Client:
The client, a pioneering European company specializing in advanced medical technologies, sought regulatory approval for its innovative Holographic 3D Surgery Assistive Device in the Indian market. The device is already approved by US FDA and is CE marked under EU Medical Device Directives (EU MDD). The EU MDD to EU Medical Device Regulations (EU MDR) transition is in progress. The device is considered as a SaMD as per Indian Medical Device Regulations.
Problem Statement:
With the implementation of the Medical Device Rules, 2017, and the subsequent imperative for the compulsory registration of all medical devices in India, the client encountered the task of navigating through the complex regulatory environment in the India pertaining to medical devices. The client had to ensure compliance to the Indian Medical Device Regulation (IMDR) 2017 and secure essential approvals from the Central Drugs Standard Control Organization (CDSCO), which included appointing an Indian Authorized Representative (IAR).
Artixio Solution:
Artixio, with its expertise in Indian medical device regulations, provided a tailored solution to address client challenges:
Registration Understanding: Artixio conducted an in-depth due diligence, comprehensively understanding the medical device description and its intended use. The crucial aspect of the assessment involved accurately classifying the SaMD, as it could potentially fall into either Class B or C. Another critical element was identifying the appropriate predicate device through a comparison of technology and intended use. These measures were essential to ensure the correct pathway and documentation were followed, facilitating an efficient approval process.
Gap Analysis: Artixio meticulously assessed the available device documents and required data in accordance with CDSCO requirements. A thorough gap analysis was conducted, pinpointing regulatory compliance gaps specific to the Indian market.
Remediation: Artixio provided an extensive remediation plan to ensure CDSCO compliance.
Device Master File Preparation: Artixio assisted the client in preparing a comprehensive regulatory Device Master File (DMF) adhering to CDSCO requirements.
Appointing Indian Authorized Representative: Selected as a dependable Indian Authorized Representative (IAR), Artixio supported the client with all necessary documentation for the appointment, ensuring compliance with local regulations.
Submission Process: Artixio created a SUGAM Account on behalf of the client and accurately and promptly submitted Form MD-14 for the application of an import license for the medical device, along with all required documentation and information.
Through collaborative efforts between client and Artixio, the Holographic 3D Surgery Assistive Device obtained successful registration in India. The regulatory process was efficiently navigated, and the appointment of an Indian Authorized Representative strengthened client's position in the Indian market.
Highlights:
Regulatory Compliance: Artixio's meticulous gap analysis and Device Master File (DMF) preparation ensured that client's device adhered to all regulatory standards in India.
Efficient Submission Process: The streamlined submission process, guided by Artixio, facilitated a swift and accurate submission of documents to regulatory authorities.
IAR Appointment: Artixio's is a reliable Indian Authorized Representative and choosing Artixio has enhanced client's regulatory compliance and communication with local authorities.
This case study exemplifies Artixio's commitment to supporting global companies like client in navigating complex regulatory processes, ensuring successful product registrations, and facilitating market entry in India.
For inquiries on regulatory support and global market entry solutions, contact Artixio at info@artixio.com.
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