Jul 27, 2022

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.

The announcements include:

  • Where COVID-19 self-test kits may be sold to be exempt from sales reporting.
  • How implantable medical device manufacturers must comply with patient compensation insurance requirements. Answers to common questions are in a new FAQ document.
  • Which institutions have been designated for non-clinical testing of medical devices.

All links below are in Korean.

Multiple MFDS notices released

First, the MFDS released Notice No. 2022-330 regarding where COVID-19 self-test kits may be sold in order to qualify for temporary exemptions from the medical device sales business reporting requirement. This is in accordance with Article 54 (3) of the Regulations on the Examination of Notification of Authorization of In Vitro Diagnostic Devices (Notice No. 2022-9 of the Ministry of Food and Drug Safety). The notice is valid from July 20, 2022 to September 30, 2022 (subject to change depending upon the results of the implementation).

Second, the MFDS published a notice that outlines the implementation of the medical device insurance system from July 21, 2022. Attached to the notice is a document with answers to frequently asked questions (FAQs) that manufacturers and importers of implantable medical devices may ask regarding the requirement that they purchase insurance to compensate patients for damages suffered due to side effects caused by the devices.

Third, the MFDS issued Notice No. 2022-321, Designation Status of Non-clinical Testing Institutions for Medical Devices. With this notice, the regulator has released its list of institutions designated for the non-clinical testing of medical devices as of July 15, 2022.

Emergo by UL will post updates to these regulations as they become available.

Learn more about complying with South Korean medical device regulations from Emergo by UL:

Author

  • Kathryn Burke's picture
    Kathryn Burke

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