Although China’s medical regulatory bodies are coordinating more and more with international standards, the Chinese medical device approval process still poses significant difficulties for Western medical technology companies.
The China Food & Drug Administration (CFDA) is responsible for regulating medical devices, drugs, and healthcare services in China. The organization is headquartered in Beijing, with offices in each province.
Pharmaceutical and medical device manufacturers intending to market products in the Chinese market – one of the most rapidly growing in Asia – will need to obtain regulatory approvals from the CFDA according to the Chinese regulations, and re-certify once every 5 years.
