China CFDA regulations in English Version
Read the most update-to-date regulatory information for medical industry!
15 Jun
All the medical devices require local testing in China for CFDA registration, which is generally done in a CFDA-accredited lab. Recently, the Ministry of Finance of China has released a notice to eliminate several items of fees charged by the authorities (Finance Tax [2017] No. 20), including the certification fees for drug good manufacturing practice […]
14 Jun
The China Food and Drug Administration (CFDA) has been using the four-digits category system for medical device since the year of 2000. Currently, all medical devices are divided into 43 categories from “6801” to “68xx”. The category information is embedded in the CFDA certification number as the second and third digits. For example, a certificate of […]
19 May
The only medical device law “Regulations for the Supervision and Administration of Medical Devices” is updated again on May 19th,2017 and signed by the premier LI Keqiang as State Council Decree No. 680. The last version, State Council Decree No. 650 was issued and became effective just two years ago.
