What does it mean that Class II devices are exempt from filing?
The State Drug Administration in June 30, 2021 issued "exempted from the operation of the filing of the catalog of Class II medical devices," the announcement of the electronic blood pressure monitor, mercury blood pressure meter, sterile medical degreasing cotton, medical degreasing gauze, degreasing cotton gauze, condoms, condoms, electric wheelchairs, manual wheelchairs, blood glucose analyzers, blood glucose test strips, early pregnancy test strips, ovulation test strips. These categories of medical devices do not need to go to the drug regulatory department for the record.
Medical device license class I class II class III difference?
According to the latest "supervision and management of medical devices regulations" (State Council Decree No. 650) and "quality management standard for the operation of medical devices", first of all, we need to understand that medical devices are divided into three categories: Class I, Class II, Class III, the current operation of a class of products do not need to apply for a license for the operation of medical devices, operating class II products are required to apply for the second class of medical equipment business filing vouchers, the operation of Class III products is to apply for a medical device business license. The product is to apply for a medical device license.
The cost of a Class II medical device license?
This Class II medical device filing is no cost, the material to provide complete on the
Class II medical devices only physical examination without sales can not record?
The Class II medical device is not filing is required to register, in China the use and sale of medical devices need to be registered, so even though it is only experience, it is also to be registered.
Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are class II medical devices.
Class II refers to the safety and effectiveness of medical devices should be controlled. x-ray film machine, ultrasound, microscope, biochemistry belongs to Class II
Business license is not written in the first class of medical devices, written in the second class of medical devices, there is a record of the second class, you can operate the first class?
Medical device business supervision and management measures Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices for licensing management.