韓國技術性法規通知文件(TBT通知文件)

發出會員國: 韓國KOR
文件編號: G/TBT/N/KOR/1001
標題: Committee on Technical Barriers to Trade - Notification - Republic of Korea - Medical devices
文件通知日期: 2021/10/22
評論截止日期: 2021/12/21
產品內容: 【中文】

韓國 通知-醫療器材

【原文】

Medical Devices

產品內容說明: 【中文】

韓國食品和藥品安全部(MFDS)正在修訂《醫療器材法實施細則》,具體內容如下:

1.《醫療器材法》已於2021年7月20日修訂並頒佈,以強制要求密封可能被打開或損壞的包裝所污染的醫療器材,並禁止銷售被打開或未密封容器包裝的醫療器械。因此,將對《醫療器材法實施細則》進行修訂,以界定應進行包裝密封的醫療器材,以及密封要求。

2.《醫療器材法》已於2021年8月17日修訂並頒佈,以後市場監督制度(針對新開發的醫療器材等)取代重新審查制度(針對新開發的醫療器材等)。因此,《醫療器材法實施細則》將被修訂,以提供操作指南,並界定免於上市後監督的醫療器材。

【原文】

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the "Enforcement Regulations of Medical Devices Act" as stated below:

  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.
G/TBT/N/KOR/1001 的所有原始文件:
序號文件編號文件標題通知日期下載文件(另開視窗)
1 G/TBT/N/KOR/1001 Committee on Technical Barriers to Trade - Notification - Republic of Korea - Medical devices 2021/10/22下載文件