MFDS Says ‘No’ to Full STED Files for Class IV Devices

In a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.

The MFDS notification (in Korean language) come as a great relief for Class IV medical device manufacturers who are in plans of South Korean market-entry. The development is analyzed to be reducing timeframes for submission preparations which in turn may downsize market applicants’ efforts.

However, in place of the full STED files, the Agency directs market applicants to submit some of the STED-related documents inclusive of:

  • Flow charts that depict each step of the entire device manufacturing process
  • Description of different processes that could affect the performance or effectiveness of the device
  • Details and indication of all sterilization methods, standards, validation cycles, and conditions used in the device’s manufacturing process

The new announcement might be a quick relief for applicants. But gaining right knowledge about regional regulations is a key for compliance. Either if you would like to import a device from overseas or if you would intend to produce it within Korea, you would require import business license or manufacturing business license from the MFDS. In such scenarios, it is significant to opt for Regulatory expertise for a compliant market entry. Be informed.