The State Food and Drug Administration recently released the "supervision and management of the sale of medical devices network approach", which stipulates that enterprises engaged in the sale of medical devices network offline should have the qualification of medical equipment production and operation. The Measures will come into force on March 1 this year.
According to the State Food and Drug Administration of the relevant departments and bureaus responsible for the introduction of the approach to adhere to the principle of online and offline consistency, clearly engaged in the network sales of medical devices production and operation of enterprises and listed license holders, the conditions of sale should be consistent with the "Supervision and Administration of Medical Devices Regulations" and the requirements of the approach; network trading services, third-party platform providers should be audited to confirm that the platform of the enterprise's medical device production and operation qualifications. The third-party platform provider of network trading services shall examine and confirm the medical device production and operation qualification of enterprises on its platform.
Medical devices refer to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.