New CDx Requirements In Japan

On March 31, the Japanese MHLW issued a notification allowing CDxs to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs that have identical indications. ... Read More


Thailand Medical Device Approval Process Has Been Simplified With The Removal of the Pre-submission Step

In an effort to expedite the device registration process, the Thai FDA has ended the pre-submission stage of the Thai application process. Previously, applicants for Thai device approval had to provide basic information about the product and wait for the TFDA’s response to determine its specific grouping and classification. However, today with the... Read More