,Navigating Korea's MedTech Market: Regulatory Strategy & Pathways to Success
Topics Covered:
In a nutshell, during the webinar, our presenters – Stephen Jeong discussed the following topics:
- Freyr Overview
- South Korea MedTech Market Overview
- Strategy Advantages for Chinese Companies
- South Korea’s medical device Classification and Regulatory requirements
- KGMP & its Importance
- South Korea’s Regulatory pathway and necessary certifications
- Practical Regulatory strategy to enter South Korea Market
- Success Story
- Freyr’s advantages for Chinese manufacturers to enter the South Korean Medtech industry
- Live Q&A
As a continuous practice, Freyr organizes more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If yes, let us have an opportunity to inform you about our next session.
Mandy Zhao is the Head of Business Growth for Greater China at Freyr, where she leverages over 10+ years of experience in the life sciences industry. With a deep understanding of global Regulatory frameworks and market access strategies, Mandy has played a pivotal role in supporting Chinese medical device manufacturers through successful expansions into international markets. At Freyr, she has been instrumental in fostering strong partnerships and delivering customized solutions to address the unique challenges faced by companies entering highly regulated regions
Stephen Jeong is a Senior Manager and Country Delivery Manager at Freyr Solutions, specializing in regulatory affairs and quality assurance for the medical device industry. In his role, he leads consulting projects and provides expert guidance to clients on regulatory strategy and compliance to transform their innovative ideas into safe and effective products.
With a comprehensive understanding of complex international regulatory environments, including standards like ISO 13485, Stephen supports every stage of medical device development and approval. Prior to his current role, he gained extensive experience at multinational company, managing regulatory affairs for a portfolio of medical devices and leading Korea Good Manufacturing Practices (KGMP) certifications. His background also includes roles as an RA&QA Consultant and a Sales representative.
Stephen holds a Bachelor of Engineering in Biomedical Engineering. He is a certified Medical Device RA Professional and a CQI and IRCA certified Lead Auditor for Medical Devices Quality Management Systems.
Host
Mandy Zhao
Associate Director for Business Growth in China, Medical Devices
Presenter
Stephen Jeong
Stephen Jeong is a Senior Manager and Country Delivery Manager at Freyr Solutions