There are three categories of medical devices——Class I, Class II, and Class III. Do you know the difference between these three categories?
The risk classification of medical devices is divided in detail, one of which is low risk, the second is medium risk, and the third is high risk. So let's see how these three categories differ!
Class I medical devices:
Class I medical devices are low-risk medical devices whose safety and effectiveness can be guaranteed through routine management. 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, etc.
The first class of medical devices, the number is: A equipment BBBBCCCC number
A means the abbreviation of the location, the imported medical device is "country", and the domestic medical device is the abbreviation of the provincial administrative region plus the abbreviation of the city administrative region, such as "Yuesui" means Guangzhou City, Guangdong Province.
B indicates the filing year
C means the filing serial number
Such as: National Equipment No. 20201234
Class II medical devices:
The second category has moderate risks and requires strict control and management to ensure its safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, ECG machines, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, condoms, etc. (The four meridians integrated intermediate frequency therapeutic instrument belongs to the second category)
Three types of medical devices:
The third category is a medical device with relatively high risk, which requires special measures to be strictly controlled and managed to ensure its safety and effectiveness. Such as: implantable cardiac pacemaker, corneal contact lens, intraocular lens, ultrasonic tumor focus knife, hemodialysis device, implanted equipment, vascular stent, comprehensive anesthesia machine, dental implant material, medical absorbable suture, Intravascular catheters, etc.
The second and third types of medical devices, numbered: A device note BCCCCDEEFFFF
A means the abbreviation of the location, the imported medical device is "country", and the domestic medical device is the abbreviation of the provincial administrative region.
B indicates the form of registration, "in" for import, "quasi" for domestic, and "xu" for Hong Kong, Macao and Taiwan.
C indicates the year of first registration
D indicates the management category, "2" indicates the second class medical device, and "3" indicates the third class medical device
EE represents the classification code, and the specific classification code can be viewed at the State Drug Administration.
F registers the serial number for the first time.
Such as: National Machinery Injection 20203401234
