MFDS

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.

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.

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.

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.

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.

South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.

Key Changes to South Korean Medical Device, IVD Regulations Set for 2015

South Korean medical device regulators will implement significant changes affecting compliance requirements for medical device and in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.

South Korean Medical Device Regulators Ban Some Raw Materials

South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production.

Expedited COFEPRIS Registration Planned for South Korean Medical Devices

Medical devices registered for sale in South Korea are expected to soon have expedited access to the Mexican market.

Korean Regulators Waive Registration Requirements for Some Mobile Medical Devices

The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products—including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.

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