I don't know if I don't read it! It turns out that these are all medical devices!
When it comes to medical equipment, do you immediately think of X-ray machines, CT machines and other "tall" equipment? In fact, maker stickers, cotton swabs, contact lenses, etc. that we often come into contact with in our lives also belong to the category of medical devices. So, what exactly is a medical device? How are medical devices classified? Next, let's find out with the editor~
What is a medical device?
In my country, medical devices refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used on the human body, including required computer software. Its effectiveness is mainly obtained through physical methods, not pharmacological, immunological or metabolic methods, or although these methods are involved, they only play an auxiliary role.
It should be noted that the definition and scope of medical devices vary from country to country. For example, the medical devices used by pets are not within the scope of medical devices under the supervision of my country's Food and Drug Administration, but they are under the supervision of FDA in the United States.
How are medical devices classified?
In order to standardize the classification and management of medical devices, we usually divide medical devices into Class I, Class II, and Class III according to the degree of regulatory risk. However, products such as in vitro reagents and combination packages will be judged according to relevant regulations.
The first category is low-risk medical devices whose safety and effectiveness can be guaranteed by routine management, such as gauze, bandages, surgical gowns, examination gloves, etc.;
The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness, such as dentures, thermometers, blood glucose meters, hearing aids, non-absorbable sutures, etc.;
The third category is medical devices with higher risks that require special measures to be strictly controlled and managed to ensure their safety and effectiveness, such as intraocular lenses, implant devices, vascular stents, and dental implant materials.
How to judge the type of medical device?
If you cannot accurately determine the type of medical device, you can check the "Medical Device Classification Catalog" implemented on August 1, 2018 on the website of the State Drug Administration, and judge the corresponding product name. If you can’t judge according to the catalog, you can also go to the Medical Device Standard Management Institute of China Food and Drug Control Institute to classify and define medical devices, so that you can judge whether a product is a medical device and what types of medical devices it is.
At present, Class III medical devices have been fully included in the implementation scope of the unique identification of medical devices. In the future, the unique identification will gradually cover all devices. Wuxi Innovamed Technology Co., Ltd. (http://www.innovamed.com.cn/) can also provide companies with one-stop channels such as coding schemes, DI code applications, drug regulatory filings, original factory codes, and full process traceability. The traceability management solution helps enterprises meet the national traceability policy requirements.