Korea Introduces New Medical Device Requirements

At the end of June, Korea’s Ministry of Food and Drug Safety (MFDS) announced three major changes to the country’s Medical Device Act.

The first requires that all Class IV medical devices undergo registration using the Summary Technical Document (STED) format starting January 1, 2014. Korea currently has its own documentation standards, which will not change for Class I, Class II and Class III medical devices. However, manufacturers of these devices will be permitted to use the STED, if they so choose. According to the MFDS, the review timeline for all STED applications will be expedited.

The second change deals with the safety and performance standards for electrical equipment in medical devices. Previously, Korea regulated electrical safety tests according to the second edition of IEC 60601-1, which was released in 1988. Starting June 1, 2014, all Class III and Class IV medical devices will be evaluated according to the third edition of IEC 60601-1. Class II medical devices must be compliant by June 1, 2015, and Class I medical devices must be compliant by June 1, 2016.

The third major change deals with the re-classification of several medical device products. Updates are effective immediately and include:

  • The addition of 94 new products to the “cell manipulating kit for medical use” class
  • New definitions for 108 products including “heater system”
  • The downgrading of “dental color measuring devices” from Class II to Class I
  • The deletion of 67 commercial names including “warm bath equipment.”

These changes are consistent with the MFDS goals of minimizing information submission, speeding up registration timelines and improving the predictability of information requirements. Like other countries in Asia (Taiwan and the ASEAN nations, for example), Korea is also moving to join Australia, Canada, the EU, Japan and the US in the use of the STED submission format.