Medical Device Registration in South Korea - Biologics Consulting Group

MISSION-DRIVEN

Medical Device Registration

The process of selecting business partners and concluding contracts is one of the crucial decisions that can determine the success or failure of a company. BCG recognizes this importance and provides due diligence services to identify the strengths, weaknesses, or risks of partners in advance, and supports the entire partner selection process, including contract review.

Moreover, BCG provides gap analysis services to thoroughly understand customer requirements and assist in achieving the best results in collaboration with partners. This ensures efficient cooperation with clients, minimizing resources and time invested in projects, and more reliably supporting the achievement of project goals.

Home » Services » Medical Device Registration

Import/Manufacturing License

BCG provides services for obtaining medical device import and manufacturing licenses in South Korea. The regulatory and licensing process for medical devices can vary by country, and we possess expertise in South Korean regulatory and licensing requirements.

Our services provide necessary support for companies looking to start or expand medical device businesses in South Korea. This includes regulatory compliance, documentation preparation and submission, and all steps required for entering the domestic market. BCG's medical device licensing services provide all the knowledge and tools needed for medical device business in South Korea, helping clients efficiently obtain licenses and successfully operate their business.

Licensing and Technical Documentation

BCG provides medical device licensing consulting services in various countries and regions, including South Korea, the U.S. 510(k), Europe CE MDD/MDR, IVDD/IVDR. BCG's consultants, with extensive experience in each country and region, support clients in all steps from the creation, review, submission, and supplementing of technical documentation for product licensing. BCG's goal is to help clients smoothly obtain medical device licenses, fully comply with regulatory requirements, and successfully compete in international markets.

GMP / QMS

BCG's GMP (Good Manufacturing Practice) and QMS (Quality Management System) consulting services ensure regulatory compliance in various countries and regions, including South Korea's KGMP, the U.S. FDA QSR, and ISO 13485.

Our services provide the following key functions:
- QMS Initial Setup: BCG assists clients in effectively establishing quality management systems, enhancing product quality and regulatory compliance.
- QMS Enhancement: With the introduction of new regulations like ISO 13485:2016 and FDA QSR, BCG suggests necessary actions to clients and performs supplementary work to ensure regulatory compliance.
- Inspection/Due Diligence Preparation: BCG supports document preparation and process improvement in preparation for regulatory audits, preventing inaccurate results during audits and ensuring readiness.
- Response to Audit Findings: BCG develops and implements strategies to address findings from audits. This ensures smooth cooperation with regulatory agencies and maintains compliance.
- BCG's GMP and QMS consulting services support clients in ensuring the quality and regulatory compliance of their products, facilitating success in international markets.

PATH TO SUCCCESS

Contact Us

Needing an expert? Please feel free to contact us anytime.