What are the categories of medical devices according to the level of risk?
1. is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on.
2. Is a moderate risk, need to strictly control the management to ensure its safety, effective medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
3. Is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters and so on.
Legal basis:
Criminal Law of the People's Republic of China
Article 114 The direct object of infringement of the crime of placing hazardous substances is the state's prohibited management order on the placing of substances of poisonous, radioactive, and infectious pathogens as well as the public's personal safety and the safety of public and private property. The perpetrator of this crime must have committed the act of endangering the safety of the public by releasing poisonous, radioactive or infectious disease agents, which has not yet resulted in serious consequences; or the act of releasing poisonous, radioactive or infectious disease agents, which has caused serious injuries or death, or which has resulted in significant damage to public or private property. The direct consequence of drug cases is the injury or death of the victim, which directly affects the family.