South Korea medical device registration update: electrical and mechanical safety

Korean Ministry of Food and Drug Safety (MFDS) recently released a revision of its reference standard as per Ministry of Food and Drug Safety Notice No. 2014-122 affecting South Korea medical device registration. The purpose is to align with international standards related to electrical and mechanical safety. Are covered the following: radiation safety, usability, alarm…

south korea medical device regulations update

A notice is given for Limited Revision regarding Medical Device Act 1081; released May 9, 2014 of the South Korea medical device regulations as below: 1. Reasons for Revision A. Subcontracting B. In-Vitro Diagnostic C.License Modification exemption D.Distribution Quality Management Standard E.Periodic Reporting F. Recall Notification The pharmaceutical drugs and the medical devices are currently…

Biological safety Medical Devices in 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).…

South Korea MFDS notice

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,…

Korean GMP Revision 2 in English

Finally available. Our translation of the Korean GMP Revision 2 in English is ready. The document was validated and is now ready for review. The main modifications are summarized below: Removed GMP inspection for class 1, but tightened for class 2, in the past, for class 2 only document inspection required, but since Jan 2014 it has been changed to site…

Mobile Medical Devices in Korea

In a very similar way as US FDA addressed this topic, South Korean MFDS has announced measures to distinguish mobile medical devices from more fitness related application or devices. The original public consultation is posted here. Comments from the public can be submitted until April 7, 2014. For instance, heart rate monitors and pulse rate…