Hello~ 1. Does anybody know how to obtain GMDN Codes for free? 2. What does "Device Packaged as Sterile" mean? Our glucose kit contains a meter,...
So, if foreign regulatory bodies such as the FDA are still going to be conducting their own quality audits (independent of MDSAP), what's the...
Believe it's minimum of two CFDA approved centers. Need IRB approval before starting the trials and the cost needs to be worked out between you...
The registration costs for domestic products will be determined by local FDAs. So far only one state has published it and others may follow...
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