"Rapid Response to Adverse Effects of Human Implantable Medical Devices"... Medical Device Act Amendment Passed by National Assembly

Certification of Natural and Organic Cosmetics Shifts to Private Autonomy with Amendment of the Cosmetics Act

The amendment to the 'Medical Device Act,' which enables early detection of adverse cases related to human implantable medical devices, has passed the plenary session of the National Assembly.

On the 31st, the Ministry of Food and Drug Safety announced that the amendment to the Medical Device Act and the amendment to the 'Cosmetics Act' were passed at the plenary session of the National Assembly.

With the amendment to the Medical Device Act, in the case of human implantable medical devices with high concerns about side effects, such as breast implants, information on initial procedures, patient data, and post-implantation side effects can be collected from medical institutions for comprehensive analysis and evaluation. Accordingly, the Ministry of Food and Drug Safety expects to be able to detect adverse cases related to human implantable medical devices early and take prompt action before large-scale side effects occur.

Along with this, the amendment to the Cosmetics Act transitions the existing government-led certification of natural cosmetics and organic cosmetics to a private certification system, allowing for autonomous management. The Ministry of Food and Drug Safety anticipates that the burden on the industry, which had to obtain dual certifications?government certification and internationally recognized private certification for exports?will be reduced.