Republic of Korea - Amendment of Regulation on standard specification of medical devices :

Ministry of Food and Drug Safety has issued notification amending regulation on standard specification of medical devices. This amendments covers following changes;

• Harmonized standard specification of medical device with IEC (International Electro‑technical Commission), ISO (International Organization for Standardization) international standard
• Objects of enactment and revision are total 49 standard specifications
• Medical devices that are powered by electricity: 10 standards' enactments, 23 standards' revisions
• Medical devices, for example, medical supplies, dental materials, that are not powered by electricity: 8 standards' enactments, 8 standards' revisions
• In case of medical electrical devices, standard specification is to be harmonized with IEC 60601 3ed. particular standards

Final date for comments: 60 days from date of notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.