Medical secondary qualification

The first category of medical devices includes: no need to apply for filing and qualification. The second category refers to medical devices whose safety and effectiveness should be controlled. Must apply to the relevant departments for the record. The third category refers to implantation into the human body; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Must obtain the "medical device business enterprise qualification". The second category of medical instruments includes: 680 1 basic surgical instruments; 6803 neurosurgical instruments; 6804 ophthalmic surgical instruments; 6806 pieces of oral surgical instruments; 6807 thoracic cardiovascular surgical instruments.

1. What are the 123 medical business licenses?

According to the new Regulations on the Supervision and Administration of Medical Devices (Order No.650th of the State Council) and the Code for Quality Management of Medical Devices, we must first understand that medical devices are divided into three categories: Class I, Class II and Class III. At present, it is not necessary to apply for a medical device business license to operate a class I product, a medical device business enterprise registration certificate to operate a class II product, and a medical device business license to operate a class III product.

Two, there are the following differences with the business license:

One can be sold without permission and filing, just add medical device sales to the business license.

The second category needs to apply for the Medical Device Business Record Certificate.

Only the third category needs to apply for a medical device business license.