What are the x-series monitor of medical devices? How is it classified? Currently, many people think that medical devices simply refer to the equipment used in some major surgeries, but this is actually only one of the categories. Common bandages, gauze and even hemostatic patches are all medical devices. I believe we all have a feeling that nowadays, when we go to hospitals or other examination institutions, there are not only simple equipment examination in the past, but also many advanced instruments, and the variety of instruments is very diverse, which shows that with the progress of science and technology, there are more and more types of medical devices and the medical level is improving. In order to better protect the people’s medical safety, the U.S. Food and Drug Administration has classified medical devices.
“Medical Devices for Supervision and Management of Enterprises Regulations” (Order of the State Council of the People’s Republic of China No. 650) Chapter 8 Bylaws of medical devices are defined as instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, material development and some other similar issues or items without related, including the required computer system software, which directly affect or through indirect use in the human body.
The purpose of the use of medical devices.
1. prevention, diagnosis, treatment, monitoring and mitigation of disease
2. diagnosis, treatment, monitoring, mitigation and compensation for injury or disability
3. To study, substitute, regulate, or support anatomical or physiological processes.
4. Support or maintenance of life.
5. Pregnancy control.
6. To provide relevant information for the development of medical or diagnostic purposes by analyzing and examining data from human samples.
What are the criteria and methods of classification of medical devices?
In China, medical devices are classified according to the safety of their products.
1. The first category is low-risk medical devices, whose safety and effectiveness can be ensured through daily management. For example: surgical instruments (knives, scissors, pliers, forceps, hooks), scrapers, medical x-ray films, surgical clothing, surgical caps, examination gloves, gauze, bandages, drainage bags, etc.
2. The second category is a medium-risk medical devices, which require strict control and management to ensure their safety and effectiveness. Such as medical suture needles, sphygmomanometers, thermometers, electrocardiogram machines, electroencephalography machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic sterilization equipment, absorbable sutures, etc.
3. The third category is a relatively high market risk, we need to take some special measures to take strict control of enterprise management to ensure that its information security, effective medical services devices. Such as: implantable pacemakers, corneal contact lenses, IOLs, ultrasound therapy tumor research focus knife, hemodialysis devices, implantable equipment, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters, etc..
At present, China’s medical device companies have gained a large market share in the first and second category markets. For the third category of medical devices, foreign medical devices are the mainstream. Conner has achieved relatively good results in the production of Class I and Class II medical devices. In the future, Conner will continue to take science and technology innovation as an important strategy for enterprise development, continuously increase investment in research and development, consolidate the manufacturing industry, do a good job of expanding the real economy and realize the strategic transformation and upgrading of the enterprise.