Problem Statement:
A healthcare company specializing in innovative medical devices sought to import its Urethra Catheter, designed to minimize iatrogenic urethral injuries, into India. To meet Indian regulatory requirements, the company needed to obtain a CDSCO import license under Form MD-15, as mandated by the Medical Device Rules, 2017, for safe and compliant market entry.
Our Solution:
- Classification and Compliance:
D2R identified the appropriate device classification under CDSCO regulations and outlined the necessary documentation and compliance steps for the catheter’s importation. - Documentation Preparation:
D2R prepared a detailed submission, including:- Device Master File (DMF) with comprehensive specifications.
- Free Sale Certificate (FSC) from the manufacturing country.
- Regulatory certifications and details of the manufacturing facility.
- Post-market surveillance and vigilance plans to ensure safety monitoring.
- Form MD-15 Submission:
The Form MD-15 application was compiled and submitted with precision, incorporating all required technical, clinical, and regulatory data to ensure compliance with CDSCO standards. - Regulatory Coordination:
D2R worked closely with CDSCO officials during the review process, promptly addressing any queries to facilitate a smooth and timely approval.
Outcome:
The client successfully obtained the CDSCO import license, enabling the Urethra Catheter to enter the Indian market. The device is now positioned to improve patient outcomes through safer catheterization practices. With D2R’s expertise, the licensing process was completed efficiently, ensuring full compliance with Indian regulations.
