Disposable syringes belong to Class III medical devices - 6815 injection and puncture devices; disposable infusion sets belong to Class III medical devices - 6866 medical polymer materials and products. Both of them are accepted by the Registration Division II of the Department of Medical Devices of the State Food and Drug Administration (SFDA).
Class III medical devices used for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring system, IOLs, invasive endoscopy, ultrasound scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, X-ray therapeutic equipment, X-ray machines over 200mA, CT equipment, etc..
Expanded Information:
Medical Devices Regulatory Department of the Department of Medical Devices. p>Medical device regulatory department under the State Food and Drug Administration, its main responsibilities are: organization of the formulation of national medical device standards and supervise the implementation of the formulation of medical device classification and management directory; undertake the registration and supervision and management of medical devices; the formulation of clinical trials of medical devices, production, management and supervision of the implementation of quality management standards; the formulation of the medical device production and management of business access conditions and supervise the implementation of the; Undertake medical device clinical trial organization accreditation work.
Responsible for the organization and management of medical device registration on-site verification work; undertake medical device testing organizations accreditation and supervision and management; undertake the supervision of medical device production and operation licensing; undertake the supervision of the export of designated medical device products; organization of the monitoring of adverse events of medical devices, re-evaluation and elimination of the work; undertake the Bureau of other matters assigned.
Baidu Encyclopedia - Class III Medical Devices
Baidu Encyclopedia - Medical Devices Supervision Division
People's Daily Online - Disposable Syringes and Infusion Devices Included in the Strongest Supervision