Having visitors is not always a pleasure. On top of that some of them have the right to step in. So it’s better to be prepared for that situation and deal with it no matter what happens. How do you deal with Notified Body Unannounced Audits announced to be taking place soon (if not already)…
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change ? Since it is very hard to figure out just by reading the publication on the Official Journal of…
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).…
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,…
As per Notice from MFDS: The Heart Rate Monitor and Pulse Monitor that are used for exercise and leisure purpose need not be included in the product classification for the medical purpose. In defining the Heart Rate Monitor and Pulse Monitor, those that are designed for exercise and leisure will be excluded (Appendix A26080.01, A26080.02).…