Medical device registration number consists of six parts, the basic arrangement is: X (X) 1 Food and Drug Administration Measures (X2) word XXXX3 No. X4XX5XXXXX6.
Where X1 is the abbreviation of the location of the registration and approval department.
1, the territory of the first class of medical devices for the registration and approval of the department of the province, autonomous regions, municipalities directly under the Central Government abbreviation plus the abbreviation of the municipal administrative region.
2, the territory of the second class of medical devices for the registration and approval department of the province, autonomous region, municipality directly under the central government abbreviation.
3, the territory of the third class of medical devices, overseas medical devices and medical devices in Taiwan, Hong Kong and Macao for the "country".
Difference between the first, second and third class of medical devices:
One, the different safety:
1, a class of medical devices through the routine management is sufficient to ensure its safety and effectiveness.
2, Class II refers to its safety, effectiveness should be controlled medical devices.
3, Class III refers to the implantation of the human body; used to support, life-sustaining; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.?
So Class III has the highest safety and Class I the lowest.
Second, the registration number is different:
Medical device registration number consists of six parts, the basic arrangement is: X (X) 1 food and drug supervision and regulation of mechanical (X2) word XXXX3 No. X4XX5XXXXX6.
Where X1 is the abbreviation of the location of the registration and approval department.
1, the territory of the first class of medical devices for the registration and approval of the department of the province, autonomous regions, municipalities directly under the Central Government abbreviation plus the abbreviation of the municipal administrative region.
2, the territory of the second class of medical devices for the registration and approval department of the province, autonomous region, municipality directly under the central government abbreviation.
3, the territory of the third class of medical devices, overseas medical devices and medical devices in Taiwan, Hong Kong and Macao for the "country".
Three, the product is different:
1, a class of products: for example: external hemostatic patch. It should be noted that not all "hemostatic patch" is a class, some are Class II medical devices, some are chemical drugs, these have to be based on the nature of the product itself.
2, Class II products: such as: thermometers, blood pressure monitors, condoms (condoms) and so on.
3, Class III products: for example: masks. But the approval of a medical device in the end is classified into a few categories of the side is not the same for life, is determined by its safety, the State Bureau has the right to change its classification, for example, masks in the general period are divided into a class, but in the SARS period was classified as a class II!
Baidu Encyclopedia - Medical Device Registration Certificate