Class III 6854 Operating room, emergency room, diagnostic room equipment and apparatus
The State Food and Drug Administration has issued a classification definition of the text, as follows:
See "State Food and Drug Administration Measures [2004] No. 385"
State Food and Drug Administration defines the classification of products such as thoracic drainage regulator (2004-8-25) <
On August 6, 2004, the State Food and Drug Administration (SFDA) issued the Circular on Definition of Classification of Chest Drainage Regulators and Other Products (SFDA [2004] No. 385), which defines the classification of chest drainage regulators and other products as follows:
The ones managed as Class I medical devices are: chest drainage regulators, capsule-type oral inhalers for medicines.
Managed as Class II medical devices are: J-type urinary catheter, cataract ultrasonic emulsification system with negative pressure catheter, human body acid-alkali meter, medical air purification system, waist health care belt, ovulation detection test paper.
Managed as Class III medical devices: low-power ultrasound tumor therapeutic instrument, biological safety cabinet.
Not to be managed as medical devices: cosmetic wrinkle remover, oxygen stabilization tank, electric lifting tower, contact lens cleaner, multifunctional fetal education instrument.
Any of the above products defined as medical devices, from February 1, 2005 onwards to implement the adjusted categories.