Changes in the Southkorean Medical Device Act

Usabilityilty becomes a requirement in Korea


The Southkorean Ministry of Food and Drug Safety (MFDS; former KFDA) implemented several changes of the Korean Medical Devices Act. Some of these changes take effect immediately; others will take effect starting from January 2014. All of these changes affect the approval procedure for new medical products.

Subsequent to the requirement that the technical documentation for class IV products shall be maintained in the STED format, the safety standards for electrical medical products following the IEC60601-1, 3rd edition are required for all electrical medical products. Products classified as class IV and III need to fulfill this standard from June 2014, class II from June 2015 and class I products from June 2016.

With this change in the Medical Device Act the usability of medical products becomes a requirement for the approval process in South Korea. The 3rd Edition of the IEC 60601-1 incorporates, under part 60601-1-6, the established “usability standard” IEC 62366. This means that all manufacturers who want to sell their products on the Korean market need establish the usability engineering process according to the IEC62366 and document this process within the usability engineering file which will become part of the technical documentation.

If you have any further questions regarding the approval process in Korea or other questions regarding the worldwide approval process for medical products, feel free to contact Mr. Thore Reitz.

Announcement of the MFDS: