State Food and Drug Administration Medical Devices Division's main responsibilities are: drafting of relevant national standards, the development and revision of medical devices, sanitary materials, products, industry standards, production quality management standards and supervise the implementation of the State Council's health administrative department to develop medical device product classification and management directory; responsible for the registration of medical devices and supervision and management of medical device products; responsible for the management of medical device manufacturer licensing; It is responsible for monitoring and re-evaluation of medical device adverse events; recognizing the qualification of medical device clinical trial bases, testing organizations, and quality management standard evaluation organizations; responsible for the management of medical device evaluation expert database; responsible for verifying and proposing opinions on medical device registration and quality related issues; undertaking other matters assigned by the Bureau.
The discovery of substandard products should be immediately stopped, reported to the supervision and management department under its supervision to be dealt with (including supervision and destruction): if the packaging labeling, labeling unqualified issues can be in accordance with the National Bureau of Medical Devices "on the medical device specification labeling and packaging labeling of the relevant issues related to the approval of the reply" The relevant provisions of the treatment