South Korea Blog Posts

In Brief: South Korean Medical Device Information & Technology Assistance Center Changes Name

EMERGO SUMMARY OF KEY POINTS:

  • The South Korean Medical Device Information & Technology Assistance Center (MDITAC) is changing its name to the National Institute of Medical Device Safety Information (NIDS).
  • Functions and responsibilities of the division remain the same.
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South Korean MFDS Revises Recently Enacted Medical Device Regulations

EMERGO SUMMARY OF KEY POINTS:

  • The South Korean MFDS has updated medical device regulations covering premarket reviews, registrations and enforcement.
  • MFDS is also seeking industry comment on a draft proposal updating medical device safety and adverse event reporting requirements.
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South Korean MFDS Launches Recall System for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • A new medical device recall system in South Korea blocks sales of certain devices to consumers if safety issues arise.
  • The MFDS Harmful Medical Device Distribution Shutdown System went into effect in March 2017.
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South Korean Regulators Clarify Medical Device UDI, KGMP Rules

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s MFDS has clarified new and upcoming requirements regarding unique device identification (UDI), KGMP quality system audits and medical device expenditure reports.
  • UDI requirements will come into force on a rolling basis through 2022.
  • Various KGMP audit requirements have been streamlined or eliminated for some device classes.
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Updates on South Korean Medical Device Regulatory Changes

EMERGO SUMMARY OF KEY POINTS:

  • Several South Korean medical device and IVD regulatory changes have taken effect in late December 2016 and early January 2017.
  • These regulatory changes affect issues including IVD documentation requirements, medical device advertisements and MDITAC review processes.
  • Premarket review fee increases have not yet been finalized by the Ministry of Food and Drug Safety, but are expected to take effect in 2017.
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South Korean MFDS Updates on Transition to IEC 60601-1 (Ed. 3.1)

The South Korean Ministry of Food and Drug Safety (MFDS) recognizes IEC 60601-1 (Ed. 3.1).  Now that IEC 60601-1 (Ed. 3.1) had been amended, the MFDS amended the “Common Specification for Electrical Safety of Medical Device” for international harmonization of standards.

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Analysis of New Draft Regulation for Medical Devices in South Korea

Emergo consultants in Seoul have conducted a thorough analysis of draft Ministry for Food and Drug Safety (MFDS) revisions to South Korean medical device and IVD regulations announced earlier in 2015 to highlight major changes between current and proposed new requirements.

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