A
Adele
Hi All,
We are currently going through re-registeration of a medcial device in China and have been asked to provide biocompatibility data.
No problem (or so we thought) and we supplied the biocompatibility test reports that have been used in a number of registerations around the world (including the USA).
However, the testing was done in 2000 and 2001 and the Chinese authorities haven't accepted this as the testing must be to ISO 10993-1: 2003 and the other more recent versions of the specific ISO 10993 standards.
I have tried finding out specifics of the regulation but all I can get is that it is a new regulatory requirement issued in June 2007 (but it isn't available on the English SFDA site).
Does anyone know the specifics of the regulation? Has anyone else come across this problem? How did they solve it?
Thanks!
We are currently going through re-registeration of a medcial device in China and have been asked to provide biocompatibility data.
No problem (or so we thought) and we supplied the biocompatibility test reports that have been used in a number of registerations around the world (including the USA).
However, the testing was done in 2000 and 2001 and the Chinese authorities haven't accepted this as the testing must be to ISO 10993-1: 2003 and the other more recent versions of the specific ISO 10993 standards.
I have tried finding out specifics of the regulation but all I can get is that it is a new regulatory requirement issued in June 2007 (but it isn't available on the English SFDA site).
Does anyone know the specifics of the regulation? Has anyone else come across this problem? How did they solve it?
Thanks!