ successful medical device import licenses in India. We ensure timely processing and seamless guidance throughout the application process.
Complying with CDSCO’s Medical Device Regulations (2017) is essential for importing medical devices. Our team simplifies obtaining your CDSCO Import License to meet all regulatory requirements for distribution and sale in India.
Leverage our expertise to navigate the complexities of medical device import regulations. We’ll ensure your application meets all CDSCO requirements for a smooth and successful process.
Understanding India's Medical Device Import License Regulations
Obtaining a CDSCO MD-15 License is crucial for navigating India’s medical device import landscape. Here’s a breakdown of the key regulations:
Classification System:
Medical devices are categorized based on risk – Class A (low risk) to Class D (high risk). The classification determines the level of regulatory scrutiny for your import license application.
Registration Requirements:
All Class A (Measuring/Sterile), B, C, and D devices require MD 15 License from the CDSCO. Class A (Non-Measuring/Sterile) devices require online registration, while others involve a more detailed process.
Import License:
An MD-14 application initiates the import license process. This requires a comprehensive Device Master File (DMF) detailing your product and a Plant Master File (PMF) for the manufacturing facility. Upon approval, the CDSCO issues an MD-15 Import License to a local license holder representing the manufacturer.
Compliance with Standards:
Your devices must comply with the latest BIS standards, often harmonized with international standards like ISO. The CDSCO may require additional testing or conformity assessment depending on the device class.
Post-Market Surveillance:
License holders have a responsibility for post-market surveillance to ensure device safety and effectiveness. This may involve reporting adverse events and implementing corrective actions when necessary.
Staying Updated:
The Indian medical device regulatory framework is evolving. Consulting with experienced professionals like MedDev Experts can help you stay informed about the latest regulations and ensure a smooth import process.
In conclusion, navigating India’s medical device import regulations can seem complex, but with the right partner, it doesn’t have to be.
MedDev Experts’ team of consultants possesses the experience and knowledge to simplify the process, ensuring a timely and successful CDSCO MD 15 License acquisition.
Contact us today to discuss your specific needs and get started on bringing your medical devices to the Indian market with confidence.
