Biological Effect

Biological safety Medical Devices in Korea

Minor change, South Korea

Limited Revision Notice regarding Biological Safety of Medical Devices published by South Korea MFDS Reasons for Revision (biological safety medical devices) The international requirements regarding the biological safety for medical devices that are internationally accepted has been partially changed subsequent to the revision of International Standards for medical devices (ISO 10993-4, 9, 10, 13, 16).…

pacemaker

South Korea MFDS notice

Country registration, major change, South Korea

Here is the Ministry of Food and Drug Safety Notice No. 2014-87 from South Korea. South Korea MFDS is  revising 「Regulations regarding Medical Device Products and Product Classification」 (Ministry of Food and Drug Safety Notice No. 2014-88, 2/12/2014) in part, and gathering consensus from the people. They are hereby giving a notice regarding the purpose,…