CFDA GMP and Manufacturing License
When you plan to manufacture your device in China, your facility needs to meet the CFDA manufacture quality management requirement (like GMP or ISO 13485). Even if your device to be submitted to CFDA is manufactured outside of China, the GMP audit may also be required by CFDA.

BioHan Consulting provides the training on CFDA GMP requirement, helps to get the manufacturer’s license from CFDA, as well as supports to pass the CFDA GMP audit in China or outside of China if required.