Class III medical device registration number

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 X4XX5XXXXX6 number.

Which X1 for the registration and approval of the department of the location of the abbreviation.

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 in 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 "national" word.

Medical devices, two, three categories of differences:

First, the safety of different:

1, a class of medical devices through 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 implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.

So the third category of the highest security, the first category of 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) the word XXXX3 X4XX5XXXXX6.

Which X1 for the registration and approval of the department of the location of the abbreviation.

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 in 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, Macao for the "national" word.

Third, 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, sphygmomanometers, condoms (condoms) and so on.

3, Class III products: for example: masks. But the approval of a medical device in the end is classified to the side of a few classes is not a lifelong change, is determined by its safety, the State Bureau has the right to change its classification, such as masks in the general period of time are divided into a class, but in the period of SARS was classified as a class of two!