Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.

The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. The CFDA is separated into various departments that are individually responsible for the registration, tracking, and mon

Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of the State Council on October 1, 2017, the fo

BEIJING - China reported 41,018 medical device adverse events (MDAE) in 2014, up 18.6 percent from the previous year, according to China Food and Drug Administration (CFDA) Monday.

In China, Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents are regulated by following laws: The Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)-main regulation Administrative Measures for Medical Device Registration(CFDA Order No. 4 2014) Adm