Devices prefixed with "SINOMACH": standard of SINOMACH-belong to the third category of medical devices, and product registration and approval are managed by the State Administration of Medical Supplies. SINOMACH Injection: three kinds of domestic medical devices; Domestic machine injection: imported second-and third-class medical devices; Precautions for national machinery: Class II and III medical devices imported from Hong Kong, Macao and Taiwan; Domestic equipment: an imported medical equipment.
Taking Jiangsu and Suzhou as examples, talk about local medical devices: Xie Su Zhun: Class II medical devices within the jurisdiction of Jiangsu; Susu device: a kind of medical device in Suzhou area.
The serial number meaning of medical device registration certificate number: Take SINOMACH Note 20223408888 as an example, and 2022 is the year number, and the device was approved for registration in 2022; 3 is the category of device management, which belongs to three types of medical devices; 40 is the classification and coding category of instruments, belonging to in vitro diagnostic reagent products; 8888 is a four-digit serial number, which proves that you are the 8888th person to get the registration certificate this year.
Classification of mechanical products
The utility of mechanical brand products for human body surface and body is obtained by physical means, not by pharmacology, immunology or metabolism, but these means may participate and play a certain auxiliary role. Its purposes include: prevention, diagnosis, treatment, monitoring and rescue of diseases; Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability; Research, substitution and adjustment of anatomical or physiological processes; Pregnancy control, etc.
Medical devices are divided into three categories: the first category refers to medical devices that can ensure their safety and effectiveness through routine management, such as masks, band-AIDS, surgical instruments, etc. The second category refers to medical devices whose safety and effectiveness should be controlled, such as sphygmomanometer, blood glucose meter, salt sol therapeutic instrument, etc.
The third category refers to implantation into the human body; Used to support and sustain life; Medical devices that are potentially dangerous to human body and whose safety and effectiveness must be strictly controlled, such as disposable sterile syringes/infusion sets, vascular stents, artificial organs, etc.