Medical devices can be divided into three categories:
The first category through routine management is sufficient to ensure the safety and effectiveness of medical devices medical devices.
Class II Medical devices whose safety and effectiveness should be controlled. Medical devices.
Class III for implantation in the human body, in support, life-sustaining; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices.
We can distinguish medical devices according to the medical device registration certificate number belongs to the first class, for example:
Registration certificate No. State Food and Drug Administration Measures (quasi) No. 2007 No. 3400842 No. 3 behind the word to determine that the medical device for the third class
Medical devices, registration certificate No. State Food and Drug Administration Measures (quasi) No. 2007 No. 2400542 No. 2 behind the word to determine that the medical device for the third class
Medical devices, registration certificate No. State Food and Drug Administration Measures (quasi) No. 2007 No. 2400542 No. 2 behind the word to determine that the medical device for the third class. The 2 to determine the medical device for Class II
But in terms of safety, some Class II medical devices usually do a class management. As follows:
The first batch of Class II medical devices that do not need to apply for a Medical Device Operator License
Class Code Name Product Name
General diagnostic instruments thermometers, sphygmomanometers
Physical therapy equipment Magnetic therapy appliances
Medical hygiene materials and dressings medical cotton wool, cotton wool, gauze, sanitary masks, and other medical equipment.
Clinical testing and analysis instruments home blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test side test strips) Medical polymer materials and products condoms, contraceptive caps
Ward care equipment and appliances wheelchairs
Dressings medical sterile gauze
The second batch of Class II medical device products do not need to apply for a "medical device business license Directory Electronic Blood Pressure Pulse Meter 6821 Plum Blossom Needles 6827 Prunus Needles 6827 Acupuncture Needles 6827
Ovulation Detection Test Strips 6840 Portable Oxygen Generator 6854
Note:
In the placement, we mainly look at the standard to be divided into, for example, some of the paste of the plasters, whose standard is the beginning of the State Drug Administration (SDAP), we must be placed in the category of topical medicines. In the category of the State Food and Drug Administration, and the State Food and Drug Administration, the beginning of the word mechanical permit need to be placed in the category of medical devices, disinfection supplies (consumer certificate word) and cosmetics (makeup) need to be separated into categories of reasonable placement.