From Jan 01 2023, the overseas manufacturer on-site inspection of medical device has been effective.

For details, please contact me(chk3424@naver.com) or your agency in Korea because the details might be changed under certain external evironment.

Overview

To prevent COVID-19 prevention and expansion, document review etc. is done (‘20.2~’22.12) on the overseas manufacturer on-site inspection.

* Medical device GMP audit plan related to new COVID VIRUS infection (’20.12)

코로나 19 예방 및 확산방지를 위해 해외 제조소 현장조사를 서류 검토 등으로 대체(‘20.2~’22.12)하여 운영 중

* 신종 코로나바이러스 감영증 발생관련 의료기기 GMP 심사방안 알림(‘20.2.12)

코로나 19로 인한 각국 입국 관련 조치사항이 완화됨에 따라 해외 제조소 현장조사 세부운영 계획 마련 필요

Because each country entry actions are eased, overseas manufacturer on-site inspection detailed operation plan is required.

해외제조소 현장조사 재개방안

Restart plan on overseas manufacturer on-site inspection