South Korea - Amendments to the “Enforcement Rule of the Medical Devices Act”

1. The Medical Devices Act was revised and promulgated on July 20, 2021, to mandate the sealing of medical devices that may be contaminated from an opened or compromised package and to ban the sale of medical devices that are packaged in opened or unsealed containers. Accordingly, the Enforcement Regulations of the Medical Devices Act are to be revised to define the medical devices that shall be subject to package sealing as well as the sealing requirements.

 

2. The Medical Devices Act was revised and promulgated on August 17, 2021, to replace the Re-examination system (for newly developed medical devices, etc) with the Post-Market Surveillance system (for newly developed medical devices, etc). Accordingly, the Enforcement Regulations of the Medical Devices Act are to be revised to provide operational guidance and to define the medical devices that are exempt from post-market surveillance.

 

Proposed date of adoption: to be determined

Proposed date of entry into force: to be determined

Final date for comments: November 23, 2021