
Hoon Lee
AdvisorIntroduction
After graduating from Chung-Ang University Physics Department, Mr. Hoon Lee worked for various divisions and departments at the Ministry of Food and Drug Safety, including Medical Device Policy Division, Medical Device Quality Division, Criminal Investigation Division, Cyber Investigation Division, Innovative and Diagnostic Medical Devices Policy Division, for about 15 years, developing policies, licensing, GMP and follow-up management in the field of healthcare. In particular, Mr. Lee had experience in handling numerous policies and incidents while serving in the medical device field.
Since his joining Shin & Kim’s Pharmaceutical, Medical, Bio and Healthcare Team in 2022, Mr. Lee has provided practical advice on the application and interpretation of the Medical Devices Act, the Act on In Vitro Diagnostic Medical Devices, and other applicable laws and regulations related to food and medicine.
Areas of Expertise
Professional Career
- 2022-PresentShin & Kim LLC
- 2011-2022Innovative and Diagnostic Medical Devices Policy Division, Ministry of Food and Drug Safety
- 2019-2021Medical Device Safety Management TFT Head, Gyeongin Region Ministry of Food and Drug Safety
- 2018-2019Cyber Investigation Division, Ministry of Food and Drug Safety
- 2015-2018Medical Devices Policy Division, Ministry of Food and Drug Safety
- 2012-2015Criminal Investigation Division, Ministry of Food and Drug Safety
- 2006-2012Medical Device Quality Division, Ministry of Food and Drug Safety
- 2001-2005Research Fellow, Solco Biomedical Co., Ltd.
Education
- 2001Chung-Ang University, Graduate School of Physics (M.S.)
- 1999Chung-Ang University, Physics Department (B.S.)
Languages
Korean, English
Media
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Newsletters Overview and Outlook on the Recently Implemented Medical Device Liability Insurance System
2022.09.30