China – IVD classification rules, medical device self-testing requirements

The China National Medical Products Administration (NMPA) has published new classification rules for in-vitro diagnostic (IVD) medical devices, as well as requirements for manufacturers to self-test their devices for Chinese market registration.

New IVD classification rules issued

The NMPA’s Classification Rules for In Vitro Diagnostic Reagents (link in Chinese) are based on requirements implemented by the regulator’s predecessor organization, the China Food and Drug Administration (CFDA), and reflect principles for IVD classification developed by the International Medical Device Regulators Forum, or IMDRF…