Medical Device Market Access Consulting Services

MISSION-DRIVEN

Product Registration

BCG specializes in providing essential support for the product approval process of medical devices and in-vitro diagnostic devices, helping them enter both domestic and international markets. We systematically manage the entire process, including the preparation of technical documentation, submission, and response to audits, tailored to the regulatory requirements for each classification (Class 1, 2, 3, 4). This enables clients to proceed with the approval process quickly and efficiently.

Based on a deep understanding of medical device regulations and the latest regulatory trends, we provide customized solutions to ensure that our clients' products demonstrate safety and efficacy while meeting regulatory requirements. Simplify the complex product approval process with BCG and gain a competitive edge in the market.

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Medical Device Classification/Product Inquiry

We provide clear guidance on whether the product you wish to register qualifies as a medical device under domestic regulations and, if so, how it is classified. Through inquiries with the Ministry of Food and Drug Safety (MFDS), we provide precise answers to prevent confusion during the product registration process.

Approval and Technical Documentation Preparation

BCG provides consulting services for the approval of Class 1, 2, 3, and 4 medical devices and in-vitro diagnostic devices. With extensive experience in South Korea's regulatory requirements, BCG consultants expertly support the entire process, including technical document preparation, review, submission, and amendments.

BCG's goal is to help clients quickly and smoothly obtain medical device approval in South Korea while fully meeting regulatory requirements to successfully enter the market.

Product Testing

BCG works with reliable testing organizations to conduct essential international standard tests (such as IEC 60601, ISO 10993) required in the medical device approval process. We support all stages, from selecting testing organizations, developing test plans, managing the process, reviewing results, and preparing reports, in close collaboration with the client.

BCG consultants leverage their extensive experience with test requirements and regulatory standards to prevent potential issues during testing and help clients obtain the necessary data accurately. If the test results do not meet regulatory requirements, we quickly provide corrective strategies.

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