1. First is a planned revision to the Medical Device Act, and was cited as a matter for medical device companies to prepare in advance.​

For medical devices, if foreign substances were found, the investigation results including the cause and action plans can be announced to public.

(From Feb 17, 2024)

2. The second is the introduction of a medical device CSO (Contract Sales Organization, ‘CSO’) regulation.

The Medical Device Act including this will come into effect on February 9, 2025, but prior preparation is required before that.

The Act defines what to do by CSO and medical device companies and looking at the clauses, applicable companies must prepare in advance before enforcement.