Notice on classification of products such as plastic bag sealing machine (medical sealing machine see article 28)
China food and drug supervision 154
(from the state food and drug administration website, http://www.sda.gov.cn/WS01/CL0055/10379.html
Issued on 15 April 2005
The food and drug administration of the provinces, autonomous regions and municipalities directly under the central government (fda)：
In order to adapt to the needs of the supervision and management of medical devices, the classification and definition of 42 products, such as oral digital observation instrument, are given as follows.：
一、Oral digital observation device: used for oral observation. As a medical device management of class I.
二、Contrast sensitivity test card: used for visual functional testing, evaluation and diagnosis of visual impairment. As a class II medical device management。
三、Stereo test card: used to test the stereo vision function. As a medical device management of class I。
四、Ophthalmic lens: used to assist ophthalmological examination and increase the Angle of observation. As a medical device management of class I。
五、Somatic cell therapy medium: management of class III medical devices。
六、Multi-functional pants: used for patient care and bedsore prevention and treatment of incontinence. As a medical device management of class I。
七、Microneedle tablets (no medicine) : used for skin administration. As a class II medical device management。
八、Penile grower: used for lengthening the penis, correcting the curvature of the penis, and treating the penis after surgery. Management of class III medical devices。
九、Ozone therapy instrument: to produce ozone, through the catheter into the rectum or vagina to treat vaginitis, vulvitis, cervicitis and gastroenteritis. As a class II medical device management。
十、Facial maxillofacial bone grinding machine: used for facial plastic surgery. As a class II medical device management。
十一、Fat transplanter: it is made from water injection machine, liposuction machine and fat purification unit. It is used for fat transplantation. Management of class III medical devices.。
十二、Microcrystalline grinding treatment instrument: the fine crystal particles in high speed spray to the skin, fast, moderate stripped the skin cutin layer, to improve aging skin, remove superficial spot and acne scars, improve the stratum corneum, the skin wrinkles, reduce freckle, superficial freckles, shrink pores, remove black heads and acne, treatment of eyelid xanthoma, vulvar syringomas. As a class II medical device management。
十三、multi-function wavelength multiplexing medical lasers used in deep skin anti-wrinkle and improve big pores and blackheads, remove hair, tattoos, eyebrow tattoo, tattoo, improve pigment spots, acne scars, seborrheic skin, treatment of nevus of ota, moles, nevus flammeus, spider capillaries expansion. Management of class III medical devices.
十四、High frequency doppler ultrasonography: used for 2D and 3D imaging of the skin. As a class II medical device management.
十五、Bone bed cleaning system: used to clean blood and debris from the bone surface during orthopedic surgery. As a class II medical device management.
十六、Dissecting/grasping forceps: with a thorn, used for minimally invasive surgery, and with endoscope for grasping and shearing. As a class II medical device.
十七、Atomization filter: disposable, connected to the tracheal tube, used for respiratory filtration, heat preservation and humidification, to maintain the smooth airway. As a class II medical device management.
十八、Snoring: used to keep the mucous membranes of the nasal cavity and throat moist, reducing snoring while sleeping. If it does not have pharmacological effect, it is managed as class II medical device.
十九、Bone cement casing assembly: used for mixing and conveying bone cement. As a medical device management of class I.
二十、The chemical analyzer is used in the test of electrolyte solution and polymerization of potassium, sodium and chloride ion potential. As a medical device management of class I.
二十一、The biochemical analyzer used 7% bovine serum albumin: the reaction component was 7% bovine serum albumin, which was used as a diluent to test the serum samples of people who exceeded the linear range of the system. As a medical device management of class I.
二十二、The biochemical analyzer USES a special diluent: the reaction component is human serum, and as a diluent, it is used to test the serum samples of people whose results are beyond the linear range of the system. As a medical device management of class I.
二十三、The biochemical analyzer USES citric acid solution: an aqueous solution of citric acid and preservative to stabilize acid phosphatase in serum/blood samples. As a medical device management of class I.
二十四、The biochemical analyzer is used to test the immune rate method by using the immune rinse solution: water-soluble matrix solution. As a medical device management of class I.
二十五、Biochemical analyzer with magnetic in HDLC reagents: used for sample pretreatment, the precipitation/serum low density lipoprotein and low density lipoprotein in the blood, with magnetic removal of precipitation of lipoprotein, high density lipoprotein cholesterol (hdl-c) on a clear night. As a medical device management of class I.
二十六、Stitching: used for fixing stitches in surgery. Stitches are no longer tied. As a medical device management of class I.
二十七、Distilled water machine: used for preparing distilled water. Not as a medical device management.
二十八、Sterilizing bag sealing machine: used for sealing the sterilization packaging bag. Not as a medical device management.
二十九、Dental phone cleaning and curing machine: used for cleaning and lubrication of medical dental phones. Not as a medical device management.
The above products are defined as medical devices, and the adjusted categories will be implemented from 1 November 2005. From the date of publication, the food and drug administration department may accept the application for registration of such products.