In recent years, with the increasing awareness of people's health care and the continuous emergence of various new technologies, more and more medical device products have begun to enter the family, and the home medical device market has formed and developed rapidly, becoming a new growth point in the medical device industry.
The definition is yet to be clarified The categories cover a wide range
At present, in the current effective laws and regulations in my country, there is no clear regulation on how to classify household medical devices. The industry generally believes that household medical devices refer to medical devices such as general diagnosis, physical therapy, and hygiene materials that can be judged, purchased and used by consumers. By referring to the "Guidelines for Technical Review of Home In Vitro Diagnostic Medical Device Registration" published on the website of the State Food and Drug Administration in December 2020, the author believes that home medical devices can be defined as medical devices that can be used by non-professionals in non-medical environments. This description contains 3 elements: non-medical environment, which refers to uncontrolled general use environment outside medical institutions, such as home, school, office, outdoor (non-wild, relatively stable environment), public places, etc.; non-professional, refers to Ordinary users who have not been trained or certified, such as consumers who directly use the device, patients, patient family members, and general nursing staff (non-professional nurses); use is a general concept that does not only refer to active interactive behaviors (such as installation, setup, operation, etc.). , storage, carrying, cleaning, disinfection, replacement of accessories, troubleshooting, discarding, etc.), as well as passive interactive behaviors such as understanding display information and receiving reminders.
According to relevant regulations and market conditions, the author divides household medical devices into the following categories: detection category, including blood pressure meters, blood glucose meters, electronic thermometers, etc.; treatment category, including household atomizers, magnetic therapy instruments, lumbar spine therapy instruments, etc.; Rehabilitation categories, including home oxygen concentrators, nursing beds, wheelchairs, etc.; health care categories, including massage pillows, massagers, nasal washes, etc.; in addition, infection control products (such as masks) that have been used on a large scale since the outbreak of COVID-19 , protective gloves, protective clothing, protective glasses, etc.), as well as physiological data collection wearable equipment, portable early screening equipment, portable dialysis equipment, blood glucose monitoring equipment, medical beauty products, etc.
Rich product line, vigorous household medical device industry
2022 05/13