China's current "Medical Devices Supervision and Administration Regulations" stipulates that medical devices are managed in three categories.
The first category refers to the routine management is sufficient to ensure the safety and effectiveness of medical devices. Such as: basic surgical instruments (knife, scissors, pliers, tweezers, etc.), general diagnostic instruments (stethoscope, percussion hammer, reflective instruments, etc.), medical radiation protection and bandages, ointments and so on. Open the first class of medical equipment production, business enterprises in the provincial bureau for the record, do not need to apply for a license. Production of Class I medical devices to be in the local municipal drug supervision department for the production of registration certificates. Class II refers to its safety, effectiveness should be controlled medical devices. Such as: medical electronic equipment (heart, brain diagnostic equipment, non-invasive monitoring equipment, etc.), B-type ultrasound diagnostic equipment, clinical testing and analysis of some of the instruments, as well as thermometers, blood pressure monitors and so on. It should be noted that the state has been part of the second class of medical devices into the business license is not required to deal with products can be operated. Such as: thermometers, sphygmomanometers, medical cotton wool, cotton gauze, sanitary masks, home blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test side test strips), condoms and so on. To open the second class of medical devices production and business enterprises to apply for production and business enterprise license in the provincial bureau, the production of second class medical devices to apply for the production of registration certificate in the provincial bureau. Class III refers to medical devices that are implanted in the human body; used to support and sustain life; potentially dangerous to the human body, for which safety and effectiveness must be strictly controlled. Such as: extracorporeal circulation and blood processing equipment, implantable materials and artificial organs, medical polymer materials and products in the disposable blood transfusion, infusion set, injection puncture device in the disposable syringe, corneal contact lenses and so on. To start the production and operation of Class III medical devices, it is necessary to apply for the production and operation enterprise license in the provincial bureau, and to apply for the production registration certificate in the national bureau for the production of Class III medical devices. China's medical device industry in general and the international advanced level there is a gap of more than 10 years, but with the development of electronic technology, computer technology and biomaterials science and the rise of biomedical engineering disciplines, China's medical device industry has gained the theoretical basis for further development and technical source, which led to the technological progress and innovation of the industry as a whole development, embarked on the road of medical device science and technology industry. 90 years since, a large number of new types of medical device production and operation enterprises to the provincial bureau for the production of business license, the production of class III medical devices to the national bureau for the production of registration certificate. Since the 1990s, a large number of new medical devices have been successfully developed and formed a certain production capacity, not only for clinical medicine to provide favorable support conditions and means, but also produced good economic benefits.