How to distinguish the authenticity of medical devices from the packaging labels

1、 Look at the medical device registration certificate number

（1） To see if the arrangement of registration certificate number is correct The arrangement of medical device registration certificate number is as follows: a (A1) (food) drug regulatory equipment (A2) Zi aaaaaa3 No. a4aa5aaa6; "A1" is the abbreviation of the place where the registration approval department is located; "A2" registration type; "aaaaaa3" is the year of approval of registration; "A4" is the commodity management category; "aa5" is the commodity category code; "aaaaaaa6" is the registration serial number; for example, the consumption approved by Jiangsu drug administration in 2003“ The correct arrangement of registration certificate number is: sjgx (test) No. 2050036, 2003, otherwise, it is wrong.

（2） To see whether the registration method of the registration certificate number can be correct, the registration method is divided into "quasi, Jin, Xu, try". (quasi): refers to domestic equipment; (import): refers to overseas equipment; (permit): refers to equipment in Hong Kong, Macao and Taiwan; (Trial): refers to equipment for trial consumption.

（3） The invalid period of medical device registration certificate is usually 4 years, and that of trial production products is two years.

（4） To see whether the commodity management category in the registration certificate number can be correctly consumed, the consumption of class III equipment shall be approved by the Provincial Bureau, and the consumption of class I equipment shall be approved by the Municipal Bureau. Class III devices must be marked as "3" in the "commodity management category" (A4); class II devices must be marked as "2" in the "commodity management category"; otherwise, they are all wrong.

（5） To see whether the commodity type code in the registration certificate number is correct, according to the classification catalogue of medical devices, different types have different codes. For example, the code of disposable syringe is "15", and (aa5) should be marked as "15". If the registration number of pilot production (5) is "A2", then the registration should be terminated.

2、 See "medical device registration and approval form"

The medical device registration certificate only indicates the agreed certificate number and medical device title, while the function, composition, commodity specification, specification and model, scope of application, and consumption address of the commodity can be reflected only from the "approval form". Therefore, when examining the registration certificate, it is necessary to check whether the contents approved in the medical device registration and approval form are different from the commodity identification content. For example, Lianshui Bureau seized a disposable surgical information package marked as consumption by a medical supplies factory in Hanjiang, Yangzhou city. The package contained medical rubber gloves, but the functional structure and composition of the commodity in the "approval form" did not contain such accessories. Another example is the disposable ECG electrode consumed by a medical device unlimited company in Shanghai. The specification of the cancellation form is plt-pi-60, while the specification of the statement and the package label is plt-60.

3、 Look at the number of medical device consumption permit

The correct format of the consumption license number is: B1 drug control equipment consumption license bbbbbb2bbb3 (B1: refers to the province where the approval department is located, bbbbbb2: refers to the year of approval, bbbbbb3: refers to the serial number).

4、 Look at the scope of application