On December 2, 2016, the anticipated amendments to the
Pharmaceutical Affairs Act and Medical Device Act of Korea came
into effect and similar amendments to the Medical Affairs Act,
which were passed by the Korean National Assembly on December 1,
2016, are expected to come into effect in the end of 2016 or early
2017. The following is a brief summary of the key amendments.
1. Amendments to the Pharmaceutical Affairs Act and Medical
Device Act
A. Heightened Criminal Punishment
The amended Pharmaceutical Affairs Act and Medical Device Act
impose heightened criminal punishment against pharmaceutical
companies, medical device companies, distributors, wholesalers, and
medical professionals1 that give or receive illegal
economic benefits or "kickbacks" for the purpose of
promoting sales of their pharmaceutical products or medical
devices. Under the amendments, such a violation now carries a
criminal fine not to exceed KRW30 million or imprisonment of up to
three
