US-S. Korea Trade Pact Promises Transparency for Devicemakers

A recent U.S.-South Korea free trade agreement is believed to be the first between the U.S. and another country to contain a section specifically for medical devices. The agreement promises more regulatory transparency from S. Korea, whose government must propose regulations in a single official journal of national circulation as well as other channels. Devicemakers will get the chance to comment, in most cases within 60 days, on regulations. All formal requests to the S. Korean government for the pricing or approval of devices for repayment should be completed within a reasonable, specified period disclosed to the applicant.
International Medical Device Regulatory Monitor