Oct 9, 2013

The Korean Ministry of Food and Drug Safety (MFDS) has exempted (link in Korean) all Class I low-risk medical devices from quality system requirements previously necessary to obtain market authorization in South Korea.

Prior to September 16, 2013, Class I Special Control device manufacturers were subject to document audits to verify compliance with Korea Good Manufacturing Practice (KGMP) quality management system requirements.

Now, Class I manufacturers and their Korea License Holder authorized representatives may begin marketing their devices in Korea after electronic submission pre-market notifications to the MFDS. One less barrier to market entry for low-risk medical devices will no doubt drive more interest from foreign manufacturers in South Korea.

Stewart Eisenhart

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  • Stewart Eisenhart

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South Korea Regulators Scale Back KGMP Inspection Requirements

The Korean Food and Drug Administration (KFDA), South Korea’s medical device market regulator, has eased some of its Korea Good Manufacturing Practice (KGMP) quality system requirements for medical device manufacturers in order to streamline its inspection process, Emergo Group’s Seoul office has learned.

In some instances going forward, onsite KGMP quality management system audits of foreign manufacturers will be conducted only by third-party inspectors, whereas previously such inspections were carried out by both third-party and KFDA personnel. The revised KFDA regulations will have the following specific effects:

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