K
kimberley
Hi All,
I was hoping that someone would be able to assist me with this as I seem to have hit a wall!
I am currently trying to determine the classification (and subsequently, the registration requirements for) of IVD medical devices in South Korea.
I have searched (extensively) the KFDA and Emergo sites and cannot seem to ascertain exactly how these devices are classified. I know that IVD regulations in South Korea are changing i.e. IVDs are now being regulated as medical devices in the order of 'high risk' where previously they were regulated as pharmaceuticals. However, I cannot determine if all IVDs are to be considered 'high risk' (class IV) in South Korea, even those which are self-certified in the EU (as per 98/79/EC).
I have emailed the KFDA and have had no respponse.
Any advice would be greatly appreciated!
Thanks so much,
Kimberley
I was hoping that someone would be able to assist me with this as I seem to have hit a wall!
I am currently trying to determine the classification (and subsequently, the registration requirements for) of IVD medical devices in South Korea.
I have searched (extensively) the KFDA and Emergo sites and cannot seem to ascertain exactly how these devices are classified. I know that IVD regulations in South Korea are changing i.e. IVDs are now being regulated as medical devices in the order of 'high risk' where previously they were regulated as pharmaceuticals. However, I cannot determine if all IVDs are to be considered 'high risk' (class IV) in South Korea, even those which are self-certified in the EU (as per 98/79/EC).
I have emailed the KFDA and have had no respponse.
Any advice would be greatly appreciated!
Thanks so much,
Kimberley