J Pharmacoepidemiol Risk Manage.  2021 Sep;13(2):45-54. 10.56142/2021.13.2.45.

Comparison of Postmarket Surveillance Strategies of Implantable Medical Devices in the United States, European Union, and South Korea

• Cho Yo
• Lee JYe
• Shim DaYo
• Park SJ
• Rhee HE
• Sung HG
• Kim HJ
• Choi NK
• Song HJ
• K im JA
• Park Sm
• Shin JY

• KMID: 2534648
• DOI: http://doi.org/10.56142/2021.13.2.45

Abstract

The biomedical industry is making rapid progresses like never before, and the number of adverse events caused by implantable medical devices is also increasing. As such, there is an ever-growing need for post-market surveillance (PMS) procedures on implantable medical devices which ensure both the efficacy and safety of these devices. PMS systems of South Korea were compared to those of the United States (US) and the European Union (EU) - two regions that hold the largest shares in the medical devices market. Each regulatory authority examined in this paper follows a common structure consisting of regular follow-up and tracking procedures. This paper will focus on identifying similarities and differences between current PMS regulations on implantable medical devices in South Korea, the US, and the EU; through these comparisons, we propose strategies to improve the surveillance system currently available in South Korea.

Keyword

Product surveillance; Patient tracking; Implants; Medical device